Tag: weight loss

Early advanced therapy significantly improves Crohn’s disease outcomes

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A large-scale clinical trial of treatment strategies for Crohn’s disease has shown that offering early advanced therapy to all patients straight after diagnosis can drastically improve outcomes, including by reducing the number of people requiring urgent abdominal surgery for treatment of their disease by ten-fold.

The PROFILE trial, led by researchers at the University of Cambridge, involved 386 patients with newly-diagnosed active Crohn’s disease. Recruiting from 40 hospitals across the UK, and supported by the National Institute for Health and Care Research (NIHR) Clinical Research Network, it sought to test whether a biomarker – a genetic signature – could predict which patients were at greatest risk of relapses of their condition, and to test two different approaches to treating the disease.

Crohn’s disease is a life-long condition characterised by inflammation of the digestive tract. It affects around one in 350 people in the UK. Even at its mildest, it can cause symptoms that have a major impact on quality of life including: stomach pain, diarrhoea, weight loss and fatigue. Typically patients experience ‘flares’ of inflammation, where their condition worsens for a time, producing more symptoms and progressive bowel damage. As many as one in 10 patients will require urgent abdominal surgery to treat their condition within their first year of diagnosis.

The findings of the PROFILE trial, sponsored by Cambridge University Hospitals (CUH) NHS Foundation Trust and the University of Cambridge, are published today in The Lancet Gastroenterology and Hepatology. While the biomarker did not prove useful in selecting treatments for individual patients, a ‘top-down’ treatment strategy involving use of the drug infliximab straight after diagnosis, showed dramatic results.

Infliximab works by blocking a protein found in the body’s immune system, TNF (tumour necrosis factor)-alpha, which plays an important role in inflammation. The drug is administered through regular intravenous infusions directly into the bloodstream or injections under the skin. However, due to historical concerns about cost and side-effects – including an increased risk of infection related to immunosuppression – it is currently only offered when patients experience regular flare-ups that do not respond to less potent treatments.

In the PROFILE trial, patients were assigned at random to one of two treatment groups. Each group was given a different treatment strategy and patients were followed up over the course of a year.

The first group was treated using an ‘accelerated step-up’ approach, which is the conventional treatment strategy used in the UK and across most countries around the world. In this group, patients only started on infliximab if their disease was progressing and not responding to other simpler treatments.

The second group, however, was treated using ‘top-down’ therapy – that is, they were provided with infliximab as soon as possible after their diagnosis, regardless of the severity of their symptoms.

The results were dramatic: 80% of people receiving the top-down therapy had both symptoms and inflammatory markers controlled throughout the course of the entire year compared to only 15% of people receiving the accelerated step-up therapy.

Two-thirds (67%) of patients in the ‘top-down’ group had no ulcers seen on their endoscopy camera test at the end of the trial – something known as endoscopic remission. Endoscopic remission is considered very important as this has been consistently associated with decreased risk of later complications in Crohn’s disease. Most previous clinical trials of therapies have been considered highly successful based on getting 20 to 30% of patients into endoscopic remission.

As well as these findings, patients in the top-down arm also had higher quality of life scores, less use of steroid medication and lower number of hospitalisations.

Strikingly, while around one in 20 patients (5%) in the conventional treatment arm of the trial required urgent abdominal surgery for their Crohn’s disease, only one in 193 (0.5%) receiving the ‘top-down’ therapy required such surgery.

Dr Nuru Noor from the Department of Medicine at the University of Cambridge, one of the study’s lead researchers and first author of the trial, said: “Historically, treatment with an advanced therapy like infliximab within two years of diagnosis has been considered ‘early’ and an ‘accelerated step-up’ approach therefore ‘good enough’. But our findings redefine what should be considered early treatment.

“As soon as a patient is diagnosed with Crohn’s disease, the clock is ticking – and has likely been ticking for some time – in terms of damage happening to the bowel, so there’s a need to start on an advanced therapy such as infliximab as soon as possible. We’ve shown that by treating earlier, we can achieve better outcomes for patients than have previously been reported.”

In fact, say the researchers, the improvements seen among the trial patients receiving ‘top-down’ therapy might be even more stark compared to usual clinical care. Few patients with Crohn’s disease in standard clinical care receive the rapid, ‘accelerated step-up’ approach provided by the trial protocol, and so the benefits of implementing a ‘top-down’ approach in standard clinical care might be even more pronounced.

Crucially, the team found no difference in risk of serious infection between treatment strategies, suggesting that infliximab straight after diagnosis was well tolerated, contrary to previous concerns about its safety. In addition, the cost of the drug, which is now an off-patent, generic and ‘biosimilar’ medicine, has fallen considerably from around £15,000 to around £3,000 per patient per year.

Up until now, the view has been ‘Why would you use a more expensive treatment strategy and potentially over-treat people if there’s a chance they might do fine anyway?’

As we’ve shown, and as previous studies have demonstrated, there’s actually a pretty high risk that an individual with Crohn’s disease will experience disease flares and complications even in the first year after diagnosis.

We now know we can prevent the majority of adverse outcomes, including need for urgent surgery, by providing a treatment strategy that is safe and becoming increasingly affordable. If you take a holistic view of safety, including the need for hospitalisations and urgent surgery, then the safest thing from a patient point of view is to offer ‘top-down’ therapy straight after diagnosis rather than having to wait and use ‘step-up’ treatment.”

Professor Miles Parkes, Chief Investigator of the PROFILE trial, Director of the NIHR Cambridge Biomedical Research Centre

The PROFILE team are now actively working on an analysis of the health economics to see whether the benefits of the therapy outweigh its cost.

Professor Parkes added: “It’s not just those five per cent of people requiring surgery that we need to think about. In the ‘step-up’ arm lots of people experienced disease flares without necessarily needing surgery. And every time somebody flares, they require several consultations with specialist doctors and nurses, clinical investigations such as scans and colonoscopies, time off work, time out of education and so on – all leading to major impacts on quality of life for individuals.”

While there are other anti-TNF drugs, such as adalimumab, that work in a similar manner to infliximab and are significantly cheaper, more research is required to understand if it would be as clinically effective.

Ruth Wakeman, Director of Services, Advocacy & Evidence at Crohn’s & Colitis UK said: “Crohn’s Disease affects over 200,000 people in the UK and we know that many of them have symptoms for a long time before they are diagnosed. But diagnosis is not the end of their journey, and the trial and error involved in finding the right treatment can be challenging and distressing.

“This study shows what a dramatic difference early treatment with advanced therapy can make to newly-diagnosed patients. People with Crohn’s don’t want to be stuck in hospital or having surgery, they want to be out in the world, living their lives. Anything that speeds up the path to remission can only be a good thing.”

The research was funded by Wellcome and PredictImmune Ltd and supported by the NIHR Cambridge Biomedical Research Centre.

“If the drug had been offered in the first place, things could have been very different.”

Toby Moore, 28, was just ten years old when it became clear there was something wrong.

“I was at primary school at the time and was getting lots of abdominal pain, lots of going to the toilet and vomiting, low energy levels – I was effectively unable to consume any food or drink without some kind of problem. It was just terrible.”

He visited the GP repeatedly over six months, where among other things he was told it was due to the stress of Year Six exams. He says that for his mother and father, it was probably the most challenging time of their lives as parents.

“I was eventually referred to a paediatric gastroenterologist specialist who within 30 seconds of looking at me said, ‘Right. I think you have Crohn’s disease. I’d like to do these tests,’ and off we went.”

The specialist was correct. He put Toby on an ‘elemental diet’ to manage his condition, which meant that for six weeks he could eat no food or drinks (other than water), only prescription shakes aimed at allowing his digestive system to heal. Toby then had to reintroduce different foods into his diet to see if they could identify what triggered his condition.

Not long afterwards, he had a ‘flare up’, with his symptoms worsening significantly. His local Peterborough hospital was unable to help and so he was referred to the Royal Free Hospital in London. There, his parents had to make the difficult decision of whether he should receive abdominal surgery or go onto biologic medication. They chose the latter, and Toby was put on infliximab.

“If you asked my parents now, they’d call it a light switch drug. I was infused with it on a Thursday and by the Sunday I was a different person. I was eating, drinking, my symptoms had stopped. It was unbelievable. Arguably, if that had been offered in the first place instead of the lighter approach, things could have been very different.”

Toby was on infliximab for several years, but was taken off the drug in late secondary school when he became unwell – “not in a Crohn’s disease way, something else was going on”. He was taken into hospital, where the doctors immediately stopped the treatment, concerned it was a trigger.

Toby was transferred to Addenbrooke’s Hospital, where Dr Miles Parkes took over his treatment. It turned out that Toby also had large vessel vasculitis, another autoimmune condition. Whereas Crohn’s affects your digestive system, this affects blood vessels. It causes the aorta, the main blood vessel in your body, to become narrowed, which causes symptoms including weight loss, unexplained lower back pain and fatigue.

Since then, Toby has been on a number of different biologic treatments, each working for a while before their effects wear off, he experiences another flare up, and is prescribed a different drug. Were it not for the drugs, he says his life would be very different.

“It can be quite debilitating, especially when it’s flaring up, as I’m sure you can imagine, when you have minimal control over certain bodily functions. It’s not the most pleasant.”

His current medication, upadacitinib, involves taking a daily pill. It has helped him manage his condition – flare ups aside – allowing him to live a relatively normal life, hold down a steady job as a chef in a local hospice , close to where he lives, and start a family. But he still has to be very careful.

“Where possible I try to avoid stressful situations that life throws at you. When you live at your mum and dad’s life’s a bit more simple, you’ve got a few less responsibilities, so stress is slightly less, but when you go out into the big wide world – and I’ve got a two-and-a-half year old daughter now – that obviously adds a new dynamic to your life!”

Toby has nothing but praise for the NHS. “They’ve been just phenomenal. Miles is very good at nipping things in the bud straight away. He always actions things, he doesn’t just say, ‘Well, we’ll see how you are in a month’. So it never gets too out of control. My opinion of the NHS is really, really high. They’ve been a lifeline for me.”

Source:

Journal reference:

Noor, N. M., et al. (2024) A biomarker-stratified comparison of top-down versus accelerated step-up treatment strategies for patients with newly diagnosed Crohn’s disease (PROFILE): a multicentre, open-label randomised controlled trial. The Lancet Gastroenterology & Hepatology. doi.org/10.1016/S2468-1253(24)00034-7.

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February 22, 2024
How does intermittent fasting affect the gut microbiome?

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In a recent study published in the journal Frontiers in Nutrition, a group of researchers evaluated how various intermittent fasting (IF) regimens impact the composition of the human gut microbiome.

Study: The impact of intermittent fasting on gut microbiota: a systematic review of human studies. Image Credit: Tatiana Shepeleva / Shutterstock

Background

Fasting, the voluntary avoidance of food and drinks, varies from calorie restriction (CR), which reduces daily calorie intake without causing malnutrition. Fasting is categorized into IF and prolonged fasting (PF), with PF involving water-only consumption for two or more days. IF is popular in various lifestyles, religions, and cultures, encompassing methods like time-restricted eating (TRF), where food intake is limited to 12-18 hours daily, alternate day fasting (ADF), and the 5:2 diet, which alternates between fasting and unrestricted eating days. While TRF may not reduce overall calorie intake, ADF limits calories to about 25% of daily needs on fasting days. Research indicates IF benefits weight loss, blood pressure, anti-inflammatory responses, and metabolic health, partly through modifications in the gut microbiota, impacting glucose metabolism and inflammation. Further research is needed to clarify the specific effects of IF on the human gut microbiome and its implications for health due to the current heterogeneity and limited scope of existing studies.

About the study

The present review explored IF effects on gut microbiota, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)2020 guidelines and registered with the International Prospective Register of Systematic Reviews (PROSPERO). Initial and follow-up searches across four databases targeted English studies up to 2021, including direct author contacts, to ensure comprehensive IF research coverage.

The review’s inclusivity spanned various IF modalities, initially focusing on TRF before expanding to ADF and the 5:2 diet in response to the scarcity of TRF-specific research. Exclusions were made for non-human, observational, and non-experimental studies, among others, favoring randomized controlled trials, quasi-experimental studies, and pilot studies without restrictions on participant demographics.

The selection process involved a thorough screening of titles and abstracts by three independent reviewers, utilizing Rayyan Qatar Computing Research Institute (QCRI) for efficient collaboration and conflict resolution. This initial phase reduced the pool from 1,172 records to 22 potential studies, further narrowed down through consensus after full-text review. The expansion of inclusion criteria and a second search round eventually enriched the review with eight pertinent studies despite the initial limitation to TRF studies.

Data extraction was evenly distributed among reviewers, focusing on outcomes related to gut microbiota diversity and composition alongside study and participant characteristics without making assumptions about unclear data. The risk of bias was rigorously assessed using Cochrane’s tools, facilitating an unbiased and thorough synthesis of the available evidence on the impact of IF on gut microbiota.

Study results

The present systematic review process precisely outlined the search and selection stages, leading to a critical evaluation of the included studies for risk of bias, utilizing Cochrane’s tools. This appraisal revealed varied levels of bias, highlighting a need for a cautious interpretation of the findings.

The review delved into the intricacies of IF impacts on gut microbiota, dissecting the methodologies employed across studies to assess microbiota composition and diversity. Through this exploration, it emerged that while several studies observed changes in microbiota richness and diversity, the findings were not uniformly consistent, indicating a complex interplay between IF and gut microbiome dynamics.

Analyses of gut microbiota richness and diversity across studies on IF showed varied outcomes, indicating IF’s significant but variable impact on the gut microbiome is influenced by demographic and dietary factors. Beta diversity assessments revealed distinct shifts in microbial communities under different IF protocols, highlighting the diet’s personalized effects on gut health. Moreover, the composition of gut microbiota demonstrated both consistent and varied changes in bacterial populations, reflecting the complex influence of IF on the gut ecosystem. This variability suggests IF’s effects are shaped by the specific fasting approach, individual dietary habits, and baseline microbiome characteristics, pointing to an interaction between diet and gut health.

Additionally, the review illuminated the broader physiological and metabolic implications of IF, including weight loss and dietary changes, across various forms of fasting. While some studies reported significant weight reduction and alterations in energy intake, others highlighted the stability of macronutrient percentages or shifts in food group consumption, painting a complex picture of IF’s influence on diet and body composition.

The differential findings across TRF, ADF, and 5:2 diet studies not only reflect the diverse methodologies and populations studied but also hint at the potential for IF to induce specific microbiota and metabolic changes, contingent upon the nature and context of the fasting intervention. As revealed through this review, the variations in dietary intake and its subsequent impact on weight and metabolic health emphasize the intricate relationship between fasting practices, nutritional status, and gut microbiome composition.

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February 15, 2024
Bariatric surgery more effective in controlling hypertension rates in obese patients

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Bariatric surgery is more effective in controlling hypertension rates, or high blood pressure, in people with obesity and uncontrolled high blood pressure compared to blood pressure medication alone, according to a study published today in the Journal of the American College of Cardiology. People who underwent bariatric surgery had lower BMI and were on fewer medications after five years while maintaining normal blood pressure levels than those who only used antihypertensive medications.

According to the CDC, the U.S. obesity and hypertension rates in adults are 41.9% and 45.4%, respectively. Obesity is a known risk factor for cardiovascular disease and a major contributor to high blood pressure, which can make a person more susceptible to heart attack, stroke and heart failure, among other risks.

In clinical practice, obesity is an overlooked condition. As a consequence, there is a frequent failure in approaching obesity as a crucial step for mitigating the risk of important cardiovascular risk factors including hypertension.”

Carlos Aurelio Schiavon, MD, FACS, lead author of the study and a surgeon specializing in bariatric surgery at Heart Hospital (hcor) and BP Hospital in Sao Paulo

Researchers in this study looked at the impact of treating obesity to lower high blood pressure. While there are new medications to treat obesity, long-term adherence to medication can be challenging. This study looks at bariatric surgery as a better long-term solution to control obesity and, as a result, high blood pressure.

The GATEWAY trial included 100 people (76% of which were female) who had a body mass index (BMI) of around 36.9Kg/m². All participants had hypertension and were using at least two medications. People with previous cardiovascular events and poorly controlled Type 2 diabetes were excluded. Subjects were assigned to either Roux-en-Y gastric bypass with medical therapy or medial therapy alone and the primary outcome was reduction of at least 30% antihypertensive medications while maintaining blood pressure levels less than 140/90 mmHg at five years.

At five years, BMI was 28.01 Kg/m²for those who received bariatric surgery and 36.40 Kg/m²for those on medical therapy alone. People who had bariatric surgery had an 80.7% reduction in the number of medications they were taking compared to a 13.7% reduction in those only using medical therapy. Hypertension remission, defined as controlled blood pressure without medications, was 46.9% in those who underwent bariatric surgery compared to 2.4% in those on medical therapy alone.

“Our results underscore the importance of approaching obesity in reducing hypertension rates,” Schiavon said.

Limitations of the study include that it was a single-center, open-label study with a small sample size and there was loss of follow up in some patients.

In an accompanying editorial comment, Michael Hall, MD, MSc, professor and chair of the Department of Medicine at the University of Mississippi Medical Center, said the study provides important long-term data on the benefits of gastric bypass on weight loss and blood pressure control, but questions remain.

“Further studies assessing the threshold for bariatric surgery in people with obesity, optimal timing of bariatric surgery in obese people with cardiometabolic diseases, type of bariatric surgery and comparative studies of obesity pharmacotherapies and bariatric surgery are needed to clarify the optimal treatment pathways for this common and growing disease,” he said.

Source:

American College of Cardiology

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February 6, 2024
Ozempic and Wegovy: The science and side effects behind the semaglutide weight loss drugs

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Ozempic can help people to quickly lose weight but may also have serious side effects

Ute Grabowsky/imageBROKER/Shutterstock

Ozempic and Wegovy are brand names for the drug semaglutide. Many countries have approved Wegovy for weight loss in people who are obese or overweight and Ozempic for people with type 2 diabetes.

How do these drugs work?

Drugs such as semaglutide mimic the actions of a hormone called glucagon-like peptide-1, or GLP-1. These so-called GLP-1 analogues have several effects, including slowing stomach emptying, acting on the brain to reduce appetite and boosting the release of insulin, which helps to regulate blood sugar levels.

For more than a decade, GLP-1 analogues have been used to help people with type 2 diabetes control their blood sugar and some users experienced modest weight loss. “These drugs augment a system that already exists within the human body, whose role it is to suppress appetite following meal ingestion,” says Simon Cork at Imperial College London.

Why are they making headlines now?

GLP-1 analogues have started to be prescribed for weight loss in people without type 2 diabetes. They have also become available in formulations that are more potent and easier to use.

Initially GLP-1 analogues were approved for use at a lower dose and needed to be given by twice-daily injections. In the latest formulations they are once-weekly injections, with Wegovy’s full dose being 2.4 milligrams for weight loss and Ozempic being used at a maximum dose of 2 milligrams for type 2 diabetes.

How widely available are they?

In 2021, Wegovy was approved for weight loss in several countries, including the US and Canada. Praise from some celebrity users brought it widespread publicity.

Manufacturing problems meant its manufacturer, Novo Nordisk, had trouble meeting global demand, so some doctors started prescribing Ozempic, which had been approved for people with type 2 diabetes in certain countries several years earlier. This led to shortages for people who required it for diabetes control.

In the UK, Wegovy was approved in 2021, but only got the nod from England’s medical guidelines body the National Institute for Health and Care Excellence in March 2023, when it said the drug should be given by weight loss clinics within the country’s national health service. Wegovy is expected to become available in the UK this year, while Ozempic has been available for type 2 diabetes since 2019.

In June 2023, the UK government announced the introduction of a two-year pilot that gives people with obesity access to new drugs, such as Wegovy, outside of a hospital setting.

How effective are they?

Very. It is a cliche but obesity doctors are talking about a paradigm shift in the field of obesity management. Previously, a loss of about 5 per cent of body weight would be considered a good result for any weight loss intervention outside of stomach surgery and is considered a benchmark in obesity drug trials.

Wegovy leads to about a 15 per cent reduction in body weight over a year, when combined with exercise and eating healthily.

In fact, some people seem to feel that the GLP-1 analogues have caused them to become too gaunt, as reflected in the rise of the search terms “Ozempic face” and “Ozempic butt”. “Ozempic doesn’t do anything specific to the skin,” says Alexander Miras at Ulster University, UK. It is the weight loss that causes these apparent side effects, with similar outcomes often also occurring after weight loss surgery, he says.

Do the drugs have any side effects?

Side effects can be mild, such as nausea, constipation and diarrhoea, which tend to occur as people get used to the drug. More worrying side effects include inflammation of the pancreas, although this is relatively rare.

How about hair loss?

Hair loss has been reported by some semaglutide users. This is also sometimes seen after significant weight loss from other causes, such as stomach surgery, says Miras.

Hair loss following weight loss surgery is thought to be due to physiological stress on the body causing an increased number of hair follicles to enter their “resting” phase, which leads to the hairs falling out a few months later. It stops when the weight loss stabilises, however, the hair doesn’t always grow back, says Miras.

Do these drugs cause suicidal thoughts?

GLP-1 analogues – such as Ozempic and Wegovy – are being investigated by the European Medicines Agency (EMA) after recent reports that they may cause thoughts of suicide or self-harm. This was after Iceland’s health regulator received three such reports regarding semaglutide and another drug called liraglutide, which is an earlier GLP-1 analogue.

The EMA says it is analysing about 150 reports of possible cases of self-injury and suicidal thoughts. This doesn’t mean the medicines caused these effects, however, only that people reported these experiences after starting to take them. “More work is needed to determine if a causal link exists,” says Michael Schwartz at the University of Washington in Seattle.

A spokesperson at Novo Nordisk, the manufacturer of liraglutide and the semaglutide drugs Ozempic and Wegovy, told New Scientist: “GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for eight years. The safety data collected from large clinical trial programmes and post marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.”

Need a listening ear? UK Samaritans: 116123; US 988 Suicide & Crisis Lifeline: 988; hotlines in other countries.

Do these drugs help with addictions?

Perhaps. There have been many anecdotal reports of people taking these medicines for diabetes or weight control who lose their urge to drink alcohol or see waning of other habits that could be described as “behavioural addictions”, such as compulsive shopping.

This is supported by research in animals that found the GLP-1 analogues lower consumption of alcohol and addictive drugs. A small trial in people has hinted at a similar effect from a GLP-1 analogue called exenatide, which reduced heavy drinking, but only in people who were obese.

The explanation could be connected with the way the drugs act on the brain to reduce food cravings, but the exact mechanism is unclear. We are only at the beginning of understanding how these treatments could support people with alcohol and drug additions, says Daniel Drucker at Sinai Health in Toronto, Canada. “The clinical trial data is not yet in to substantiate the anecdotes.”

What happens to a user’s weight long-term?

The longest trial of Wegovy lasted two years and found that people’s weight broadly plateaued in the second year.

In most countries, Wegovy has been approved for two years’ use, but if people stop taking the drug, they generally regain the lost weight – two-thirds of it after one year, according to one trial.

“The weight loss is only sustained for as long as the drug is taken because as soon as you stop the drug, all of those physiological processes that are trying to get your body weight back up kick in again,” says Cork.

This suggests that after two years of use, there will be demand from consumers for doctors to continue prescribing the drug “off label”. “I think there’ll be a big push to try to change those guidelines,” says Cork.

Ozempic can be prescribed long-term for type 2 diabetes because the condition is usually life-long.

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February 6, 2024
New weight loss drug may be an effective strategy for preventing or treating high blood pressure
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The new weight loss medication tirzepatide significantly lowered the systolic blood pressure (the top number in a blood pressure reading) for nearly 500 adults with obesity who took the medication for about eight months, according to new research published today in Hypertension, an American Heart Association journal.

Systolic blood pressure, or the top number in the blood pressure reading, is a stronger predictor for cardiovascular death than diastolic, or bottom number, blood pressure. According to the American Heart Association’s 2024 Heart Disease and Stroke Statistics, more than 122 million adults in the United States, or 47% of adults have hypertension, and nearly 42% of adults have obesity.

Tirzepatide works by mimicking two metabolic hormones in the body: it acts as a glucagon-like peptide-1 (GLP-1) receptor agonist and also as a glucose dependent insulinotropic polypeptide (GIP) receptor agonist. These hormones stimulate insulin secretion and sensitivity after a person eats. Together, they have been found so far to help regulate the body’s blood sugar levels, slow down digestion and reduce appetite, which makes a person feel more full and eat less, leading to weight loss. In contrast, semaglutide has only the GLP-1 hormone; it does not contain a GIP receptor agonist.

In 2022, the Food and Drug Administration approved tirzepatide for prescription as a treatment for Type 2 diabetes. In late 2023, the FDA also approved it for chronic weight management for people with obesity (body mass index of 30 kg/m² or higher) or overweight (body mass index of 27-29 kg/m²) and at least one weight-related health condition, such as high blood pressure, Type 2 diabetes or high cholesterol.

“Our findings indicate treating obesity with the weight loss medication tirzepatide may be an effective strategy for preventing or treating high blood pressure,” said lead study author James A. de Lemos, M.D., FAHA, the Kern Wildenthal, M.D., Ph.D., distinguished chair of cardiology and a professor of medicine at UT Southwestern Medical Center in Dallas. “Although tirzepatide has been studied as a weight loss medication, the blood pressure reduction in our patients in this study was impressive. While it is not known if the impact on blood pressure was due to the medication or the participants’ weight loss, the lower blood pressure measures seen with tirzepatide rivaled what is seen for many hypertension medications.”

The current research was a planned sub-study including 600 of the participants from the SURMOUNT-1 weight loss study to determine if there was an effect on blood pressure. The sub-study was designed to assess the effects of tirzepatide on blood pressure levels as measured by 24-hour ambulatory blood pressure monitoring in people with obesity but without Type 2 diabetes.

Participants received either a placebo or a dose of tirzepatide in one of three strengths (5 mg, 10 mg or 15 mg). About one-third of participants reported they had high blood pressure at the beginning of the study and were taking one or more hypertension medications. When the sub-study began, all of the participants had blood pressure levels that were less than 140/90 mm Hg, and if they used blood pressure medications, they were required to have been taking their blood pressure medications for at least three months. The sub-study included participants who had hypertension and who had normal blood pressure.

The study was conducted from December 2019 to April 2022, and the participant results after 36 weeks of taking tirzepatide indicate:
- For participants taking 5 mg of tirzepatide, there was an average reduction in systolic blood pressure of 7.4 mm Hg.
- For participants taking 10 mg of tirzepatide, there was an average reduction in systolic blood pressure of 10.6 mmHg.
- For participants taking 15 mg of tirzepatide, there was an average reduction in systolic blood pressure of 8.0 mm Hg.
- The blood-pressure lowering effects of tirzepatide were evident in blood pressure measures taken during both the day and night. Nighttime systolic blood pressure is a stronger predictor for cardiovascular death and all-cause death than daytime blood pressure readings.
The reductions in systolic blood pressure were consistent across subgroups of participants in the study who were categorized by additional factors, including age, sex, body mass index and hypertension-related risk factors.

Study background and details:
- SURMOUNT-1 was a randomized study on the effect of increasing doses of tirzepatide on weight loss. It found that in participants with overweight or obesity (body mass index (BMI) ≥27 kg/m²), once-weekly injections of 5 mg, 10 mg or 15 mg of tirzepatide led to mean weight reductions of 15%, 19.5% and 20.9%, respectively, compared to placebo.
- The sub-study included 600 adults from SURMOUNT-1: 155 participants received placebo; 145 were taking tirzepatide 5 mg; 152 were taking tirzepatide 10 mg; and 148 were taking tirzepatide 15 mg.
- Blood pressure measurements were available and analyzed for 494 participants who valid ambulatory blood pressure monitoring data at the beginning of the study and at week 36.
- Only the study participants with at least 70% valid readings on ambulatory monitoring and a minimum of 20 daytime and seven nighttime readings were included in the data analyses. This was 494 out of 600 initial participants.
- 69% of study participants self-identified as female, and 31% self-identified as male. 66.8% self-identified as white adults, 11.8% self-identified as Black adults and 25% self-identified as Hispanic ethnicity.
- The average age of the participants was 45.5 years, and their average BMI was 37.4 kg/m², which meets the criteria for obesity (obesity is BMI≥30). People with obesity have an increased risk of high blood pressure, heart disease, stroke and Type 2 diabetes, as well as other health conditions.
- Ambulatory blood pressure monitoring used in this study included blood pressure measurements every 30 minutes during the day and every hour at night, providing a more comprehensive assessment of blood pressure than in office or daily home blood pressure measurements. For ambulatory blood pressure monitoring, study participants wore a blood pressure monitoring device for a 24- to 27-hour period that measured blood pressure throughout waking and sleeping hours. Ambulatory blood pressure monitoring was conducted when participants first began taking tirzepatide at the start of the study and after 36 weeks of being enrolled in the study.
The 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults classifies hypertension, or high blood pressure, as having top and bottom blood pressure measures greater than or equal to 130/80 mm Hg.

Study limitations include that it was only conducted in a subset of the original 2,539 SURMOUNT-1 participants; the ambulatory blood pressure monitoring was only measured at two points in the study -; baseline and at 36 weeks; and measurements were only taken once per hour at night to minimize the burden on study participants. In addition, changes in food intake and 24-hour urine sodium excretion were not assessed, meaning the contribution of dietary modifications including salt intake or other changes that may help to reduce blood pressure are unknown and cannot be estimated.

“Overall, these data are encouraging that novel weight-loss medications are effective at reducing body weight and they are also effective at improving many of the cardiometabolic complications of obesity including hypertension, Type 2 diabetes and dyslipidemia, among others. While the impact of each of these beneficial effects is individually important, many of these obesity-related complications act synergistically to increase the risk of cardiovascular disease. Thus, strategies that mitigate multiple obesity-related complications may reduce the risk of cardiovascular events,” said Michael E. Hall, M.D., M.S., FAHA, chair of the writing group for the Association’s 2021 scientific statement on weight-loss strategies for prevention and treatment of hypertension and chair of the department of medicine at the University of Mississippi Medical Center in Jackson, Mississippi.

Additional studies will be necessary to determine the long-term impact on cardiovascular events such as heart attack and heart failure. Also, studies are needed to investigate what happens to blood pressure when medications like tirzepatide are discontinued – does the blood pressure rebound and go back up, or does it remain lowered?”

Michael E. Hall, M.D., M.S., FAHA, chair of the writing group

Co-authors and disclosures are listed in the manuscript. The study was funded by Eli Lilly and Company, the manufacturer of tirzepatide.

Source:

American Heart Association

Journal reference:

de Lemos, J. A., et al. (2024) Tirzepatide Reduces 24-Hour Ambulatory Blood Pressure in Adults With Body Mass Index ≥27 kg/m2: SURMOUNT-1 Ambulatory Blood Pressure Monitoring Substudy. Hypertension. doi.org/10.1161/HYPERTENSIONAHA.123.22022.
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February 5, 2024
Over 80% of semaglutide users achieve significant weight loss after 12 months, study finds

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In a recent study published in the International Journal of Obesity, researchers assessed the effectiveness of semaglutide dosages between 0.25 and 2.4 mg in overweight or obese people for up to one year.

Specifically, they assessed whether its use was safe and improved weight loss, metabolic, and comorbidity outcomes, including 10-year atherosclerotic cardiovascular disease [ASCVD] risk.

Study: Weight loss and cardiovascular disease risk outcomes of semaglutide: a one-year multicentered study. Image Credit: myskin/Shutterstock.com

Background

Obesity affects around 650 million adults globally, which has increased the burden of associated comorbidities, resulting in substantial morbidity and mortality.

Anti-obesity medications (AOMs) in conjunction with lifestyle modifications have consistently shown superior weight loss outcomes than lifestyle-targeted interventions alone.

For instance, randomized clinical trials (RCTs) on semaglutide, a Food and Drug Administration (FDA)-approved AOM, have shown superior weight loss outcomes for semaglutide than other AOMs.

Yet, only some real-world studies have assessed outcomes of semaglutide use over more than six months, limiting its clinical use.

About the study

The present retrospective study was conducted across all Mayo Clinic Hospitals in Florida, Minnesota, and Arizona in the US among patients with BMI ≥ 27 kg/m² who were prescribed weekly subcutaneous semaglutide injections between January 1, 2021, and January 15, 2023, for weight loss.

They obtained their metabolic, clinical, and laboratory data at baseline, three, six, nine-, and 12-month follow-ups. The prescribed doses of semaglutide were 0.25, 0.5, 1, 1.7, 2, or 2.4 mg.

In-person and virtual visits and physician-patient communication through electronic medical records (EMR) enabled data collection within 30 days of these time points.

Data collected was weight using calibrated scales, laboratory results for fasting blood glucose [FBG], lipid panel, glycosylated hemoglobin [HbA1c], blood pressure [BP] readings, and liver function tests [LFTs].

The team also assessed all obesity comorbidities, type-2 diabetes mellitus (T2DM), CVD, dyslipidemia, gastroesophageal reflux disease (GERD), non-alcoholic fatty liver disease (NAFLD), and obstructive sleep apnea (OSA), depression/anxiety, and their medications taken at baseline and last follow-up.

In addition, they documented side effects associated with semaglutide use and the number of visits with bariatric psychologists/dietitians.

This study’s primary endpoint was total body weight loss percentage (TBWL%) 12 months after the semaglutide start date.

Secondary endpoints were the percentage of patients attaining ≥5, 10, 15, and 20% weight loss and improvements in metabolic, cardiovascular, and comorbidities after 12 months of follow-up.

The statistical analyses involved a matched paired t-test to analyze the primary endpoint.

In addition, the team used a multivariate logistic regression model to determine weight loss post-bariatric psychologist/dietician visits accounting for T2DM status and setting the statistical significance of 2-sided P at <0.05.

Results

A total of 1,023 patients received semaglutide prescriptions for obesity. However, this analysis encompassed 304 patients, of which 73% were female and 93% were of White ethnicity.

The mean age of the included participants was 48.8 years, and they had a mean BMI of 40.9 kg/m2.

Patients achieved a TBWL of 5.7% at three, 9.7% at six, 12.7% at nine, and 13.4% at 12 months, with 22% of patients achieving weight loss of ≥20%.

At 12 months, patients without T2DM achieved a higher TBWL than patients without T2DM (16.9 vs. 9.9).

Likewise, patients on higher doses of semaglutide achieved a higher TBWL than patients taking lower doses at all time points.

Furthermore, patients with obesity experienced significant improvements in metabolic, lipid profile, blood pressure, liver function tests, and CVD outcomes.

Notably, 10-year ASCVD risk declined in patients with no history of CVD at one-year follow-up: 8.% to 6.7%.

Even though more than 50% of patients experienced side effects, mainly gastrointestinal symptoms, it required stopping semaglutide use or dose mitigation in only ~16% of the patients, showing that this drug is well-tolerated, which is crucial for chronic weight management.

Conclusions

Overall, semaglutide administration resulted in notable improvement in obesity, metabolic, and CVD risk outcomes among obese patients in a clinical setting.

Future trials should evaluate body weight changes over longer follow-up periods after stopping this medication.

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February 5, 2024
Ramadan fasting linked to favorable metabolic changes and reduced chronic disease risk
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In a recent study published in The American Journal of Clinical Nutrition, researchers carried out a metabolomics investigation to elucidate the impacts of Ramadan fasting on health and metabolism. Their study group comprised 72 participants who provided blood shortly before and after Ramadan fasting, based on which researchers generated metabolic scores. Study findings, obtained by comparing participants’ metabolic scores against those maintained by the UK Biobank, reveal that Ramadan fasting significantly reduced the risks of lung, colorectal, and breast cancers.

Study: Metabolomics of Ramadan fasting and associated risk of chronic diseases. Image Credit: Odua Images / Shutterstock

Can depriving your body of food make you healthier?

Fasting, the intentional abstention from consuming food and sometimes liquids, is practiced for clinical, religious, political, and fitness reasons, the latter of which is rapidly growing in popularity. Reports reveal that globally, many health-conscious individuals are gravitating toward ‘time-restricted fasting,’ an approach that restricts daily eating to a predetermined period each day (usually six to eight hours). Popularized by the term’ intermittent fasting,’ this trend promises general health improvements, weight loss, and fitness benefits.

Unfortunately, apart from observational evidence for weight loss, comprehensive metabolic and cohort-based studies into the other benefits of time-restricted fasting remain lacking. Ramadan, the Muslim month of fasting, reflection, prayer, and community, shares every trait of time-restricted fasting except its intent (Ramadan is religious fasting). This provides a ‘natural experiment’ to quantify the positive or negative impacts of time-restricted fasting.

Two previous works have investigated the impacts of Ramadan fasting on health. However, these studies were small-scale (n = 11, 25) and used dated analytical tools focused on overweight and obese individuals not representative of the fitness-oriented. This presents the need for an updated study using the latest metabolomics techniques and a larger, more generalized sample cohort, the results of which will inform the billions of Muslims and health-minded people worldwide.

About the study

In the present study, researchers recorded the metabolomics alterations following Ramadan fasting. Their study cohort was the London Ramadan Study (LORANS), an observational cohort comprising 140 Muslims who observe the Ramadan fast. Study data collection included demographic data, medical records, and two blood samples provided a few days before and a few days following initiation of the fast. Additionally, blood pressure and body composition were recorded during routine blood collection.

Study inclusion criteria comprised age (above 18 years), intended duration of fast (20 days or more), and completed data records. Pregnant women were excluded from the study. Following exclusions due to unmet criteria requirements, 72 participants were included for data analyses, all providing written informed consent to participate in the study.

Blood samples were processed to separate and isolate the plasma, which in turn was subjected to high-throughput Nuclear Magnetic Resonance (NMR) spectroscopy using the Nightingale platform. The Nightingale platform was chosen due to its ability to identify and quantify 169 lipids and metabolites. It was also selected because the United Kingdom’s (UK) Biobank dataset includes Nightingale platform readings. The UK Biobank is a country-wide large-cohort prospective study comprising 500,000 English citizens representative of the nation.

Linear mixed-effects models were used to compare NMR readings from blood samples provided before and after fasting, allowing a one-to-one comparison of the metabolite changes arising as outcomes of the fasting process. Additionally, UK Biobank Nightingale platform metabolite readings were used to compute metabolic risk scores for common chronic diseases, including cancers and cardiometabolic disorders. These values were then applied to NMR readings from this study to measure the relative change in chronic disease risk as a consequence of Ramadan (and, by extension, intermittent) fasting.

Study findings

Demographic analyses revealed that the mean age of the 72-strong study cohort was 45.7 years, 48.6% (n = 35) of whom were male. Body assessments during blood collection visits showed that, on average, participants lost 1.7 kg and 1.1% of their body fat in the two to three weeks between measurements. Nightingale platform analyses show that of the 169 measured metabolites, 14 were observed to change significantly when comparing blood collections.

These included one inflammation marker, one amino acid, two glycolysis-related metabolites, two ketone bodies, two triglycerides, and six lipoprotein subclasses. The most significant differences before/after Ramadan were observed for lactate (β = -0.31, P <0.001), acetate (β= -0.22, P <0.001), tyrosine (β= – 0.10, P=0.019) (all inverse) and acetone (β= 0.10, P=0.019) (direct).

For establishing the metabolic risk scores, baseline characteristics of 117,981 UK Biobank participants were used to establish seven scores, including diabetes (using 46 metabolites), coronary heart disease (16), hypertension (25), renal failure (12), lung cancer (nine), colorectal cancer (two), and breast cancer (one). Applying these scores to present study participants reveals that the relative risk of lung, colorectal, and breast cancers decreased by 9.6%, 2.4%, and 1.1%, respectively. In contrast, the other measured outcomes observed no changes in metabolic risk scores.

Conclusions

The present study uses Ramadan fasting as a natural experiment to investigate the effects of time-restricted fasting on people’s health and chronic illness risk. It used cutting-edge, high-throughput NRM spectroscopy via the Nightingale platform to compute chronic disease metabolite risk scores.

When applied to the 72 included study participants, the metabolic risk scores highlight the beneficial role of Ramadan fasting in reducing the risk of certain cancers such as lung (-9.6%), colorectal (-2.4%), and breast (-1.1%), while having no measurable effects on cardiovascular disease risk.

Ramadan fasting is associated with short-term favorable changes in the metabolic profile concerning the risk of some chronic diseases. These findings should be further investigated in future, larger studies of longer follow-up with clinical outcomes.
Journal reference:

Al-Jafar, R., Pinto, R. C., Elliott, P., Tsilidis, K. K., & Dehghan, A. (2024). Metabolomics of Ramadan fasting and associated risk of chronic diseases. The American Journal of Clinical Nutrition, DOI – 10.1016/j.ajcnut.2024.01.019, https://www.sciencedirect.com/science/article/pii/S000291652400056X
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February 5, 2024
Breakthrough obesity treatments on the horizon, rivaling surgery’s success

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In a recent study published in the International Journal of Obesity, researchers discussed the pipeline of obesity pharmacotherapies.

Obesity is a chronic disease affecting about 650 million individuals worldwide. It increases the risk of several metabolic complications, including cardiovascular disease and type 2 diabetes (T2D). Lifestyle interventions form the core of obesity management. Still, the average weight loss (WL) is ≤ 10%, even with the most intensive interventions.

Moreover, weight maintenance is challenging as weight regain occurs over time. While 5% to 10% WL is clinically beneficial, higher WL is required to improve or attain remission of obesity complications. Furthermore, bariatric surgery can offer up to 30% WL and longer-term weight maintenance; nevertheless, people may not opt for bariatric surgery due to perceived postoperative risks.

Understanding the role of entero-pancreatic hormones resulted in the development of glucagon-like peptide (GLP)-1 receptor agonists (RAs) for obesity and T2D treatment. Semaglutide is the latest GLP-1 RA approved for obesity, which can result in 15% to 17% mean WL. Nonetheless, a significant difference exists between WL achieved through obesity pharmacotherapies and bariatric surgery.

Further, current GLP-1 RAs for obesity are injectables, which some people may not consider. However, oral RAs are being developed to increase acceptance and adherence. Besides, a pipeline of pharmacotherapies based on entero-pancreatic hormones is being developed to enhance or complement GLP-1 RAs. In the present study, the authors discussed the pipeline of obesity pharmacotherapies.

Study: What is the pipeline for future medications for obesity? Image Credit: Suzanne Tucker / Shutterstock

GLP-1 RAs

Subcutaneous semaglutide (2.4 mg) and liraglutide (3 mg) have been approved for obesity management. A higher semaglutide dose (7.2 mg) is being evaluated in a phase 3 trial. Because people may be reluctant to use injectables, oral semaglutide has been introduced and approved for T2D, with the 14 mg dose improving hemoglobin A1c (HbA1c) levels and WL.

A phase 3 trial evaluated the efficacy and safety of a 50 mg oral dose of semaglutide in non-T2D obese subjects over 68 weeks. The trial revealed that semaglutide recipients achieved over 17% WL while placebo subjects attained < 2% WL. In a different trial on T2D subjects, the 50 mg semaglutide dose resulted in approximately 10% WL compared to 5.4% WL with the 14 mg dose.

Danuglipron is a non-peptide, G protein-based, oral GLP-1 RA. A phase 2b investigation among obese subjects showed that 40 mg to 200 mg doses of danuglipron resulted in over 11% WL after 32 weeks. Orforglipron is another non-peptide, oral GLP-1 RA, which is being evaluated for T2D and obesity management.

In obese subjects, 36-week orforglipron treatment led to WL of ≤ 14.7% and improvements in cardiometabolic risk factors. Likewise, in T2D patients, nearly half of the participants attained 10% or higher WL after a 26-week orforglipron treatment in a phase 2 trial. Currently, several phase 3 trials on orforglipron and oral semaglutide are underway for different populations.

GLP-1 glucagon like peptide-1, GIP glucose-dependent insulinotropic polypeptide, PYY peptide YY, *data mainly from animal studies.

Entero-pancreatic hormones and their combinations for obesity management

Multiple entero-pancreatic hormones are currently evaluated alone or in combination with GLP-1 RAs to augment or complement the effects of GLP-1 agonism on weight and metabolism. Jejunal K-cells secrete glucose-dependent insulinotropic peptide (GIP) in response to food intake. GIP stimulates insulin release and increases lipogenesis, glucagon secretion, and lipid buffering capacity.

Animal studies suggest an anorexigenic action of GIP receptor agonism. A phase 1 trial recently showed that repeated doses of long-acting GIP RA caused a modest WL in T2D subjects. Tirzepatide is an unimolecular subcutaneous dual (GIP and GLP-1) RA with comparable affinity to the GIP receptor but lower GLP-1 receptor affinity.

A phase 3 study investigated the efficacy and safety of tirzepatide for obesity, and it has now been approved for chronic weight management. Various trials are evaluating the effectiveness and safety of tirzepatide in ameliorating cardiometabolic complications. Further, several injectable or oral GIP/GLP-1 RAs are in the early phases of development.

Preliminary findings from rodent studies indicated a synergistic role of dual glucagon and GLP-1 agonism in reducing food intake. As such, numerous glucagon/GLP-1 co-agonists have been developed. Notwithstanding the promising results of glucagon/GLP-1 co-agonism in experimental studies, the efficacy and tolerability of the co-agonists have been heterogeneous in obese subjects.

A triple agonist targeting glucagon, GIP, and GLP-1 could result in superior WL and glycemic control than dual agonists. For instance, retatrutide is a triple agonist and has been shown to improve WL and glucose profile in preclinical models relative to tirzepatide through reduced calorie intake and elevated energy expenditure. A phase 2 study in non-T2D obese individuals reported dose-dependent WL following 48-week treatment with varying doses of retatrutide.

Concluding remarks

Taken together, a new era has commenced for obesity treatment where combinations of entero-pancreatic hormones can reach the WL efficacy of bariatric surgery. Besides tirzepatide, the dual agonist approved for chronic management, various dual and triple agonists are evaluated in phase 3 trials.

The multitude of obesity treatment options will enable tailored therapies based on individuals’ preferences, treatment responses, and comorbidities. Overall, obesity pharmacotherapies represent a rapidly growing field, and research on efficacy, safety, and cost-effectiveness will inform their place in therapeutic options for obesity and related complications.

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February 4, 2024
How self-monitoring and motivation fuel online weight loss success

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A recent BMC Public Health study analyzes self-monitoring data from Chinese adults who participated in a group weight loss intervention using a mixed-methods approach.

Study: Why more successful? An analysis of participants’ self-monitoring data in an online weight loss intervention. Image Credit: Ground Picture / Shutterstock.com

Background

According to the World Health Organization (WHO), over 1.9 billion adults were overweight in 2016. This global public health problem has reached alarming proportions in China, which significantly increases the risks of several diseases, including cancer, diabetes, and cardiovascular diseases.

Self-monitoring, which enhances self-awareness, promotes desired behaviors, and reduces unwarranted behaviors, can be achieved through setting specific targets and logging progress. Changes in body weight, exercise, and dietary intake are regularly monitored by participants of weight loss interventions. In fact, obese individuals who periodically monitor their diet and body weight have experienced more beneficial responses to interventions.

Researchers have both quantitatively and qualitatively analyzed the self-monitoring behaviors of dieters; however, few have utilized a mixed-methods approach for this purpose. Notable advantages of the mixed-methods approach include its ability to elucidate the association between weight loss and different self-monitoring indicators and reduce bias to ultimately develop reliable insights into self-monitoring.

About the study

Self-monitoring data from 61 Chinese adults who participated in a five-week online weight loss intervention group were analyzed in the current study. In addition to providing information on their weight loss motivation and body mass index (BMI) values, the study participants also engaged in daily quantitative monitoring, which included parameters like caloric intake and sedentary behavior, as well as qualitative self-monitoring, which involved a daily log of weight loss progress.

A scoring rule assessed the timeliness of the data. A one-way repeated measurement ANOVA was used to analyze the dynamics of self-monitoring indicators.

Regression and correlation analyses were performed to explore the relationship between weight change, self-monitoring indicators, and baseline data. Participants were grouped into three categories based on their weight loss outcomes, and their qualitative data was assessed using content analysis.

Key findings

Some fluctuation in self-monitoring data was observed throughout the intervention. Furthermore, some baseline characteristics of participants and self-monitoring behaviors were positively associated with their final weight loss outcomes. Across the weight loss categories, heterogeneity in qualitative self-monitoring data was observed.

During the weight loss process, a gradual decrease in caloric intake was observed, thus suggesting the learning behavior among participants. During the last week, participants exhibited some variation in commitment levels, which led to concerns about a rebound in caloric intake.

Weight loss satisfaction was highest in the first week and gradually declined. This decline in satisfaction was consistent with their weight loss, highlighting the link between effort and outcome.

Weight loss motivation, baseline BMI, and timeliness of daily self-monitoring data completion predicted final weight loss. The relationship between weight loss, daily physical activity expenditure, and daily caloric intake was insignificant. Furthermore, no significant relationship was observed between weight loss and daily mood.

The qualitative analysis of participants’ daily logs revealed four categories: eating behavior, weight loss awareness, physical activity, and perception of change, the latter of which was most frequently mentioned. This was followed by the mention of weight loss awareness, eating behavior, and physical activity.

Inconsistencies were noted in the probability distribution of participants’ daily log frequencies. Poor and moderate weight loss groups reported lower observed frequencies across all four categories than the excellent group. The excellent group reported a higher frequency of adjustments in eating habits, self-awareness, disadvantages, and demonstrating greater patience.

Conclusions

An inconsistent pattern in the self-monitoring behavior among individuals undergoing a group weight loss intervention was observed. More specifically, a higher level of self-monitoring was identified during the initial weeks of weight loss, followed by a slow decline.

More significant weight loss was attained by individuals with higher levels of motivation, higher baseline BMI, and those who regularly self-monitored. Furthermore, more detailed and frequent content was reported in the texts submitted by successful participants.

These findings imply that weight loss motivation and adherence to self-monitoring should be emphasized. The use of digital technologies could be beneficial, as they could facilitate greater weight loss awareness and promote healthy dietary habits.

In the future, more studies with larger sample sizes and precise measurement tools are needed to evaluate daily calorie expenditure and intake.

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February 2, 2024
Sleeve gastrectomy vs. Roux-en-Y gastric bypass

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A recent study published in JAMA Network Open evaluates the differences in perioperative outcomes between laparoscopic sleeve gastrectomy (SG) and laparoscopic Roux-en-Y gastric bypass (RYGB).

Study: Comparison of Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass: A Randomized Clinical Trial. Image Credit: Donenko Oleksii / Shutterstock.com

Background

The worldwide prevalence of obesity has increased substantially, with many studies indicating that this metabolic disorder is associated with significant mortality. Individuals with severe obesity may undergo metabolic and bariatric surgery, which is otherwise known as weight loss surgery, for weight management.

Although SG and RYGB are the most commonly performed surgical bariatric procedures, no studies have compared their safety and effectiveness. Until 2017, the most widely performed bariatric surgical procedure was RYGB in Sweden, until it ultimately shifted to SG.

RYGB has been associated with providing sustained weight loss and improvements in overweight-related comorbidities; however, this procedure is associated with an increased risk of abdominal pain, small bowel obstruction, nutritional deficiencies, alcohol use disorder, and post-bariatric hypoglycemia

European randomized clinical trials have compared SG and RYGB and revealed no significant differences in weight loss and resolution of comorbidities between the two procedures. Although diabetic patients who underwent RYGB exhibited better glucose control than those subjected to SG, these findings are based on limited-size clinical trials.

About the study

The current randomized and large-scale clinical trial compared the effectiveness of SG and RYGB in weight loss and risk to adverse events to determine which weight reduction surgical technique is more efficient. This study is extremely important due to the sudden increase in SG procedures in Sweden and Norway.

Perioperative outcomes of SG and RYGB, based on a large Swedish and Norwegian randomized clinical trial, were presented. A previously published Bypass Equipoise Sleeve Trial (BEST) methodology was followed, which was a multicenter randomized clinical trial that assessed the five-year outcomes of SG and RYGB.

Perioperative outcomes were measured between zero and 30 days of SG and RYGB, along with 90-day mortality. The study cohort included individuals 18 and older with a body mass index (BMI) between 35 and 50.

All study participants were recommended bariatric surgery. Participants with inflammatory bowel disease, uncontrolled psychiatric disease, moderate to severe gastroesophageal reflux disease, under-substance use, and those with a history of major upper gastrointestinal tract surgery were excluded. Eligible participants were randomly selected for SG or RYGB.

Study findings

A total of 878 and 857 patients underwent SG and RYGB, respectively, in twenty-three hospitals. The study cohort consisted of 74% females and 26% males, and their average age was 42.9 years, with a mean BMI of 40.8.

A low rate of perioperative complications was observed in both groups without statistical significance. Although aSG was associated with lower perioperative risk than RYGB, this was not considered clinically relevant due to the existence of other comorbid factors and differential long-term weight control efforts.

A higher number of serious adverse events within 30 days of the procedure was observed in the RYGB group in comparison to the SG group. In randomized studies, a more significant risk difference between groups could be due to selection bias, as healthier patients are more likely to undergo SG.

Contradictory study outcomes are also affected by the nature of the cohort. For example, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) study included patients with higher BMI and comorbidities than BEST. Therefore, MBSAQIP was associated with more complicated surgical procedures than BEST.

The BEST data reflects the possibility that a surgical community with a wider experience of performing RYGB can swiftly shift to SG with low complication rates. However, the possibility of an opposite transition must be reviewed.

As compared to previous assessments on perioperative complications after RYGB, the current study observed small bowel obstruction to be the most common perioperative complication. A higher incidence of small bowel obstruction after RYGB could be linked with the Lönroth surgical technique for RYGB.

The operating time between RYGB and SG was compared, in which a greater operating time was associated with RYGB, which could be due to the greater complexity of this surgical procedure. In both SG and RYGB, the length of post-operative hospitalization was one day after surgery.

Conclusions

The current randomized and large-scale observational study assessed the outcomes of SG and RYGB in individuals with a BMI of 35 to 50. Both surgical procedures were associated with low and insignificantly different perioperative morbidity. The study highlighted that perioperative risk should not be considered a criterion for selecting between SG and RYGB procedures.

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February 2, 2024