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Tag: Blood Sugar

  • Red light therapy shown to significantly reduce blood sugar spikes, study finds

    Red light therapy shown to significantly reduce blood sugar spikes, study finds

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    In a recent study published in the Journal of Biophotonics, scientists examined whether photobiomodulation of healthy subjects using red light of 670 nm wavelength impacted the circulating glucose levels in the plasma, using oral glucose tolerance tests.

    Study: Light stimulation of mitochondria reduces blood glucose levels. Image Credit: AlteredR/Shutterstock.comStudy: Light stimulation of mitochondria reduces blood glucose levels. Image Credit: AlteredR/Shutterstock.com

    Background

    Mitochondria are the organelles that carry out cellular respiration, using glucose and oxygen to produce adenosine triphosphate or ATP, the energy currency. The ability of the mitochondria to produce ATP reduces naturally with age and due to diseases.

    However, studies have found that the production of ATP can be increased through photobiomodulation using light in the visible and near-infrared ranges, between 650 nm and 900 nm.

    Photobiomodulation is also known to decrease reactive oxygen species levels, and this ability is believed to be conserved across species in the animal kingdom.

    Cytochrome C oxidase, which is part of the electron transport chain in the mitochondrial membrane, absorbs these longer wavelengths of light, increasing the membrane potential and production of ATP.

    Research has shown that photobiomodulation has brought about significant increases in regions of the body undergoing high levels of metabolic activity, such as the retina and the central nervous system.

    The increased ATP production could also increase the uptake of glucose, which might be evident in changes in the plasma glucose levels.

    About the study

    In the present study, the researchers used a standard glucose tolerance test to determine whether photobiomodulation using 670 nm light decreased blood glucose levels in healthy human subjects.

    The study included 30 healthy participants with no known medical conditions, half of whom underwent photobiomodulation with 670 nm light, and the other half were in the placebo group with no light.

    All the participants underwent an oral glucose tolerance test at the onset of the study, where they consumed 75 g of glucose dissolved in 150 mL of water, and finger prick blood samples were used to record the blood glucose levels.

    A second oral glucose tolerance test was administered after a week when the participants were administered the placebo or the intervention.

    About 45 minutes before the second oral glucose tolerance test was administered, the participants in the intervention group were exposed to 670 nm light for 15 minutes, while those in the placebo group were identically positioned but not exposed to the 670 nm light.

    The oral glucose tolerance tests were administered only after ensuring that the participants had fasted overnight.

    After consuming glucose dissolved in water, blood glucose concentrations and the end-tidal carbon dioxide (EtCO2) partial pressure were recorded every quarter of an hour for two hours when the participants were at rest.

    The 670 nm light exposure was directed at an 800 cm2 region in the upper back, using light-emitting diodes with a shield to prevent light leakage.

    The glucose tolerance test results were compared between the participants in the intervention and placebo groups.

    Additionally, participants in the intervention group were compared to each other, and similar comparisons were made within the placebo group for paired-participant analysis to account for individual variations.

    Results

    The results showed that exposure to 670 nm of light over 15 minutes resulted in a 27.7% decrease in glucose levels averaged over two hours.

    Additionally, a 7.5% decrease was also observed in maximum glucose spiking within the intervention group, and a 12.1% difference in peak glucose levels was seen between the placebo and intervention groups.

    The paired-participant analysis within the placebo group also showed no difference in the blood glucose levels between the two measurements.

    The impact of the light exposure was significant after approximately an hour and a half of local light exposure alone. The impact of this local light exposure on plasma glucose levels indicates an abscopal effect, where mitochondria in distal organs are also impacted.

    The researchers also discussed the potential mechanisms through which local light exposure could have such widespread impact, including the role of circulating cytokines and cell-free mitochondria in the blood that are competent to conduct cellular respiration.

    Conclusions

    To summarize, the findings showed that local exposure to 670 nm light for 15 minutes significantly reduced plasma and peak glucose levels.

    While these results have proven that longer wavelengths of light have a positive effect on mitochondrial function in healthy humans, the potential use of light exposure in helping regulate blood glucose levels in patients with diabetes needs to be explored.

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  • Exome sequencing unravels complex genetic diagnoses in growth disorders

    Exome sequencing unravels complex genetic diagnoses in growth disorders

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    In an article published in the Journal of Pediatrics, researchers based in Brazil describe the case of a nine-year-old boy admitted to hospital with multiple symptoms and overlapping conditions that made diagnosis difficult, such as short stature, thin tooth enamel (dental enamel hypoplasia), moderate mental deficiency, speech delay, asthma, mildly altered blood sugar, and a history of recurring infections in infancy. 

    The team used exome sequencing, in which only the protein-coding portion of the genome is analyzed, to look for genetic mutations, and found them in GCK and BCL11B. As a result, the diagnosis was monogenic diabetes and T-cell abnormality syndrome, both of which are rare diseases. Identification of the exact cause of the problem and the discovery of a blood sugar alteration significantly influenced their choice of treatment. 

    This is one of six cases involving syndromic growth disorders with multiple genetic diagnoses (two or more distinct genetic conditions in the same patient) described in the article, which concerns a study conducted by researchers at the University of São Paulo’s Medical School (FM-USP) with FAPESP’s support. 

    Exome sequencing is a very useful technology to reduce what we call the diagnostic odyssey – the long journey patients with rare or complex conditions have to undergo until they receive a proper diagnosis. Ten years ago, private labs charged BRL 10,000. The price has now fallen to BRL 4,000 [about USD 800]. That’s still a lot of money for a test, but it has proved essential to accurate diagnosis and treatment in cases of this kind.”


    Alexander Augusto de Lima Jorge, last author of the article

    The team sequenced the exomes of 115 patients with syndromic growth disorders that had hitherto unknown causes, diagnosing 63 on the basis of the genetic analysis; 9.5% of these had a multiple diagnosis, far more than in previous studies. 

    “The cases involved two or more rare monogenic conditions in the same patient. Such cases are very hard to diagnose, especially by clinical assessment alone. The study highlights the need to use broad genetic tests such as whole exome or whole genome sequencing for these patients as the only way to identify the rare diseases that explain such clusters of conditions,” Lima Jorge said. 

    There are numerous rare diseases, including growth disorders, so it is naturally difficult to identify many of them, he added. Between 5% and 10% of the world population is believed to have a rare disease. 

    Short stature or tall stature is not a diagnosis but a clinical finding. “Short stature may have an external cause, such as an infection or malnutrition. Even so, genetic factors will always be important to growth. In healthy children with short or tall stature as the only manifestation, there will probably be a polygenic basis [where stature is influenced by several genetic variants], but in syndromic growth disorders, in which short or tall stature is accompanied by other findings such as mental deficiency, deafness, autism spectrum disorder or malformation, an alteration in one or more genes is more likely as a justification for the complex phenotype involved,” Lima Jorge said. 

    In light of the results, the researchers advocate recognition of multiple genetic diagnoses as a possibility in complex cases of growth disorder, opening up novel prospects for treatment and genetic counseling for such patients, in place of the typical paradigm that calls for a single diagnosis to explain all findings. 

    In the article, the researchers state that the development of next-generation sequencing techniques such as whole exome or whole genome sequencing has made selecting a single gene as the candidate to explain a case unnecessary. This particular benefit has proved useful in the research environment to foster the discovery of novel disease-associated genes, to further the study of conditions with a high degree of genetic heterogeneity, and to help care for patients with complex syndromic conditions, where diagnoses cannot be obtained by traditional clinical and genetic methods. 

    Several challenges noted by Lima Jorge include the high cost of genetic tests and the fact that exome sequencing has a success rate of about 50% in the diagnosis of complex cases. In other words, about half the patients submitted to this kind of analysis will have to go on looking for a conclusive diagnosis.

    Source:

    São Paulo Research Foundation (FAPESP)

    Journal reference:

    Rezende, R. C., et al. (2024). Exome Sequencing Identifies Multiple Genetic Diagnoses in Children with Syndromic Growth Disorders. The Journal of Pediatrics. doi.org/10.1016/j.jpeds.2023.113841.

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  • Managing migraines and menopausal symptoms to reduce cardiovascular risks in middle-aged women

    Managing migraines and menopausal symptoms to reduce cardiovascular risks in middle-aged women

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    For middle-aged women plagued by migraines, or hot flashes and night sweats, another worry may linger in the backs of their minds: whether these experiences have set them up for a heart attack, a stroke or another cardiovascular crisis.

    After all, past research suggesting such a link during and after menopause has gotten a lot of attention.

    But a pair of new studies in the journal Menopause suggest that most of them don’t need to worry as much, especially if they don’t have both migraines and long-term hot flashes and night sweats.

    Instead, they should focus on tackling the other factors that can raise their cardiovascular risk by getting more sleep, exercise and healthy foods, quitting tobacco, and minding their blood pressure, blood sugar, cholesterol and weight.

    For women who have experienced both migraines and hot flashes or night sweats over many years, one of the new studies does suggest an extra level of cardiovascular risk. That makes heart disease and stroke prevention even more important in this group, says study leader Catherine Kim, M.D., M.P.H., of the University of Michigan.

    And for women currently in their 20s and 30s who experience migraines, the new research suggests that they might be heading for a higher risk of long-term menopause-related symptoms when they get older.

    Long-term study yields important insights

    Kim and her colleagues at Michigan Medicine, U-M’s academic medical center, published the new pair of studies based on an in-depth analysis of data from a long-term study of more than 1,900 women who volunteered to have regular physical exams and blood tests, and to take yearly health surveys, when they were in their late teens to early 30s.

    Those women, now in their 50s and 60s, have provided researchers with a priceless view of what factors shape health in the years leading up to menopause and beyond, through their continued participation in the CARDIA study.

    “The anxiety and dread that women with migraines and menopausal symptoms feel about cardiovascular risk is real – but these findings suggest that focusing on prevention, and correcting unhealthy habits and risk factors, could help most women,” said Kim, who is an associate professor of internal medicine at U-M and a primary care physician.

    “For the subgroup with both migraines and early persistent hot flashes and night sweats, and for those currently experiencing migraines in their early adulthood, these findings point to an added need to control risks, and address symptoms early,” she adds.

    Just over 30% of the middle-aged women in the study reported they had persistent hot flashes and night sweats, which together are called vasomotor symptoms or VMS because they relate to changes in the diameter of blood vessels.

    Of them, 23% had reported also having migraines. This was the only group for whom Kim and her colleagues found extra risk of stroke, heart attack or other cardiovascular events that couldn’t be explained by other risk factors that have long been known to be linked to cardiovascular problems.

    In addition to those with persistent vasomotor symptoms starting in their 40s or before, 43% of the women in the study had minimal levels of such symptoms in their 50s, and 27% experienced an increase in VMS over time into their 50s and early 60s.

    The latter two groups had no excess cardiovascular risk once their other risk factors were taken into account, whether or not they had migraines. Use of hormone-based birth control and estrogen to address medical issues did not affect this risk.

    Controlling destiny

    In the study of data from the same women in their earlier stages of life, the researchers found that the biggest factors in predicting which ones would go on to have persistent hot flashes and night sweats were having migraines, having depression, and smoking cigarettes, as well as being Black or having less than a high school education.

    These two studies, taken together, underscore that not all women have the same experiences as they grow older, and that many can control the risk factors that might raise their chances of heart disease and stroke later in life. In other words, women can do a lot to control their destiny when it comes to both menopause symptoms and cardiovascular diseases.”


    Catherine Kim, M.D., M.P.H., University of Michigan

    She notes that the American Heart Association calls these risk factors the “Essential 8” and offers guides for what women, men and even children and teens can do to address them.

    Evolving knowledge and treatment

    The long-term study that the two new findings come from was specifically designed to look at cardiovascular risks when it launched in the mid-1980s. CARDIA stands for Coronary Artery Risk Development in Young Adults.

    Back in the 80s, knowledge about the biology of blood vessels, down to the cellular and molecular level, was nowhere near where it is today. Both vasomotor symptoms in menopause and migraines have to do with blood vessel contraction and dilation.

    But decades of research has shown the microscopic impacts on blood vessels of years of smoking, poor sleep, poor eating habits and lack of activity, as well as a person’s genetic inheritance, life experiences and hormonal history.

    Newer injectable migraine medications called calcitonin gene-related peptide (CGRP) antagonists have reached the market in recent years.

    Using monoclonal antibodies, they target a key receptor on the surface of blood vessel cells to prevent migraines and cluster headaches. But they are expensive and not covered by insurance for all people with migraines.

    While the new study is based on data from years before these medications became available, Kim said she recommends them to her patients with persistent migraines, as well as working with them to understand what triggers their migraines and how to use other medications including pain relievers and antiseizure medications to prevent them.

    She also notes that the paper on future risk of persistent hot flashes and night sweats echoes the recent trend of using antidepressant medications to try to ease these menopause effects.

    Kim also says that evidence has grown about the importance of healthy sleep habits for reducing hot flashes, as well the short-term use of estradiol-based hormone therapy patches, which have not been shown to have a link to cardiovascular risk. And, she notes that research has not shown any over-the-counter supplement or herbal remedy to be effective, and that these are far less regulated than medications.

    Additional authors:

    Kim and Deborah Levine, M.D., M.P.H., senior author of the paper on cardiovascular risk, are both on the faculty in the Division of General Medicine, and members of the U-M Institute for Healthcare Policy and Innovation. Levine heads the Cognitive Health Services Research Program or COG-HSR. Other authors on this paper are Pamela J. Schreiner, Ph.D., of the University of Minnesota, Zhe Yin, M.S., formerly of IHPI, Rachael Whitney, Ph.D., lead statistician at COG-HSR; Stephen Sidney, MD, MPH, of Kaiser Permanente Northern California and Imo Ebong, M.D. of the University of California, Davis.

    Schreiner is the senior author of the paper on later persistent VMS risk in younger women. Other authors on that paper are U-M’s Abbi Lane, Ph.D.; Zhe Yin, M.S.; Hui Jiang, Ph.D. and Richard Auchus, M.D., Ph.D.; as well as Thanh-Huyen Vu M.D., Ph.D. of Northwestern University and Cora Lewis, M.D. of the University of Alabama.

    The study was funded by the National Heart, Lung and Blood Institute (HL169167), which also sponsors the CARDIA study.

    Source:

    Michigan Medicine – University of Michigan

    Journal reference:

    Kim, C., et al. (2024) Migraines, vasomotor symptoms, and cardiovascular disease in the Coronary Artery Risk Development in Young Adults study. Menopause. doi.org/10.1097/GME.0000000000002311.

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  • States target health insurers’ ‘prior authorization’ red tape

    States target health insurers’ ‘prior authorization’ red tape

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    Christopher Marks noticed an immediate improvement when his doctor prescribed him the Type 2 diabetes medication Mounjaro last year. The 40-year-old truck driver from Kansas City, Missouri, said his average blood sugar reading decreased significantly and that keeping it within target range took less insulin than before.

    But when his doctor followed the typical prescribing pattern and increased his dose of Mounjaro — a drug with a wholesale list price of more than $1,000 a month — Marks’ health insurer declined to pay for it.

    Marks had Cigna insurance that he purchased on the federal health insurance marketplace, healthcare.gov. After two appeals over a month and a half, Cigna agreed to cover the higher dose. A few months later, he said, when it was time to up his dose once more, he was denied again. By November, he decided it wasn’t worth sparring with Cigna anymore since the insurer was leaving the marketplace in Missouri at the start of this year. He decided to stay on the lower dose until his new insurance kicked in.

    “That is beyond frustrating. People shouldn’t have to be like, ‘It’s not worth the fight to get my medical treatment,’” Marks said.

    The process Marks encountered is called “prior authorization,” or sometimes “pre-certification,” a tool insurers say they use to rein in costs and protect patients from unnecessary or ineffective medical treatment. But the practice has prompted backlash from patients like Marks, as well as groups representing medical professionals and hospitals that say prior authorization can interfere with treatment, cause medical provider burnout, and increase administrative costs.

    In January, the Biden administration announced new rules to streamline the process for patients with certain health plans, after attempts stalled out in Congress, including a bill that passed the House in 2022. But states are considering prior authorization bills that go even further. Last year, lawmakers in 29 states and Washington, D.C., considered some 90 bills to limit prior authorization requirements, according to the American Medical Association, with notable victories in New Jersey and Washington, D.C. The physicians association expects more bills this year, many with provisions spelled out in model legislation the group drafted.

    In 2018, health insurers signed a consensus statement with various medical facility and provider groups that broadly laid out areas for improving the prior authorization process. But the lack of progress since then has shown the need for legislative action, said Jack Resneck Jr., past president of the AMA and a current trustee.

    “They have not lived up to their promises,” Resneck said.

    Resneck, a California dermatologist, emphasized pending bills in Indiana, Massachusetts, North Carolina, Oklahoma, and Wyoming that include several policies backed by the AMA, including quicker response times, requirements for public reporting of insurers’ prior authorization determinations, and programs to reduce the volume of requests, sometimes called “gold carding.” Legislation has come from both Democratic and Republican lawmakers, and some is bipartisan, as in Colorado.

    In Missouri, legislation introduced by Republican state Rep. Melanie Stinnett aims to establish one of those gold carding programs for treatment and prescriptions. Stinnett said she regularly was frustrated by prior authorization hurdles in her work as a speech pathologist before joining the legislature in 2023.

    “The stories all kind of look similar: It’s a big fight to get something done on the insurance side for approval,” Stinnett said. “Then sometimes, even after all of that fight, it feels like it may have not been worthwhile because some people then have a change at the beginning of the year with their insurance.”

    Under her bill, a medical provider’s prior authorization requests during a six-month evaluation period would be reviewed. After that period, providers whose requests were approved at least 90% of the time would be exempt from having to submit requests for the next six months. The exemptions would also apply to facilities that meet that threshold. Then, she said, they would need to continue meeting the threshold to keep the “luxury” of the exemption.

    Five states have passed some form of gold carding program: Louisiana, Michigan, Texas, Vermont, and West Virginia. The AMA is tracking active gold carding bills in 13 states, including Missouri.

    A 2022 survey of 26 health insurance plans conducted by the industry trade group AHIP found that just over half of those plans had used a gold carding program for medical services while about a fifth had done so for prescriptions. They gave mixed reviews: 23% said patient safety improved or stayed the same, while 20% said the practice increased costs without improving quality.

    The new federal prior authorization rules finalized by the Centers for Medicare & Medicaid Services stop short of gold carding and don’t address prior authorizations for prescription drugs, like Marks’ Mounjaro prescription. Beginning in 2026, the new rules establish response time frames and public reporting requirements — and ultimately will mandate an electronic process — for some insurers participating in federal programs, such as Medicare Advantage or the health insurance marketplace. Manual submissions accounted for 39% of prior authorization requests for prescriptions and 60% of those for medical services, according to the 2022 insurance survey.

    In Missouri, state and national organizations representing doctors, nurses, social workers, and hospitals, among others, back Stinnett’s bill. Opposition to the plan comes largely from pharmacy benefit managers and the insurance industry, including the company whose prior authorization process Marks navigated last year. A Cigna Healthcare executive submitted testimony saying the company’s experience showed gold card policies “increase inappropriate care and costs.”

    The St. Louis Area Business Health Coalition, which represents dozens of employers that purchase health insurance for employees, also opposes the bill. Members of the coalition include financial services firm Edward Jones, coal company Peabody Energy, and aviation giant Boeing, as well as several public school districts and the St. Louis city and county governments.

    Louise Probst, the coalition’s executive director, said the prior authorization process has issues but that the coalition would prefer that a solution come from insurers and providers rather than a new state law.

    “The reason I hate to see things just set in stone is that you lose the flexibility and the nuance that could be helpful to patients,” Probst said.

    On the other side of the state, Marks purchased insurance for this year on the federal marketplace from Blue Cross and Blue Shield of Kansas City. In January, his doctor re-prescribed the higher dose of Mounjaro that Cigna had declined to cover. A little over a week later, Marks said, his new insurance approved the higher dose “without any fuss.”

    Cigna spokesperson Justine Sessions said the company uses prior authorizations for popular drugs such as Mounjaro to help ensure patients get the right medications and dosages.

    “We strive to make authorizations quickly and correctly, but in Mr. Marks’ case, we fell short and we greatly regret the stress and frustration this caused,” she said. “We are reviewing this case and identifying opportunities for improvement to ensure this does not happen in the future.”

    Marks’ aim with this higher dose of Mounjaro is to get off his other diabetes medications. He particularly hopes to stop taking insulin, which for him requires multiple injections a day and carries a risk of dangerous complications from low blood sugar.

    “I don’t really use the word ‘life-changing,’ but it kind of is,” Marks said. “Getting off insulin would be great.”

    Do you have an experience with prior authorization you’d like to share? Click here to tell your story.




    Kaiser Health NewsThis article was reprinted from khn.org, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.

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  • UT Health San Antonio scientist receives $1.2 million to implement early intervention measures for pre-diabetes

    UT Health San Antonio scientist receives $1.2 million to implement early intervention measures for pre-diabetes

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    More than one out of three people have pre-diabetes, characterized by abnormal blood sugar levels not yet in the diabetes range – and yet associated with significant increases in eye, kidney and neuropathic diseases, and risk of cardiovascular death.

    Moreover, the number of people with the condition is expected to double by 2030, with prevalence substantially higher in minority populations, including Hispanics. Both pre-diabetes and diabetes are considered global epidemics.

    As pre-diabetes largely is underdiagnosed and undertreated, Carolina Solis-Herrera, MD, a physician-scientist, associate professor and chief of endocrinology at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) has received a first-of-its-kind, $1.2 million award from Baptist Health Foundation of San Antonio to implement early intervention measures for the condition. It will serve a significant unmet need in the community.

    The goal is to establish pioneering and affordable treatment regimens for early intervention and treatment of pre-diabetes and obesity, with emphasis in the Hispanic population, that later can be spread throughout our community by establishing pre-diabetes clinics and stopping the progression of diabetes.”

    Carolina Solis-Herrera, MD, physician-scientist, associate professor and chief of endocrinology at The University of Texas Health Science Center at San Antonio

    “Additionally,” she said, “using sophisticated imaging and molecular technology, we aim to identify novel therapeutic targets to treat these disorders as we work toward a cure.”

    “Baptist Health Foundation of San Antonio is honored and excited to be involved in Dr. Solis-Herrera’s work,” said Cody Knowlton, president and CEO of the foundation. “Diabetes is a pressing concern for so many people in our service area, and we pray that this study will have clear, impactful results that can improve the future health of our community.”

    What indicates pre-diabetes?

    Pre-diabetes is indicated by a “glycated hemoglobin blood test,” commonly known as an A1C test, that provides information on average levels of blood glucose, or blood sugar, over a previous two-to-three-month period. Results are reported as a percentage; the higher the percentage, the greater the risk of developing Type 2 diabetes, the most common form.

    An A1C level of 5.7% to 6.4% indicates pre-diabetes, with a level of 6.5% or more indicating diabetes. A combination of lifestyle changes and medication can lead to a long-term prevention of progression to Type 2 diabetes. As it is, however, more than half of patients with pre-diabetes will develop Type 2 diabetes in their lifetimes.

    More than 37 million Americans, or approximately one in 10, have Type 2 diabetes – and about one in five of those don’t know it. Diabetes is the main cause of blindness, amputation and dialysis worldwide, and in this population, cardiovascular events are the leading cause of death. The prevalence of Type 2 diabetes is significantly higher in Hispanics.

    But pre-diabetes itself is considered a serious health condition, even though blood sugar levels are not high enough to be Type 2 diabetes. More than 96 million Americans have pre-diabetes, and an estimated 80% of those are not diagnosed. And yet pre-diabetes patients have a significantly higher risk of cardiovascular disease and death.

    Risk factors for both pre-diabetes and Type 2 diabetes include obesity, sedentary lifestyle, family history and minority descent. More than 41% of Americans are classified as obese. And risk factors in San Antonio and South Texas are greater.

    More than 65% of the population of greater San Antonio is Hispanic, and the prevalence of pre-diabetes and Type 2 diabetes here is significantly higher than the rest of the country. Bexar County has the highest Type 2 diabetes age-adjusted mortality rate in Texas, and each year, the cost of diagnosed Type 2 diabetes statewide is approximately $25.6 billion.

    “Given the lack of early diagnosis and treatment, the cost of pre-diabetes and its complications is unknown, but can be expected to be much greater than with Type 2 diabetes,” Solis-Herrera said. “In addition, cost of treatment can be a barrier. Therefore, affordable alternatives are needed and will be identified through this study.”

    While multiple studies have explored available therapies for Type 2 diabetes, she says, only recently has there been significant attention paid to pre-diabetes.

    “Proactive detection and early intervention of pre-diabetes will significantly decrease the progression of diabetes, with a tremendously positive impact in our community,” Solis-Herrera said. “Moreover, by using state-of-the-art research technology, this study will be the first of its kind to utilize a combination of the latest pharmacological therapies and biomolecular tools, giving us a distinct advantage that will uniquely focus on our Hispanic population.”

    Source:

    University of Texas Health Science Center at San Antonio

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  • Reducing unnecessary testing or treatments in older patients

    Reducing unnecessary testing or treatments in older patients

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    When a doctor ordered a routine prostate screening for an 80-year-old man -; as doctors often do -; a dramatic yellow alert popped up on the electronic health record with dire warnings. 

    It flashed: “You are ordering a test that no guideline recommends. Screening with PSA can lead to harms from diagnostic and treatment procedures. If you proceed without a justification, the unnecessary test will be noted on the health record.” 

    This was the strategy Northwestern Medicine investigators tested to see if they could move the needle on the stubbornly persistent practice of ordering unnecessary screenings for older adults. Doctors got the message.

    The results, published Feb. 6 in Annals of Internal Medicine, found a significant decrease in screenings for prostate cancer and urinary tract infections. 

    After 18 months of delivering the alerts to 370 clinicians in 60 Northwestern Medicine clinics, unnecessary testing was reduced 9% in the PSA intervention group and 5.5% in the urine testing intervention group. There was, however, only a small change, in the overtreatment of blood sugar, which also can result in potential harm. Half of the physicians received the alerts, the other half did not. 

    To our knowledge, this is the first study to significantly reduce all of the unnecessary testing or treatments studied using point-of-care alerts. We believe that incorporating elements like a focus on potential harms, sharing social norms and promoting a sense of social accountability and reputational concerns led to the effectiveness of these messages.”


    Dr. Stephen Persell, lead investigator, professor of medicine at Northwestern University Feinberg School of Medicine and a Northwestern Medicine physician

    Several recent trials that attempted to reduce overuse of testing, using interventions delivered to clinicians through the electronic health record, have not been particularly successful at changing clinicians’ behavior, Persell noted. 

    “But if messages clinicians find compelling can be delivered by electronic health records at the time clinicians place their orders, this could be a straightforward way to improve care and could be applied across large health systems easily,” Persell said. 

    Harm from unnecessary screening and overtreatment

    Screening a man 76 years or older for prostate cancer may result in overtreatment that could cause him serious health problems than simply living with an indolent cancer.

    Even so, a man’s primary care physician will often obtain a PSA test to screen for prostate cancer. Ditto for women 65 and older being tested for urinary tract infections without any symptoms. Doctors also overtreat diabetes with hypoglycemic agents in patients aged 75 years and older.

    The overuse of low-value screenings and unnecessary care remains a problem in American health care, particularly for older adults. 

    “These are screening practices people have adopted without good evidence,” Persell said. 

    “If a man is not going to live another 10 or 15 years due to his age, you won’t save his life from prostate cancer by screening him, but you will subject him to the potential harms of treatment,” said Persell, also director of the Center for Primary Care Innovation at Feinberg. The treatment may lead to surgery or radiation treatment that can cause urinary incontinence or urinary symptoms, impair sexual function or cause rectal bleeding. 

    “What’s right for a 68-year-old man might not be right for one who is 75 or 85 years old,” Persell said. 

    Harm can also result from testing women 65 and older for urinary tract infections, if they are not experiencing any symptoms.

    “These asymptomatic urinary tract infections are common in older women, but there is no evidence that you can improve a woman’s health with antibiotics,” Persell said. Antibiotics, however, can cause allergic reactions, diarrhea and antibiotic resistance, which could make bacterial infections harder to treat in the future.

    In addition, treating blood sugar to very low levels in older adults with drugs like insulin or sulfonylureas puts older patients at risk for dangerous low blood sugar events. 

    But doctors and patients resist change in blood sugar interventions. “We have taught patients to strive to control their blood sugar, even when it gets to a point when it’s safer to have slightly less controlled blood sugar,” Persell said. “It’s hard to convince patients and doctors to change their goals.”

    The next step in the research and other ongoing studies are testing whether similar approaches can be used to improve the quality of care in other areas where treatments may be overused such as opioids, sleeping pills and drug combinations that may cause harm. 

    Other authors include Lucia C. Petito, Ji Young Lee, Daniella Meeker, Jason N. Doctor, Noah J. Goldstein, Craig R. Fox, Theresa A. Rowe, Dr. Jeffrey A. Linder, Ryan Chmiel, Yaw Amofa Peprah and Tiffany Brown.

    The title of the article is “Reducing Care Overuse in Older Patients Using Professional Norms and Accountability.”

    The research was supported by National Institute on Aging of the National Institutes of Health award R33AG057383.

    Source:

    Journal reference:

    Persell, S. D., et al. (2024). Reducing Care Overuse in Older Patients Using Professional Norms and Accountability. Annals of Internal Medicine. doi.org/10.7326/m23-2183.

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  • New weight loss drug may be an effective strategy for preventing or treating high blood pressure

    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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