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Are GLP-1 Receptor Agonists Safe for Children?

Tatyana Meshcheryakova December 11, 2024 No Comments

Weight loss medications like Ozempic and Wegovy are becoming increasingly popular, especially as alternatives to the traditional and often ineffective advice of “eat less and exercise more.” These drugs, known as GLP-1 receptor agonists, have gained favor among adults but are also becoming more widely used by children and teenagers (here’s a good rundown on their types, benefits and side effects).

Adolescent use of GLP-1 medications surges

A recent article published on the MedicalXPress website cites a CDC statistic that roughly one in five children in the U.S. is affected by obesity. And, according to a University of [BLOCKQUOTE] study, the use of GLP-1 medications among adolescents has surged, with over 30,000 young people aged 12 to 17 taking the drugs in 2023.

Are weight loss drugs safe for children under 12?

Doctors generally agree that addressing obesity early can prevent future health problems, but prescribing weight loss drugs to children brings its own set of challenges. Dr. Chris Straughn, a pediatrician in Dallas, explains that while research indicates that GLP-1 medications can be effective and safe for children and teens, the available studies only track their effects over a few years. As these drugs are relatively new, more time is needed to fully understand their long-term impact.

Wegovy, a version of Ozempic, is FDA-approved for children as young as 12, though it has not been approved for those younger than 12. There are ongoing studies on its use in younger children, and some research on Saxenda (a precursor to Wegovy) shows it can be effective for kids aged 6 to 12. This kind of research is promising for the potential use of GLP-1s in younger patients.

The study, which included 82 participants, found that when children discontinued Saxenda, their BMI began to increase once more. This suggests that to maintain the weight-related benefits as they grow, children may need to stay on the medication. The findings were presented Tuesday at the annual meeting of the European Association for the Study of Diabetes in Madrid and were also published in the New England Journal of Medicine.

Dr. Dan Cooper, a pediatric researcher at UC Irvine, agrees that GLP-1 medications can be useful in certain cases, such as when a child is already developing or has developed diabetes. However, he cautions that the risk-benefit balance is less clear in other children, especially since there is limited research on the long-term effects of GLP-1 use in growing bodies. Puberty is a critical period for bone, muscle, and brain development, and Cooper warns that altering a child’s energy balance during this time could have lasting consequences.

Dr. Cooper reminds parents not to feel ashamed if their child struggles with obesity or weight-related issues. He says,

No one should feel ashamed… Obesity is often driven by biology, and it’s not something to blame yourself or your child for.

The need for alternative solutions

As obesity rates continue to rise, many people are turning to prescription medications like Ozempic for weight loss. However, these drugs come with significant side effects, accessibility challenges, and high costs, highlighting the need for alternative solutions. We’ve discussed them before, including berberine and natural supplements.

A new natural treatment emerges

Researchers at the University of South Australia have developed a new, natural, food-grade treatment for obesity that not only helps reduce weight and improve metabolic health but allegedly does so without the negative side effects commonly associated with other medications.

The new treatment, called InuMCT microcapsules, is made from a combination of plant fiber (inulin) and MCT oils derived from coconut and palm kernel oils. This formulation helps reduce inflammation and improve key metabolic markers, such as blood glucose levels.

In a 21-day study, the InuMCT microcapsules demonstrated several significant benefits:

Weight reduction: The microcapsules led to a substantial decrease in weight gain caused by a typical western diet, which is high in fats and linked to obesity.
Blood sugar control: Blood sugar levels were reduced by 15%, an important factor in managing both obesity and diabetes.
Reduced inflammation: Inflammatory markers dropped by 78%, which is crucial, as inflammation is a major contributor to obesity and related diseases.
Liver health: Liver enzyme levels decreased by up to 47%, as high liver enzymes are often associated with poor diet and obesity.
Gut health: The microcapsules improved protective gut bacteria by 8.3-fold, supporting the gut lining and helping prevent conditions like “leaky gut syndrome.”

Amin Ariaee, a Ph.D. researcher at UniSA, explains that InuMCT offers a natural solution for obesity and related metabolic conditions:

Obesity is a global epidemic with many complex health issues beyond just weight gain… It’s a state of systemic inflammation driven by complex biochemical processes, rather than just excess calories. Unfortunately, current treatments often overlook the role of the gut microbiome, focusing instead on symptoms like weight and high blood sugar. Additionally, anti-obesity drugs can harm the gut microbiome, leading to unpleasant side effects like nausea, stomach pain, and diarrhea, and potentially making long-term inflammation and weight gain worse.”

Our research is different. The InuMCT microcapsules are made from natural, food-grade ingredients that support a healthy gut microbiome, reduce inflammation, and effectively address excess weight. The results have been very promising, both in terms of weight reduction and overall metabolic health.

Your responses and feedback are welcome!

Source: “Are weight loss drugs like Ozempic, Wegovy safe for kids?,” MedicalXPress, 12/9/24
Source: “Obesity drug worked in children ages 6 to 12, study says, raising hopes and concerns,” StatNews.com, 9/10/24
Source: “New food-grade natural solution created for tackling obesity,” News-Meidcal.net, 12/2/24
Image by Mika Baumeister on Unsplash

The Inevitable Growth of Companion Products

Pat Hartman December 10, 2024 No Comments

Way back in 2017, for DiabetesJournals.org, Deborah Hinnen noted that in a non-diabetes situation, expectations concerning weight loss should be realistic. This, she defined as looking to lose maybe 6 to 8 pounds altogether. Such a modest hope is quite different from the extravagant losses that have, since the advent of GLP-1 RA drugs, been reported in subsequent studies.

But the writer also noted that greater weight loss can be achieved, especially if the patient experiences the “feeling full” effect, and consequently eats less. And — here is the condition that, for the most part, is easier said than done — if the patient exercises conscientiously.

In those days, the potential of this genre of weight-loss drugs was not fully envisioned, and certainly not realized. But even back then, we can safely bet that the idea of “companion” products was a gleam in somebody’s eye.

A lot is going on today in the multifaceted world of seemingly magical weight-loss drugs that include semaglutides or GLP-1 RA drugs, such as Ozempic and Wegovy, as well as tirzepatides like Mounjaro and Zepbound. Will the questions ever end?

One very relevant query is, how many friends will the GLP-1 drugs eventually succeed in bringing to the party? We have discussed the companion candies that are meant to get some valid nourishment into the patient, in order to lessen the expected loss of lean muscle mass. This is only one of the ever-growing variety of supplementary foods created to make sure that enough of the right stuff gets into the diet of folks on the new drugs.

All is not well

By January of this year, it had been determined that a whopping 68% of patients were giving up on the GLP-1 meds before even 12 months had gone by. Even worse, by the 24-month (two-year) mark, six out of seven patients had flat-out discontinued the use of their GLP-1 medication.

But that is not all. Even though they had lost both fat and muscle mass, (and in some cases, muscle would constitute as much as 40% of the loss) the weight had a tendency to come back as pure fat, leaving them, for all practical purposes, worse off than before.

Even the CEO of digital health company Noomy warned that the drug alone is not enough. A regimen is needed too, a strong program incorporating a lot of changed behavior including a high-protein diet and some muscle-building exercise, or else…

[…] they risk losing a significant amount of muscle mass, strength, and bone density, which can result in lowered resting metabolic rate and worsening insulin resistance. All together this may lead to a complication called sarcopenic obesity, which is associated with worse prognoses from chronic disease and higher all-cause mortality.

In fact, Noom, the “highly-adaptable behavior change platform,” offers so many potentially helpful bells and whistles, to stay fit while shedding pounds could easily become a full-time job.

In February, Herbalife introduced its Nutrition Companion Classic, a product line that includes a shake mix, a protein drink mix, and a fiber drink available in a variety of flavors and designed to address the problems of malnutrition and decreased muscle density. These offerings are described as “low-glycemic, suitable for diabetics and vegetarians, presenting an opportunity for the development of diverse and accessible nutrition options for individuals on weight-loss regimens.”

Then in May, Nestlé, which had already quite definitively entered the companion product market, introduced a line called Vital Pursuit. It appears to consist of supplemental foods in the familiar guise of sandwich melts, pizzas, and bowls; described as high in protein, fiber, and nutrients, served up in budget-conscious portions “aligned to a weight-loss medication user’s appetite,” meaning, quite small.

In the following month, for Reuters, Jessica DiNapoli explained thoroughly how Nestlé avoids legal entanglements by not naming on the packaging the drugs to which its Vital Pursuit items are meant to be companions. Nestlé executive Tom Moe communicated that rather than mention the drug connection on wrappers, the company would do its marketing via social media. Other brands are more forthcoming, and will tell customers that their companion product might alleviate the nausea that many people experience from “the shot.”

(To be continued…)

Your responses and feedback are welcome!

Source: “Glucagon-Like Peptide 1 Receptor Agonists for Type 2 Diabetes,” DiabetesJournals.org, 2017
Source: “Noom GLP-1 Companion to Add “Muscle Defense” to Promote Safer GLP-1 Use,” BusinessWire.com, 01/19/24
Source: “Herbalife Debuts GLP-1 Nutrition Companion Classic,” TrendHunter.com, 02/15/24
Source: “Nestlé launches frozen food brand aimed at weight-loss drug users,” Axios.com, 05/21/24
Source: “Food companies wade carefully into weight-loss waters,” Reuters.com, 06/20/24
Image by David Shankbone/Attribution 2.0 Generic

Many-Sided Problem, Potent Solution

Pat Hartman December 5, 2024 No Comments

Today it is fashionable to assume that Artificial Intelligence will swoop in like a flying superhero and solve all the world’s puzzles. That hypothesis is far from proven. Another common belief is that the presumptive saviors, the new weight loss drugs, can and will be the answer for everybody with every type of counterproductive eating pattern.

Not so fast, starry-eyed optimists! Some cautious professionals are still, and quite appropriately, hung up on other basic questions, like who should decide which individuals really and truly need the GLP-1 RA drugs? Are children part of that population? For the young, shouldn’t other approaches be tried first? Especially an approach that involves neither surgery nor medication, because neither of those has proven to be totally harmless over the long term.

How much of what we categorize as dangerous obesity might actually be not-so-bad? Critics maintain that to categorize someone as in need of weight loss is often a matter of opinion. In this whole area of human experience, the wide variety of experiences is a minefield of possible error. Even adults who have logged plenty of miles and years are rarely able to control their eating habits, so how can we expect better from children? Even grownups need to be wary of solutions that seem too good to be true.

A cautious approach

An over-eater may coast along for many a year without feeling a serious need to address their issue, but could this be true for a professional actor vying for international prizes? A recent interview with Kathy Bates revealed interesting details of her experience, although not saying much about her weight status as a child. In fact, to search for evidence that obesity was a factor in her early years could occupy a solid chunk of time. It has, however, been documented that the mother-daughter relationship was far from ideal.

The photo on this page is from 2015 and the important thing is, even carrying a lot of extra pounds, Bates created a stellar acting career.

As time passed, some things happened, like major surgery, and type 2 diabetes. Eventually, and much to her credit, the artist did a self-appraisal and got serious. Over an approximately six-year period she lost 80 pounds, and then used Ozempic just long enough to shed another 20, landing at 145, which was 100 pounds less than her heaviest weight.

One drawback of Ozempic is that anyone who uses it (or similar drugs) and then quits will regain the weight. But maybe this is not an ironclad rule. In the course of vanquishing those 80 pounds, Bates had changed both the “what” and the “how” of her eating habits thoroughly enough to overcome that probability. It all paid off with a great new career opportunity, about which she says,

I wouldn’t have been able to withstand the long hours and the discipline of learning lines that a series requires. I can tuck in my shirts and close my jackets on set. I can stand all day and move in ways that were previously restricted by my weight.

I know it’s hackneyed, but for the first time in my life, I feel free of the sorrow and the burden […] of dealing with being a woman who can’t move and breathe.

After that segue to the “drawbacks” side of the equation, it is only fair to note that currently, what with one thing and another, many patients tend to have a miserable time with the GLP-1 RA drugs:

Perhaps these individuals could be better served by spending that money on psychological counseling, or any kind of therapy, rather than ingesting substances that may not offer permanent health, and indeed might cause actual harm.

Possible solution: May we suggest?

A recent article by Steve O’Keefe examines the concept of a universal addiction recovery program, giving BrainWeighve as an example, and asking and answering some questions:

Can it be fun? Can you turn recovery into a game? A challenging game? One with contests and conquests, rewards and disappointments, teams and fans? Can you make it a game where persons or teams are compensated with points, merchandise and prizes when they contribute solutions or assistance that other persons or teams find valuable?

It sounds like the universal addiction recovery program involves flipping the tables and using the mechanics of addiction to beat addiction. If you can make recovery self-directed, social and fun, the patient becomes addicted to recovery. And that’s a much healthier, happier affliction to deal with.

To dig into the question of whether BrainWeighve can be the answer for obese children and youth, here is a partial collection of our previous descriptions of various aspects of that program:

Your responses and feedback are welcome!

Source: “Kathy Bates at 76: What I Know Now,” AARP.org, 09/27/24
Source: “Toward a Universal Treatment for Addiction,” AddictionNews, 09/23/24
Image by Gage Skidmore/Attribution-ShareAlike 2.0 Generic

Study Finds That Weight Loss Drugs Reduce Alcohol Craving

Tatyana Meshcheryakova December 4, 2024 No Comments

A recent study found that many people using medications for obesity, such as Mounjaro or Wegovy, report a decreased enjoyment of alcohol.

The study, which surveyed WeightWatchers members on obesity medications, found that around half of those who previously drank alcohol reduced their consumption after starting the medication. As was reported by NPR, Tamara Hall, 45, a mother of three, is one such example. She began using Mounjaro in 2023 as part of a WeightWatchers program to manage her obesity and elevated blood sugar. Hall has since lost over 100 pounds, and although she was never a heavy drinker, she now consumes significantly less alcohol.

Hall, whose blood sugar levels have improved, was a moderate drinker who previously enjoyed wine or cocktails at social events. Hall found that her tolerance for alcohol dramatically decreased after starting the medication. One drink would make her feel full and dizzy, an effect she hadn’t experienced before. As a result, cutting back on alcohol was easy.

She said:

I feel amazing… It’s life-changing… I didn’t know it would have this effect — I just don’t crave alcohol anymore, and that’s a huge benefit.

The findings align with a new study published in JAMA Network Open. The study, “Alcohol Use and Antiobesity Medication Treatment,” explored the impact of anti-obesity medications (AOMs) on alcohol use among people in the WeightWatchers telehealth weight management program (January 2022–November 2023). As reported by Medical Xpress, participants had a mean age of 43 and were primarily female (86%). They were prescribed various AOMs, including GLP-1 receptor agonists (e.g., liraglutide, semaglutide), metformin, and bupropion/naltrexone (Contrave).

Of the 7,491 participants who used alcohol at baseline, 45.3% reduced their consumption, while 52.4% showed no change, and 2.3% increased their intake. Those with higher obesity levels and baseline alcohol use were more likely to reduce alcohol consumption. Notably, those taking bupropion and naltrexone had the greatest reduction in alcohol use, likely due to naltrexone’s ability to reduce cravings and rewarding effects, though this effect seemed tied to weight loss rather than the medication itself.

When adjusting for weight loss, the effect of bupropion and naltrexone disappeared, suggesting weight loss as a key factor in alcohol reduction. If AOMs reduce alcohol use through weight loss (e.g., via GLP-1 RAs), adjusting for weight loss might obscure the true contribution of the medications.

Interestingly, the reduction in alcohol consumption was observed across both newer obesity medications like Mounjaro and older drugs like metformin. “What surprised me was that alcohol consumption decreased among people using all types of anti-obesity medications,” says study author Lisa Matero, a health psychologist at Henry Ford Health. One possible explanation is that being part of a weight management program could encourage overall healthier behavior changes.

The study’s results add to a growing body of evidence suggesting that GLP-1 drugs, such as Mounjaro, have wide-ranging effects on behavior. Clinical trials of these medications have shown that participants report changes in their habits, such as drinking less or shopping less. Dr. Robert Kushner, a researcher at Northwestern University, explains that these drugs influence both appetite and the brain’s reward system, which may explain why many people also experience reduced cravings for alcohol.

While research on the topic continues, the findings highlight the potential of weight-loss medications not only for weight management but also for altering lifestyle habits like alcohol consumption. This comes at a time when there’s growing cultural awareness around the benefits of reducing alcohol intake for overall health and wellness.

Your responses and feedback are welcome!

Source: “Dizzy after one drink? Social drinkers on obesity drugs lose the taste for alcohol,” NPR, 12/2/24
Source: “WeightWatchers combined with weight loss medications may alter alcohol consumption, study finds,” Medical XPress, 12/1/24
Image by Heshan Perera on Unsplash

Weight-Loss Drugs and Human Subjects

Pat Hartman December 3, 2024 No Comments

In regard to GLP-1 RA drugs, a previous post asked a lot of questions about which questions most urgently need to be asked. That was only a few months ago, and maybe nothing major has happened, but the briefest web search assures us that plenty of people are working on it, and coming up with some startling possibilities.

The type of long-term research needed to settle all the questions must, obviously and unfortunately, be carried out over the long term — and by looking at the case files of many thousands of patients. Depending on variables, it must in some instances be extremely difficult for researchers to keep track of so many facts about so many people, over a span of years.

It may happen that some of the people under scrutiny develop conditions that take them outside the predetermined research parameters. They get pregnant, or move halfway around the world. Communication becomes difficult, or they just get tired of being totally conscious of and recording every detail of their existence.

Subjects may develop a reluctance to overshare, which morphs into an intense craving for privacy, especially if they are children entering adolescence, or teenagers turning into adults. Any individual might fall into a delusional wish to make the scientists happy; or feel the need, for whatever reason, to be less than honest with them.

You lookin’ at me?

When a subject is recruited, the research concerns literally every cell of their body. Tracking what they put into it and what comes out of it, is only the start. To live under a microscope can be taxing in ways that the subjects did not anticipate. Under those circumstances, some folks get antsy. They can fall into, or away from, religious or political convictions, or be caught up in an unhealthy emotional relationship, or be influenced by an individual who exerts control. They might be drafted into military service. In the worst case, some subjects die.

Over the long months that such observations should be expected to take, even the experience of mental or emotional growth could shake a person loose and make them unable to tolerate their participation for one more day. Just as some citizens will go to great lengths to avoid jury duty, a person who is really fed up with being part of an experiment will find a way out.

Ideally, a significant long-term study encompasses a very large number of participants. They might need to give up many informational tidbits, starting with simple ones like, “How much did your mother weigh when you were conceived?” and, “Now, 30 or 50 years later, how much do you weigh?” But gathering basic data is only the beginning.

Academia = intellectual rigor in lab coats

It all becomes fiendishly complicated, with linear miles of charts and suchlike. Another layer of complexity includes underlying philosophical assumptions and aspirations. According to what standards and rules must medical research be performed? What is seen as important, and what should be treated as even more important?

One thing we discover from research is how to do better research. Does the thinking on these matters advance, or has it solidified? When researchers write up their results, can they weasel without actually telling a lie? Why would anyone do that?

For a scientific researcher or anyone else, questions should never cease. Once a large number of 20-year studies of semaglutide, for instance, have been compiled, someone will come along and say, “Not good enough. This can’t be definitively judged until more evidence comes in — like for instance, a pile of 30-year studies.”

And quite rightly. Mistakes have been made. Science does not always progress in an immaculate, untarnished linear fashion. There have been errors and oversights, and that is unlikely to change.

Your responses and feedback are welcome!

Image by Beckie/Attribution 2.0 Generic

Of Mice and Men and Women

Pat Hartman November 29, 2024 No Comments

Anyone in any of the health professions will necessarily be aware of, and often intensely involved with, the results of scientific studies. Systemic investigations in the hard sciences include research development, testing, and evaluation that hopefully will contribute to the general pool of knowledge for the benefit of everyone.

How often do we think about what is really behind the numerous studies that must be completed in order for a drug or other treatment to eventually become acceptable to and accessible by the general public? Observing a caged rodent is a whole different proposition from keeping tabs on a human being. What behavior of the human subject will be observed? Will they be following their natural, normal course and recording it? Or dealing with something different being done to the natural course, like taking a different medication?

Any objections?

To track the trajectory of a planet is one thing. To convince a person to, for instance, meticulously record every particle of matter that goes into them and comes out of them is a whole different situation. Even with the most cooperative subject, in the most meticulously conducted experiment, there will be times when the person just wants out.

On other occasions, it might be that the professionals doing the research will decide to end a subject’s participation. In either case, there are plenty of guidelines and multiple strict rules, declared by different agencies, concerning any possible circumstance.

For the benefit of scientists connected with the Marshfield Clinic, MarshfieldResearch.org turned its attention to research itself in a document by Lori A. Scheller titled “Withdrawal of Subjects from Research.” In some instances, the participation of a human subject consists of interaction and/or intervention with the research team.

Or, it might be that their identifiable personal information is used, whether that information consists of data only, or specimens obtained from them. A whole set of rules defines what is considered individually identifying information. This is one of the circumstances that can lead to the involvement of lawyers.

A person might discontinue participation in a research study through voluntary withdrawal, and the federal government requires that human subjects retain the right to withdraw their informed consent at any time. In other cases, the Principal Investigator (PI) might end someone’s participation, for the good of the project. Of course, in any case where the PI withdraws a subject, it is strongly urged that the reasons be explained to that individual.

To prevent trouble, regulations demand that any prospective research participant (or parent of a participating minor) must be fully informed of their rights before they sign anything. The information about withdrawal, voluntary or otherwise, includes…

[…] statements that participation in the research is voluntary, that participation may be discontinued at any time without penalty or loss of benefits to which the subject is otherwise entitled, a description of any circumstances whereby an investigator may terminate a subject’s participation, consequences of withdrawal, and procedures for orderly withdrawal.

Then, there will be another whole set of rules about what happens to the data already generated by their previous involvement. For instance,

According to the guidance, a biological specimen collected but not analyzed prior to a subject’s withdrawal may not be analyzed following a subject’s complete withdrawal from a study…

The guidance states that an institution may choose to honor a subject’s request that his or her data be destroyed or excluded from further analysis at withdrawal, but only with agreement from the funding agency, and only if the research is not FDA-regulated.

Where the Food and Drug Administration is involved, however, there is a requirement for “all data collected on withdrawing subjects to remain as part of the study database or records after withdrawal.” This “ensures clinical study validity and prevents unreasonable risks to enrolled subjects, future subjects, and eventual users of marketed products”:

The FDA describes its concern that subjects who withdraw from research are more likely to have experienced adverse events or a failure of efficacy, and allowing exclusion of their data would increase the probability of introducing bias, and would negatively impact the scientific validity of the research.

What happens when a PI has to cope with a lot of the subjects quitting, or with the necessity to “withdraw” them through executive action? In that case, it might be time to fall back and regroup:

He or she should re-evaluate the protocol and determine whether changes are necessary to facilitate subject retention without weakening the scientific integrity of the research.

Your responses and feedback are welcome!

Source: “Withdrawal of Subjects from Research,” MarshieldResearch.org, 09/11/15
Image by Steve Jurvetson/Attribution 2.0 Generic

Experts Continue Evaluating Benefits and Risks of GLP-1 Agonists

Tatyana Meshcheryakova November 27, 2024 No Comments

As we know, over the past 30 years, rates of overweight and obesity in the U.S. have more than doubled, creating a growing public health crisis. Projections suggest that by 2050, 213 million adults and 43 million children will face overweight or obesity. Researchers have been emphasizing that urgent action is needed to address this issue.

A recent Medscape article looks into one promising intervention that involves glucagon-like peptide-1 receptor agonists (GLP-1 RAs), initially developed for diabetes and now approved for weight loss. These drugs have seen a dramatic rise in popularity, with prescriptions increasing by 132.6% from late 2022 to late 2024. Public awareness has also surged, with 32% of surveyed U.S. adults reporting familiarity with GLP-1 RAs in 2024, compared to just 19% in 2023.

GLP-1 RAs and their effectiveness

GLP-1 RAs, including tirzepatide (which targets additional receptors beyond GLP-1), have demonstrated effectiveness in weight loss. A 2022 analysis of 22 trials involving over 17,000 participants found that 50.2% achieved at least a 5% weight loss, while 17.5% experienced a ≥10% weight reduction compared to placebo. A subsequent 2023 review of 41 trials confirmed significant reductions in weight, BMI, and waist measurements.

Dr. Andres Acosta from the Mayo Clinic highlighted the long-standing use of GLP-1 RAs and the growing enthusiasm for their application in treating obesity. However, experts like Dr. Daniel Drucker from Mount Sinai Hospital caution that while these medications are highly effective, not everyone benefits. Approximately 10% of users may experience minimal weight loss or intolerable side effects.

Dr. Drucker said,

[W]e know some people don’t lose much weight when taking these medicines and others don’t feel well and can’t take them… [It’s} essential for us to identify who will be the best responders, as we do with medications for other conditions, such as cancer and cardiovascular disease.

Understanding obesity phenotypes

Dr. Acosta’s research has identified four obesity phenotypes that can guide treatment approaches:

Hungry Gut (HG). Patients experience rapid gastric emptying and feel hungry shortly after meals.
Hungry Brain. Individuals have impaired satiety and tend to overeat during meals.
Emotional Hunger. Emotional or hedonic eating behaviors dominate.
Slow Burn. Patients have a sluggish metabolism and burn fewer calories.

In a study of 312 patients, those receiving phenotype-specific treatments achieved significantly greater weight loss (15.9% vs. 9.0%) after one year. Acosta’s lab has developed a genetic test to predict the best responders to GLP-1 RAs, showing promise in identifying individuals who might benefit most. It’s licensed by Dr. Acosta’s lab and available through Phenomix Sciences.

His group has also studied which lifestyle interventions are most effective for each phenotype. Dr. Acosta said,

When a unique lifestyle intervention targeting each phenotype was applied, patients lost more weight and had greater metabolic improvement.

Concerns about side effects

Despite their benefits, GLP-1 RAs carry risks. Common side effects include nausea, diarrhea, and constipation, while more serious issues like pancreatitis and gallbladder diseases have been reported. Additionally, cases of compounded GLP-1 RAs from pharmacies have been linked to fatalities. These risks emphasize the need for cautious use, especially as discontinuation rates are high due to cost (over $12,000 annually) and side effects.

Optimizing treatment

Experts like Dr. Marc-Andre Cornier stress that GLP-1 RAs should be part of a broader strategy that includes lifestyle changes, such as a high-protein diet and resistance exercise to prevent muscle loss. Furthermore, precision medicine approaches tailored to individual phenotypes may enhance treatment success and minimize trial-and-error prescribing. Recently published recommendations can help healthcare experts guide patients taking GLP-1 RAs to optimize nutrition.

Public attitudes and sustainability

Despite rising interest, a recent survey found that most Americans prefer alternative methods, such as plant-based diets, over weight-loss injections. Moreover, many discontinue GLP-1 RAs within a year, raising concerns about long-term effectiveness and potential weight cycling.

Dr. Acosta highlighted the importance of identifying ideal candidates for these medications to maximize benefits while addressing cost and insurance coverage challenges. Tailored approaches are key to ensuring sustainable, effective obesity treatment.

Your responses and feedback are welcome!

Source: “As GLP-1 Use Surges, Clinicians Weigh Benefits and Risks,” Medscape, 11/22/24
Source: “Metabolic Bariatric Surgery in the Era of GLP-1 Receptor Agonists for Obesity Management,” JAMA Network, 10/25/24
Source: “Reasons for discontinuation of GLP1 receptor agonists…,” Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 9/29/17
Image by Towfiqu barbhuiya on Unsplash

Weight-Loss Drugs on the Horizon

Pat Hartman November 26, 2024 No Comments

There are medications that a child needs in order to preserve life, improve an aspect of health, or prevent a damaging condition from occurring. With some pharmaceutical products, like for instance GLP-1 weight-loss drugs, the case is not so clear-cut, and the use of such products on children can initiate a vigorous discussion among adults.

At any rate, no one wants to see minors sticking hypodermic needles into themselves. Even adults who need to treat their type 2 diabetes would prefer not to carry out the self-injection process day after day, but they don’t have a choice.

A healthcare marketing research and business consulting firm called DelveInsight is one of several similar companies that issue annual reports on the state of the pharmaceutical arts. The typical report covers the “present clinical development scenario and growth prospects” in the specialized market of weight loss and weight management. It describes “pipeline products from the pre-clinical developmental phase to the marketed phase.” According to DelveInsight,

In the report, a detailed description of the drug is proffered including mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Weight Loss/Weight Management (Obesity) collaborations, licensing, mergers and acquisition, funding, designations, and other product-related details.

Such a report includes all the companies in the field, along with descriptions of their various products in early-, mid-, and late-stage development. It includes information on the drug’s target receptor within the human organism, along with the route of administration, mechanism of action, molecular type, and whether it is suitable for monotherapy or combination therapy. The list of “key questions” covered by the report comprises 14 areas of inquiry. This year’s report covers more than 80 companies and 100 pipeline drugs. So there is a lot going on.

Weird and unanticipated

The human body has a vested interest in keeping unknown and potentially dangerous chemicals out of itself. Where medicine is concerned, in many cases the body can adapt, even though that might take time and entail discomfort. Science persists in trying to find ways to make ingestion work because needles are expensive, a lot of trouble to use properly and dispose of, and just generally icky.

Now let’s segue to tomorrow, and a fascinating article by Anil Oza about an amazing innovation the future might bring to the realm of drugs that require needles because the destructive nature of stomach acid precludes oral delivery. Very recently, STATNews.com reported on a device that is under development after drawing its inspiration from sea creatures. Hopefully, this item will introduce into the body drugs that formerly had to be injected either quickly by syringe or slowly via intravenous drip.

Described as blueberry-sized, it is meant to be swallowed. Also,

It then uses jets, modeled after the organs cephalopods use to propel themselves through the water and to release ink, to eject drugs into the tissue lining the digestive tract. The researchers report […] a series of experiments that serve as a proof of concept, showing that the device was more efficient at delivering drugs than other methods of delivering drugs orally.

The innovation has been tested on a pig, with GLP-1 drugs, and the outlook is promising although of course a long and complicated program of testing and more testing lies ahead. But the implications are exciting, especially if the results will make useful drugs available to children without the necessity for needles.

Your responses and feedback are welcome!

Source: “Obesity Pipeline Insight, 2024,” DelveInsight.com, undated
Source: “A new device for delivering drugs without needles draws inspiration from the elegant squid,” STATNews.com, 11/20/24
Image by Dawn Pedersen/Attribution 2.0 Generic

GLP-1 Drugs — Are Alternatives Feasible? (Continued)

Pat Hartman November 21, 2024 No Comments

This post is a continuation of a recent post.

A probiotic supplement may also contain golden turmeric extract (anti-inflammatory), black pepper extract (for bioavailability), sunflower lecithin, and other natural ingredients which are said to provide additional benefits. A fiber, glucomannan, helps a person to feel full, and various ingredients promote thermogenesis, or actual heat inside the body, which literally burns calories (or possibly not.)

A typical brand of natural stuff combines several ingredients and does come with the possibility of side effects which however are said to be rare. They are bloating, headache, and gut imbalance (dysbiosis), a particularly disconcerting outcome because one never knows whether to expect constipation or diarrhea, and they are pretty much the opposite phenomena.

But even if that internal chaos occurs, it is said to improve within weeks. One is tempted to ask, how many weeks? Four weeks? That would be a month, or one-12th of a year, at least. Many people prefer to remain overweight and enjoy life, instead.

A USNews.com article names seven high-satiety foods (high in fiber, healthy fats, and protein) and assures that a diet rich in them will aid in reaching weight loss goals. They are oats, barley, legumes, eggs, Greek yogurt, avocado, and fish. It goes on to say,

Foods high in protein, fiber and healthy fats can trigger the release of GLP-1 hormones and other satiety-enhancing effects… Eating more of these foods is less expensive than weight loss medications and have none of the unwanted side effects.

Even better, a piece by Joe Cannon, who for three decades has advised people about how to stoke up their own innards to manufacture their own GLP-1, names a total of 31 such foods. There are major groups, like fermented foods (yogurt, kefir and kimchi) and high-fiber foods (beans, oats, and barley), as well as resistant starch, whey protein, phytonutrients, Spinach Thylakoid Extracts, certain nuts and seeds, extra virgin olive oil, and other esoteric ingredients.

Along with the substances already mentioned, he recommends Resveratrol, glutamine, Valine, glycine, arginine, tryptophan, and more. Cannon also also warns of what to stay away from, and adds,

While going the natural route may not produce as impressive weight loss as drugs like Ozempic (semaglutide), it’s also true that it will cost less, and the risk of side effects may be lower, too.

…[T]he fact that natural therapies work is valuable knowledge to those who cannot afford these medications and who are averse to taking drugs for weight loss purposes.

A WebMD.com article by Jessica Migala adds some important information, namely that GLP-1 production is aided by exercise because it also facilitates the production of insulin, giving the body’s cells energy — and although research is not definitive, this appears to also be true for patients with type 2 diabetes. “Exactly what’s going on needs further study,” the report says.

Migala warns that natural supplements cannot achieve the same results as the drugs will. Although berberine might do something, the trials that opinion is based on have all used different doses and durations, so the overall picture is not clear. Also, it can cause the same nausea, bloating, and constipation that GLP-1 drugs are known for. She writes,

[I]t’s clear what the prescription medications are supposed to do, and at specific doses. But supplements may rely on preliminary or incomplete data, so it’s less clear what effect they will have on you.

The author warns patients to keep their physicians aware of anything they are taking, because some herbs and other remedies might interfere with or accentuate the effects of some medications. If the supplement route is chosen, it is important to try just one at a time, in order to be able to get clear answers about exactly what is working, and where the cause of any side effects can be found.

Your responses and feedback are welcome!

Source: “Provitalize Side Effects: What are the Side Effects of Provitalize Probiotics?,” TheBBCoo.com, undated
Source: “7 Foods that Mimic the Effects of Ozempic and Other GLP-1 Drugs,” USNews.com, 07/17/24
Source: “31 Best Foods and Supplements That Raise GLP-1 Levels,” SupplementClarity.com, 05/11/24
Source: “Can You Boost GLP-1 Naturally?,” WebMD.com, 07/26/24
Image by Michał Parzuchowski on Unsplash

What Doctors Say About Prescribing GLP-1 Receptor Agonists to Kids

Tatyana Meshcheryakova November 20, 2024 No Comments

Yesterday, MedPage Today published another part of its series called “Ozempic: Weighing the Risks and Benefits.” In the piece, Enterprise & Investigative Writer Sophie Putka examines how often doctors prescribe new weight loss drugs to kids and interviews a few professionals about their thinking process, reservations, and concerns.

As enthusiasm for GLP-1 receptor agonists as a weight-loss solution has grown, their use in children has also increased. Currently, liraglutide and semaglutide are the only GLP-1 drugs approved by the FDA for treating obesity in children aged 12 and older.

Between October 2022 and September 2024, prescriptions for these two medications by pediatric and adolescent medicine specialists surged from 3,448 to 24,435 — a sevenfold increase in just two years, according to a MedPage Today analysis of Symphony Health data. During this time, total prescriptions for all GLP-1 drugs written by these specialists more than doubled, rising from 59,868 to 125,538. These figures include prescriptions for 11 GLP-1 brands, many of which are approved for type 2 diabetes, but exclude those written by primary care or family medicine physicians and compounding pharmacies.

Many specialists feel cautiously comfortable prescribing GLP-1 medications to children when other options have been exhausted, provided that families are engaged in lifestyle interventions. However, concerns remain about long-term effects, particularly on bone density, and some experts remain uneasy about the rapid adoption of these drugs in pediatric care.

The jury is still deliberating

According to a recent article in Scientific American, written by Lauren J. Young, an associate editor for health and medicine, experts express concerns about potential impacts on bone health, growth, puberty, and restrictive eating habits, emphasizing the need for long-term studies like this JAMA study. These medications, considered lifelong treatments, pose unique challenges for teenagers compared to adults. Here at Childhood Obesity News, we also covered all kinds of questions and concerns regarding the potential risks of pediatric, adolescent, and adult use of GLP-1 drugs.

Still,

Clinical trials in younger age groups have shown significant weight and BMI reductions compared to lifestyle changes like diet and exercise, leading to FDA approvals of liraglutide (Saxenda) in 2020 and semaglutide (Wegovy) in 2022 for children 12 and older. A recent study reported a nearly 600% increase in GLP-1 prescriptions for adolescents and young adults between 2020 and 2023, largely driven by Wegovy’s approval for weight management in late 2022.

Proceeding with care

Last year, the American Academy of Pediatrics (AAP) issued an updated Clinical Practice Guideline for recommending the use of pharmacotherapy for adolescents 12 and up, including GLP-1 agonists.

Sarah Hampl, M.D., of the University of Missouri-Kansas City School of Medicine and lead author of the AAP guidelines, emphasized the role of other interventions that accompany medication. She said:

It was recommended, not in isolation or not as a monotherapy, but as adjunct or addition to intensive health behavior and lifestyle treatment… [AAP] needed to comment on [pharmacotherapy], because it can be a very effective form of treatment — again, as an adjunct and these kids, especially with severe obesity, they have some really serious and real comorbidities right here and now, in their childhood.

On the other hand, Dr. Fatima Cody Stanford, a pediatric obesity specialist at the Massachusetts General Hospital in Boston, avoids prescribing GLP-1 drugs to children under 12.

She said:

I would still probably use my other drugs where we do have some data, like a topiramate or metformin, or if they have very severe obesity, I would wonder if they had something else,” such as proopiomelanocortin (POMC) deficiency or leptin receptor deficiency.

Dr. Stanford ensures her adolescent patients receive comprehensive care, including dietitian support and psychological counseling, while closely monitoring bone health given the lack of long-term data on GLP-1 use.

It looks like family medicine doctors tend to use weight-loss drugs as a last resort. Dr. Tochi Iroku-Malize, former board chair of the American Academy of Family Physicians, noted that while medications might be necessary for some children with severe obesity, their long-term effects on developing bodies remain unclear.

She said:

When we’re starting with children, they have a longer way to go than adults when it comes to using these medications… [W]e don’t yet know what the long-term effects of taking the weight-loss medications are, and whether the young patients would have to continue taking them indefinitely to maintain their weight.

Despite these challenges, experts agree on the importance of combining medication with healthy lifestyle habits, stressing that the long-term success of any treatment relies on addressing the broader environmental and behavioral factors contributing to childhood obesity.

Your responses and feedback are welcome!

Source: “How Often Do Doctors Use New Weight-Loss Drugs in Kids?,” MedPage Today, 11/18/24
Source: “Teenagers Are Taking New Weight-Loss Drugs, but the Science Is Far from Settled,” Scientific American, 10/25/24
Image by Ben Wicks on Unsplash

Are GLP-1 Receptor Agonists Safe for Children?

Adolescent use of GLP-1 medications surges

Are weight loss drugs safe for children under 12?

The need for alternative solutions

A new natural treatment emerges

The Inevitable Growth of Companion Products

All is not well

Many-Sided Problem, Potent Solution

A cautious approach

Possible solution: May we suggest?

Study Finds That Weight Loss Drugs Reduce Alcohol Craving

Weight-Loss Drugs and Human Subjects

You lookin’ at me?

Academia = intellectual rigor in lab coats

Of Mice and Men and Women

Any objections?

Experts Continue Evaluating Benefits and Risks of GLP-1 Agonists

GLP-1 RAs and their effectiveness

Understanding obesity phenotypes

Concerns about side effects

Optimizing treatment

Public attitudes and sustainability

Weight-Loss Drugs on the Horizon

Weird and unanticipated

GLP-1 Drugs — Are Alternatives Feasible? (Continued)

What Doctors Say About Prescribing GLP-1 Receptor Agonists to Kids

The jury is still deliberating

Proceeding with care

Profiles: Kids Struggling with Weight

The Book

About Dr. Robert A. Pretlow

Presentations

Food & Health Resources