GLP-1 Drugs and Babies, Part 2

Any factor with the potential to affect a baby throughout its entire lifetime is not a thing to be taken lightly. A number of authorities have something to say about the subject of GLP-1 drugs in conjunction with pregnancy.

Many media articles mention Ozempic, a drug which, because of its early and widespread popularity, seems to stand in for and take the fall for the whole group of similar meds. But that one preparation does not represent the entire range of risk. Another brand’s packaging, for instance, warns of increased risk to the fetus, of cleft lip and cleft palate.

The Food and Drug Administration states that no one should take GLP-1 drugs if they are trying to become pregnant. For those who are planning on motherhood and are on a GLP-1, the FDA recommends stopping the medication at least two months before trying to conceive.

Jamie Winn, Pharm.D., told journalist Cathy Cassata,

While no studies have been conducted on pregnant people taking GLP-1 drugs, studies in animals such as rats, rabbits, and monkeys showed that these animals experienced high rates of miscarriages when they were given an injectable GLP-1 medication. The babies the animals gave birth to were smaller in size than usual and with more birth defects.

Just to complicate matters, pregestational diabetes has long been known to “increase the risk for potential pregnancy, including birth defects, miscarriage, fetal growth restriction, premature labor, and preeclampsia.” Some professionals believe that so far, weight-loss drugs offer no greater risk than insulin, which pregnant women with diabetes have needed to take.

Still, clinical endocrinologist Dr. Sethu Reddy has said that no GLP-1 receptor agonist is “indicated for improving fertility” and that “risk can not be ruled out.” On the other hand, GLP-1 receptor agonists seem to perform no worse than insulin, and patient acceptability and adherence are great advantages.

But this only applies to the small percentage of potential mothers who must receive extra protection because of their diabetes. Dr. Sonia Hernández-Díaz is quoted as saying,

[T]he safety of these agents in pregnancy is largely unknown, as pregnant women are typically excluded from clinical trials; hence, treatment guidelines do not recommend these agents in pregnancy.

Around the same time, a Swedish study provided reassurance about the prenatal exposure experienced by fetuses when the mothers are treated for obesity with semaglutide. Only a month later, it was announced that a study of 50,000 pregnancies in six countries, followed up for the first year after birth, provided “reassuring” answers regarding the GLP-1 drugs. Still, even though they apparently post no greater risk than insulin, one year of follow-up cannot tell the whole story.

A researcher who wants to know everything about the effects these drugs have on mothers and their babies cannot simply round up a group of suitable female subjects and keep them on the premises, while hourly monitoring every body function. Nor can they even pay women who have used or are using the substances to turn themselves and their fetuses into lab specimens.

(To be continued…)

Your responses and feedback are welcome!

Source: “Ozempic’s Effects on Pregnancy and Fertility: Experts Answer 4 Common Questions,” Healthline.com, 08/14/24
Source: “Are Weight Loss Drugs Like Ozempic Safe While Trying to Get Pregnant?,” Healthline.com, 04/25/23
Source: “Are GLP-1 receptor agonist drugs safe to use in pregnancy?,” MedicalNewsToday.com, 12/16/23
Source: “Prenatal exposure to GLP-1 receptor agonists and other second-line antidiabetics may not pose greater risk to infants than insulin,” Harvard.edu, 12/11/23
Source: “First Large Study of GLP-1 Receptor Agonists During Pregnancy,” JAMANetwork.com, 01/02/24
Image by Vladimir Pustovit/Attribution 2.0 Generic

As Obesity Booms, Doctors Seek Additional Treatment Options

A recent article on Medscape highlights the work and the opinions of Dr. Gitanjali Srivastava, a professor of medicine, pediatrics, and surgery, and the medical director of Obesity Medicine at Vanderbilt University, who had been practicing pediatric medicine for nearly a decade before completing an obesity medicine fellowship at Massachusetts General Hospital in 2013. Reflecting on that time, she recalls that there were no established guidelines or curricula for the specialty.

At that point, obesity was already a widespread issue, but there was still significant stigma both in the medical field and among the general public. After completing her fellowship, Dr. Srivastava spent months traveling and meeting with hospital executives across the country, explaining the importance and value of obesity medicine, covering details about its budget, business model, space needs, and revenue potential.

Specialized obesity treatment gains traction

Today, the field of obesity medicine is growing rapidly. More patients are seeking obesity treatment, and healthcare systems are actively recruiting specialists and building metabolic health centers. Since 2020, the number of doctors certified by the American Board of Obesity Medicine (ABOM) has nearly doubled, and fellowships have more than doubled as well. This year, over 2,100 doctors from various specialties will take the board exam, marking obesity medicine’s increasing integration with other medical fields.

The growing demand for obesity treatment has coincided with the U.S. Food and Drug Administration’s approval of GLP-1 injections, which have shown remarkable weight loss effects. Dr. Marcio Griebeler, head of the obesity medicine fellowship at Cleveland Clinic, explains that the recognition of obesity as a chronic disease, rather than a lifestyle issue, has been long overdue. Obesity treatment has shifted away from advice about diet and exercise to a more scientific understanding of the disease.

Dr. Kimberly Gudzune, chief medical officer for the ABOM Foundation, and others highlight that the brain functions differently in people with obesity, making it more challenging for them to lose weight through willpower alone. New treatments like GLP-1 have shown that obesity can be managed with medication, much like conditions such as high blood pressure or diabetes, but the disease often returns if treatment stops.

More obesity management and treatment training is needed

As more patients seek obesity care, doctors from various specialties are being asked about obesity treatment options, yet many feel unprepared due to a lack of education in this area. Medical training has historically neglected obesity and metabolic health, according to Dr. Nina Paddu, an obesity medicine specialist, who notes that her own training barely addressed these topics.

Dr. Srivastava explains that while the medical community has long sought to establish guidelines for obesity treatment, only recently has enough evidence emerged to create standards. Over the past five years, understanding of obesity’s underlying causes has advanced, with research highlighting the brain’s role and its connections to other diseases. This progress is transforming the way multiple specialties, including endocrinology and surgery, approach obesity.

In response to the growing need, more doctors are pursuing additional training in obesity management. The ABOM offers two certification pathways: completing 60 hours of continuing medical education (CME) credits or undertaking a 12-month fellowship. Dr. Srivastava points out that while the fellowship is more intensive, many physicians are choosing to immerse themselves in it to further their careers. Some return to their previous specialties, but many take on roles specifically focused on obesity medicine.

Despite the field’s growth, there are still not enough obesity specialists to meet the rising demand. With only a small percentage of U.S. physicians certified by the ABOM, many patients may not have access to comprehensive care. Dr. Gudzune emphasizes that while the field is expanding, it remains small relative to the number of patients in need.

Liraglutide is safe for kids as young as six, study finds

Speaking of weight loss medications, a new study shows that liraglutide, a drug already approved for treating obesity in adults and teens, is safe and effective for children as young as six when combined with diet and exercise. The results of the study were published in The New England Journal of Medicine. The drug was found to reduce body mass and slow weight gain in kids aged 6 to 11. Based on these results, the manufacturer, Novo Nordisk, has asked U.S. regulators to expand its use for this younger age group. If approved, it would be the first drug authorized for treating the most common form of obesity affecting over 20% of U.S. children in this age range.

The study involved 82 children, with those receiving liraglutide showing a 5.8% reduction in body mass index (BMI) after over a year of treatment, compared to a BMI increase of 1.6% in the placebo group. Nearly half of the children taking the drug saw significant health improvements. However, side effects, particularly gastrointestinal issues like nausea and vomiting, were common. While experts welcome the potential benefits of the drug, they urge caution in its widespread use due to the risks and lack of long-term data.

The study highlights liraglutide’s potential to treat the underlying causes of obesity in young children, potentially preventing serious health issues like diabetes and heart disease later in life. The trial will continue, with further results expected in 2027.

Your responses and feedback are welcome!

Source: “Doctors Seek Additional Obesity Training in Wake of Obesity Patient Boom,” Medscape.com, 10/1/24
Source: “Weight-loss drug Saxenda effective for kids as young as 6, study shows,” MSN.com, 9/29/24
Source: “Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial,” NEJM.org, 9/10/24
Image by Accuray on Unsplash

Childhood Obesity Awareness Month — Odds and Ends

Dengue fever is one of the reasons to avoid mosquitoes if at all possible. Millions of people catch it every year, and while four out of five don’t even show symptoms, others get it really bad — as in, total body pain, and bleeding from places that do not normally bleed. While many cases may be almost negligible, the disease can also usher in a miserable death. The same person might have a barely noticeable case one time, and the next time a fatal one.

To make matters worse, dengue has traveled to geographical areas where it did not use to exist, like the southern United States. And according to other recent news, both obesity and diabetes are risk factors that increase the likelihood of a person’s case of dengue being severe.

Researchers in Sri Lanka looked at 4,782 cases among young people aged 10 to 18. The Conclusions follow:

Obesity appears to be associated with an increased risk of hospitalization in dengue, which should be further investigated in longitudinal prospective studies. With the increase in obesity in many countries, it would be important to create awareness regarding obesity and risk of severe disease and hospitalization in dengue.

Another source pins down the hospitalization risk for obese children as being twice as high as for the others. The same report notes that “there has been limited focus on the impact of obesity on many infectious diseases.” Furthermore, the odds are worse for girls than for boys. (This caveat also applies to influenza, COVID-19, and “many other infections.”) Dengue has been identified as a Neglected Tropical Disease, so maybe having this connection pointed out will lead to more strenuous efforts toward prevention.

They just can’t seem to get it right

A study published in Nutrients reveals that “60% of all baby foods don’t meet standards established by the World Health Organization.” The research team tested 651 products sold by 10 different major retail chains and found that infant and toddler foods on supermarket shelves contain too much bad stuff and not enough good stuff:

In fact, researchers discovered that only about 30% of these products complied with the WHO’s protein recommendations and only 56% complied with sugar guidelines.

During the first year, a child does just fine with breast milk or iron-fortified formula. In the words of neonatal dietician Chelsea Britton, “Food before one is just for fun,” which is an excellent reason to ignore the commercial offerings and start acclimating a child to real food.

Recommended are “natural purees like yogurt, hummus, smashed beans, and smashed avocado.” Aim for protein, iron and calcium, and don’t add any salt or sugar. Let a child become accustomed to what real, genuine food is supposed to taste like, and don’t assume that your own jaded palate and overworked taste buds can be the judge of that.

In a separate but equally appalling offense, no brands meet the promotional standards set by the WHO, meaning that their advertising is misleading and the information they provide for the buyer is incorrect. It is forbidden to advertise a product as organic, non-GMO, BPA-free, or without artificial flavors or colors, if this claim is not factually true.

Forbidden, but apparently not enforceable. Another example would be calling something a fruit snack, whose main ingredient is flour. Lead researcher Daisy Coyle found that the average infant/toddler food label includes several prohibited claims. Only four products were found whose packaging featured no prohibited claims.

And don’t even look at the front label. Turn the jar around, take out your magnifier, and check the ingredients list and nutrition label, for the real story. Baby food from a grocery shelf should have a very short list of ingredients — the main vegetable, fruit or meat, and enough water to make it spoonable. The cereals, like oatmeal and rice, ought to contain added minerals and vitamins.

Your responses and feedback are welcome!

Source: “Dengue fever,” MayoClinic.org, undated
Source: “Is the rise in childhood obesity rates leading to an increase in hospitalizations due to dengue?,” AC.uk, 2024
Source: “Childhood obesity tied to double the risk of dengue hospitalization,” UMN.edu, 06/28/24
Source: “Most Baby & Toddler Foods Don’t Meet Nutrition Standards, Study Finds,” Parents.com, 08/28/24
Image by markus119/Attribution 2.0 Generic

Exactly How Multifactorial Is Childhood Obesity?

The full title of this study is “Unraveling Childhood Obesity: A Grounded Theory Approach” to Psychological, Social, Parental, and Biological Factors.” Its four authors are from three different universities and they look at seven major categories of interest: social factors; biological and genetic factors; psychological factors; family condition-related factors; feeding and health-related practices; parenting style factors; and consequences of obesity.

These are further broken down into a couple of dozen subcategories. In other words, there is very thorough coverage of everything that is known, or suspected, to affect the bodies of young humans. Why? Because…

Despite the extensive studies that have been conducted to explore the specific issue, the impact of several factors that influence, generate, worsen, and make chronic the phenomenon needs further exploration.

This work was done in order to come up with a “grounded theory” that includes them all. According to the study authors,

Grounded theory, as a qualitative research methodology, shows great potential for solving the complexities inherent in multifactorial issues. The aim […] is to construct a theoretical framework or a cohesive explanatory mechanism that explains the phenomena being studied. The application of grounded theory methodology includes analyzing and interpreting data that are mostly qualitative like observations, interviews, texts, and documents.

Needless to say, the numerous factors “interact in complex ways, highlighting the multifactorial nature of childhood obesity.” The authors begin by discussing BMI (body mass index) and other measurement tools, and note that “the absence of a universally agreed-upon definition” of childhood obesity makes every aspect of the search for knowledge more challenging. But it is more necessary than ever, because…

[…] obesity represents a significant component of the worldwide challenge of chronic illness and disability, carrying substantial social and psychological consequences that impact individuals of all ages and socioeconomic backgrounds.

In the realm of causation classification, which area holds the most sub-categories? Perhaps surprisingly to some interested parties, “social factors” includes an abundance of categories, five to be exact. One of them has to do with specific time periods, which in turn will surely be divided into even more sub-categories.

Three possibilities spring to mind. First, there is the historical era. When Americans plodded westward with covered wagons pulled by horses, very few cases of childhood obesity existed. Another place where time makes a difference is in the child’s lifespan. As one example, there appears to be a stage of infancy when trying to shovel solid food into a baby can cause lifelong damage to the digestive system.

Likewise, there is a specific time period during which a problem can be solved. Younger people are more likely to be able to lose weight through one means or another, while adults are more likely to stay fat. That is simply how things are and, as always, further research is needed on every front.

The “biological and genetic factors” category has four sub-categories, and so does “family condition-related factors.” Perhaps it is unfair, that what parents say, do, practice, preach, model, ignore, punish, reward, discuss, clam up about, encourage, discourage, and pay for (or don’t), makes so much difference. Family influence (and lack of it) is responsible for an awful lot, and there is no point in pretending.

One way or another, childhood obesity ends up being everybody’s problem. On the importance of starting early, agreement is universal. The need is felt to construct a theoretical framework that includes all the recognized factors and all the connections between them.

Your responses and feedback are welcome!

Source: “Unraveling Childhood Obesity: A Grounded Theory Approach,” ResearchGate.net, August 2024
Image by Roy Patrick Tan/Attribution-ShareAlike 2.0 Generic

New Findings on Liraglutide for Younger Children

September is National Childhood Obesity Month, and we don’t need to tell you that obesity is a growing health crisis in the United States, affecting people of all ages. For children, the situation is particularly alarming: nearly 20% of all children in the U.S. have obesity, a number that has tripled since the 1970s.

This troubling rise has serious implications, not only for their immediate health but also for their future well-being. Children with obesity often become adults with obesity, facing a higher risk of developing long-term health problems like diabetes, heart disease, and even cancer. Despite these risks, weight loss for children — especially younger ones — has proven to be a significant challenge.

Doctors have long recognized how difficult it is for individuals with obesity to lose weight, regardless of age. While medications like GLP-1 receptor agonists, including the well-known drug liraglutide, offer promising results for adults and teens, younger children have been left with fewer options.

Until recently, children under the age of 12 could only rely on lifestyle changes like diet, exercise, and counseling to manage their weight. However, groundbreaking research on liraglutide is showing that this may be about to change.

Study details

A new study published in the New England Journal of Medicine explains how GLP-1 drugs could play a critical role in treating obesity in younger children. Dr. Claudia Fox, a pediatrician from the University of Minnesota, presented the findings at the European Association for the Study of Diabetes conference. The study focused on children between the ages of 6 and 12 who had high BMIs. Over the course of a year, 82 children participated, with 56 receiving daily injections of liraglutide while the rest received a placebo. Both groups were also provided with counseling to promote healthy diet and exercise habits.

Study findings

The results were impressive. Children who received liraglutide saw their BMI drop by 5.8%, compared to a 1.6% increase in the placebo group. This difference — 7.4 percentage points — was even more significant than the results seen in studies with teenagers. According to Dr. Fox, these outcomes suggest that early intervention with medications like liraglutide may yield better results, possibly even preventing the progression of obesity as children grow older.

Safety and Side Effects

One of the key concerns about using weight-loss medications in younger children is safety. Fortunately, liraglutide proved to be safe for the participants in the study. While some children experienced side effects like nausea, diarrhea, and vomiting, these issues were generally mild and tended to subside as the trial progressed. Very few participants dropped out due to adverse reactions.

However, one major question remains unanswered: How long would children need to stay on these medications to maintain the benefits? Once the trial ended and children stopped taking liraglutide, their BMI started to increase again, though not as sharply as seen in older children. This suggests that while the drug may be effective, it might require ongoing use to sustain weight loss, similar to how other chronic conditions like diabetes or hypertension require long-term management.

Dr. Sarah Armstrong, a professor of pediatrics at Duke University and a co-author of the American Academy of Pediatrics guidelines, said that medication will probably be necessary for children with severe obesity; that is, a BMI of at least 35. She said:

It is pretty clear that without effective treatment, this does tend to get worse, not better, over time… If a child has severe obesity and maybe has developed some early life comorbidities, it’s probably the right thing to do.

Dr. Armstrong does have some concerns about the use of medications in young kids because of the long-term nature of treatment:

What happens to kids if you put them on medication that makes them less hungry while they’re still growing? Are they going to have delayed puberty? Are they going to have delayed growth? Will it somehow affect their bone density? Will it create disordered eating patterns that are going to cause other problems later in life?

A New Era of Treatment for Childhood Obesity?

The potential for GLP-1 drugs like liraglutide to revolutionize treatment for childhood obesity cannot be overstated. While lifestyle changes are crucial, they often aren’t enough on their own. Dr. Fox and other experts emphasize that obesity is a biological disease, not simply a matter of poor lifestyle choices. As such, more aggressive interventions — including medications and, in some cases, surgical procedures — may be necessary to provide meaningful results.

The implications of these findings could be enormous. Children with obesity face not only physical health challenges but also significant social stigma and emotional stress. Successfully treating obesity in childhood could lead to long-lasting health benefits, reducing the risk of complications like type 2 diabetes, heart disease, and even early puberty. This could also help ease the burden on healthcare systems in the long term.

However, more research is needed, and questions about long-term use, the cost, insurance coverage, potential effects on growth and puberty, and the best time to start treatment are still open.

Your responses and feedback are welcome!

Source: “Weight loss drug liraglutide shows promise for younger children with obesity, study finds,” CNN.com, 9/10/24
Source: “A Novo Nordisk weight loss drug lowers BMI in kids as young as 6,” NBC News, 9/10/24
Image by Lidya Nada on Unsplash