Dr. Lara Winters

02/11/2025

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02/11/2025

Hypertension is a major risk factor for cardiovascular and renal diseases in the United States and worldwide. Obesity accounts for much of the risk for primary hypertension through several mechanisms, including neurohormonal activation, inflammation, and kidney dysfunction. As the prevalence of obesity continues to increase, hypertension and associated cardiorenal diseases will also increase unless more effective strategies to prevent and treat obesity are developed. Lifestyle modification, including diet, reduced sedentariness, and increased physical activity, is usually recommended for patients with obesity; however, the long-term success of these strategies for reducing adiposity, maintaining weight loss, and reducing blood pressure has been limited. Effective pharmacotherapeutic and procedural strategies, including metabolic surgeries, are additional options to treat obesity and prevent or attenuate obesity hypertension, target organ damage, and subsequent disease. Medications can be useful for short- and long-term obesity treatment; however, prescription of these drugs is limited. Metabolic surgery is effective for producing sustained weight loss and for treating hypertension and metabolic disorders in many patients with severe obesity. Unanswered questions remain related to the mechanisms of obesity-related diseases, long-term efficacy of different treatment and prevention strategies, and timing of these interventions to prevent obesity and hypertension-mediated target organ damage. Further investigation, including randomized controlled trials, is essential to addressing these questions, and emphasis should be placed on the prevention of obesity to reduce the burden of hypertensive cardiovascular and kidney diseases and subsequent mortality.

02/11/2025

02/11/2025

The availability of endoluminal bariatric and metabolic therapies (EBMTs) approved by the Food and Drug Administration (FDA) for obesity has increased significantly. In this article, part 2 of a series, Dilhana S. Badurdeen, M.B.B.S., M.D., discusses small bowel EBMTs, including the duodenojejunal bypass sleeve, duodenal mucosal resurfacing or ablation, pharmacological duodenal exclusion therapy, duodenal mucosal electroporation therapy, and gastric mucosal ablation.

Dr. Badurdeen and Vivek Kumbhari, M.B., Ch.B., Ph.D., gastroenterologists at Mayo Clinic in Florida, are co-authors of a review article published in a 2023 issue of Current Opinion in Gastroenterology that summarizes the current state of EBMTs.

"The aims of small bowel endoluminal bariatric and metabolic therapies vary," explains Dr. Badurdeen. "Some of these therapies attempt to prevent the passage of ingested nutrients to the proximal small intestine, replicating the effects of gastric bypass surgery. Others are designed to target duodenal mucosal cells, with the goal of modifying the incretin pathway to enhance insulin sensitivity."

Duodenojejunal bypass sleeve
The duodenojejunal bypass sleeve is an endoscopically inserted implant that prevents nutrient digestion and absorption at the proximal small intestine. Using a self-expandable metal stent, the endoscopist anchors the device to the duodenal bulb and places a Teflon sleeve into the proximal small bowel.

"A number of studies have investigated the safety and efficacy of this treatment for patients with poorly controlled diabetes mellitus," explains Dr. Badurdeen. "Although this device has demonstrated the potential to address obesity and metabolic disorders by targeting the proximal small intestine, it has not yet obtained FDA approval. More information will be available after the completion of another multicenter study in the United States."

Duodenal mucosal resurfacing (DMR)
Also known as duodenal mucosal ablation, this is an endoscopic technique that involves mucosal injection, lifting and ablation with a device that targets the distal 10 cm of duodenal mucosa after the major papilla. Several models of this device are available, some of which are FDA approved for adults with inadequately controlled type 2 diabetes (T2DM) on long-acting insulin. Other models are undergoing clinical trials for patients with suboptimally controlled T2DM.

"DMR appears to improve glycemic control independent of weight loss," explains Dr. Badurdeen. "Participants in a multicenter study had decreases in HbA1c and fasting blood sugar levels, which were maintained at 12 months, and improvements in insulin resistance."

Pharmacological duodenal exclusion therapy
This approach involves the use of a proprietary pH-activated mucin complexing polymer that is designed to enhance the duodenum's natural mucous barrier. The polymer is not absorbed and provides a temporary barrier that replicates duodenal exclusion physiology.

"This approach is aiming for results similar to gastric bypass surgery," explains Dr. Badurdeen. "A phase 1 randomized double-blinded safety clinical trial demonstrated that the polymer was safe at doses up to 6 grams per day, with some mild to moderate adverse effects reported, mostly at higher doses," explains Dr. Badurdeen. "Although the researchers observed a significant reduction in postprandial glucose levels on day 1, that reduction was not sustained through day 5, with similar results observed for postprandial bile acid increases. Results from a phase 2 double-blinded, randomized clinical trial that are not yet published may provide additional insights."

Duodenal mucosal electroporation therapy
This approach — also known as re-cellularization via electroporation therapy (ReCET) — uses pulsed electric fields targeting the duodenal mucosa. The goal is to improve regulation of blood glucose and insulin levels by inducing controlled electroporation and apoptosis of duodenal cells, which then regenerate and restore their original function. Read more about the preliminary results from the REGENT-1-US trial and Mayo Clinic researchers' involvement in the development and testing of the ReCET procedure here.

Gastric mucosal ablation (GMA)
Also called gastric mucosal devitalization (GMD), this minimally invasive bariatric procedure is designed to emulate the weight-independent metabolic effects of laparoscopic sleeve gastrectomy (LSG). During GMA, the endoscopist selectively ablates the gastric mucosal cells, inducing weight loss by manipulating metabolic pathways.

In an article published in Obesity Surgery in 2022, Drs. Badurdeen and Kumbhari and colleagues determined the optimal ablation parameters and that the optimal percent surface area to ablate is 70%. Overall, they observed an improvement in glucose and lipid metabolism and favorable cardiovascular changes in the animals that were randomized to GMD.

Drs. Badurdeen and Kumbhari and others are now conducting clinical trials to assess the feasibility and safety of GMA. In the COMET EF — Step 1 study, the researchers assessed the histopathological outcome and safety of ablation in combination with submucosal saline injection. They successfully performed ablation on stomach tissue sites that were resected 3 to 5 days later during planned sleeve gastrectomy in six research participants with obesity.

The Comet EF — Step 2 is a prospective, single-arm pilot study conducted at two sites. This study is designed to determine if ablating up to 70% of the gastric mucosa in a two-step procedure is technically feasible, safe and tolerable as a therapeutic approach for patients with obesity. Research participants are adults with class 1 to class 3 obesity who receive two treatment sessions, eight weeks apart. The researchers will note the total body weight loss at six months after the last treatment session.

02/11/2025

This year, ObesityWeek® focuses on “Obesity as a Chronic Disease,” emphasizing the need for a comprehensive approach to this complex condition, including the prevention and treatment of its complications. Obesity is not just a lifestyle choice—it’s a serious, long-term disease with far-reaching health impacts. Treating Obesity First means recognizing obesity as the root cause of many related health issues and prioritizing its management in clinical care. Attending ObesityWeek® 2025 offers you the chance to explore the latest cutting-edge research, treatments, evidence-based care, and strategies for improving outcomes. Whether you’re a healthcare provider, researcher, or advocate, join us to be part of a global movement transforming how we treat obesity and support individuals living with this chronic disease through the message of Treating Obesity First.

02/11/2025

Lara Winters, PhD, professor of nutrition and exercise physiology and the Associate Director of the Clinical Research Center at the Institute for Clinical Translational Science, awarded the 2023 Edwin Bierman Award for contributions to diabetes research.

02/11/2025

Obesity is rising among individuals diagnosed with inflammatory bowel disease (IBD), a trend that has led researchers to question how it may impact the natural history of IBD.

To shed light on this topic, Mayo Clinic researchers conducted a population-based study in a cohort of individuals with newly diagnosed Crohn's disease (CD). The results of that study were published in the Journal of Clinical Gastroenterology in 2024.

"Recently published data suggest that obesity, particularly increased visceral adiposity, may negatively impact IBD-specific outcomes such that patients experience an increased risk of penetrating or fibrostenotic disease, a reduced response to biologic therapies, and a higher risk of postoperative Crohn's recurrence. But the full extent of these impacts is not well understood," explains Amanda M. Johnson, M.D., lead author on the study publication. Dr. Johnson is a gastroenterologist at Mayo Clinic in Rochester, Minnesota.

Dr. Johnson and co-authors sought to describe the prevalence of obesity in the study population and the impact obesity has on disease phenotype and outcomes, including corticosteroid use, hospitalization, intestinal resection, and development of fistulizing or penetrating disease.

Study methods
The researchers performed a chart review of Olmsted County, Minnesota, residents diagnosed with CD between 1970 and 2010 whose medical records included body mass index (BMI) data within six months of their diagnosis. They analyzed the proportion of individuals considered obese at the time of CD diagnosis and how that changed over time. Using Kaplan-Meier survival analysis, they assessed any CD-associated complications that occurred within that cohort, including hospitalizations, corticosteroid use and intestinal resection.

Results
Among 334 individuals diagnosed with CD, 156 (46.7%) were classified as overweight (27.8%) or obese (18.9%) at the time of diagnosis.
Participants classified as overweight or obese tended to be older at the time of their CD diagnosis (42.3 and 44.3 years, respectively) as compared with those who were considered underweight or normal weight (31.6 and 35.8 years, respectively).
Over the course of the 40-year study period, the proportion of patients classified as obese at the time of CD diagnosis increased two- to threefold. During the 1970s, approximately 9% of individuals diagnosed with CD had comorbid obesity, though this proportion rose to more than 20% of individuals diagnosed between 2000 and 2010.
Obesity at the time of CD diagnosis did not appear to significantly impact future risk of corticosteroid use, hospitalization, intestinal resection, or the development of penetrating and stricturing complications.
"Our findings demonstrate that obesity is increasingly common in patients with Crohn's disease, with rates having more than doubled in recent decades," explains Dr. Johnson. "It is important to note that the presence of obesity was captured at the time of Crohn's disease diagnosis, and thus should not have been impacted by weight gain from factors like corticosteroid use or smoking cessation."

Dr. Johnson and co-authors acknowledge that this study had a few limitations. Patients diagnosed with CD in 1970s did not have access to the same advanced therapies available today. This creates a more heterogenous population, leading to the possibility that associations between obesity and CD-related outcomes may have been overlooked or skewed. Additionally, although BMI is widely used as a measure of obesity, the researchers note that it is not the most accurate surrogate measure. Dr. Johnson notes that prospective studies including measures such as visceral adipose tissue assessment may help researchers paint a clearer picture of how obesity affects CD outcomes.

Overall, Dr. Johnson notes that this study provides some useful takeaways for clinicians.

"It is important for us as care providers to be mindful that many patients with IBD are struggling with comorbid obesity," says Dr. Johnson. "This fact may have negative implications for our patients' general health outcomes as well as potentially their IBD outcomes. Additional research is needed to better understand how to provide the most effective and safest weight-loss therapies to patients with IBD, as these individuals are typically excluded from clinical trials of these interventions."

"It is important for us as care providers to be mindful that many patients with IBD are struggling with comorbid obesity. This fact may have negative implications for our patients' general health outcomes as well as potentially their IBD outcomes."

— Amanda M. Johnson, M.D.
Additional related research
The 2024 study publication is a part of a larger research effort that Dr. Johnson and co-investigators are conducting. "The ultimate goal of these studies is to augment our ability to provide more evidence-based approaches and personalized care to patients struggling with both obesity and IBD," says Dr. Johnson.

In a 2023 publication in The American Journal of Gastroenterology, Dr. Johnson and colleagues shared the results from a single-center experience with the use of anti-obesity medications in patients with IBD. They also affirmed the safety and efficacy of endoscopic bariatric therapies in a cohort of seven patients with IBD and published those results in Obesity Surgery in 2023.

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