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04/10/2025
Weโre thrilled to announce that our product has been officially recommended by the U.S. Food and Drug Administration (FDA)! ๐ As a medical product, we are fully committed to adhering to the FDAโs strict guidelines for monitoring and compliance, ensuring the highest standards of quality, safety, and effectiveness.
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04/10/2025
When the body needs energy, it breaks down fat into fatty acids and glycerol, which are then circulated and used by muscles and other tissues. If the body takes in more energy than it uses, the excess energy is converted to fat and stored in fat cells, leading to weight gain and fat accumulation. As women age, they may notice an increase in abdominal fat even if they are not gaining weight. This condition can be attributed to the weakened circulation and slowed metabolism that typically accompany the aging process.
04/10/2025
Hypertension is a major risk factor for cardiovascular and renal disease in the US and worldwide. Obesity contributes to much of the risk of primary hypertension through several mechanisms, including neurohormonal activation, inflammation, and renal dysfunction. As the prevalence of obesity continues to increase, so will hypertension and associated cardio-renal disease unless more effective obesity prevention and treatment strategies are developed. Lifestyle changes, including diet, reduction of sedentariness, and increased physical activity, are commonly recommended for people with obesity; however, these strategies have had limited long-term success in reducing fat, maintaining weight loss, and lowering blood pressure. Effective pharmacological and procedural strategies, including metabolic surgery, are additional options for treating obesity and preventing or mitigating obesity hypertension, target organ damage, and subsequent disease. Medications are available for short- and long-term obesity treatment, but prescriptions for these medications are limited. Metabolic surgery is effective for sustained weight loss, treatment of hypertension and metabolic disorders in many patients with severe obesity. Many questions remain unanswered about the pathogenesis of obesity-related diseases, the long-term efficacy of different treatment and prevention strategies, and the timing of these interventions to prevent obesity- and hypertension-mediated targets.
04/10/2025
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 โ also known as re-cellularization via electroporation therapy (ReCET) โ 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 โ 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 โ 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.
04/10/2025
This year, ๐ณ๐๐๐๐๐ยฎ focuses on โObesity as a Chronic Disease,โ 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 choiceโitโs 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 ๐ณ๐๐๐๐๐ยฎ 2025 offers you the chance to explore the latest cutting-edge research, treatments, evidence-based care, and strategies for improving outcomes. Whether youโre 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.
12/19/2024
The beauty of a woman is not in the fashion of her face, but in her true beauty, which is reflected in her soul. It was the care she kindly gave, the warmth she showed. A woman's beauty increases with age.
12/19/2024
True wealth is health, not gold and silver.
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