Endoscopy Sleeve Gastroplasty for Insulin Resistance and Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how endoscopic sleeve gastroplasty can help with obesity and insulin resistance. The goal is to examine how the body's immune system, particularly eosinophils, interacts with fat tissue in these conditions. Individuals with a BMI over 30, signs of insulin resistance, and a mostly sedentary lifestyle might be suitable candidates. Participants will undergo the procedure and be monitored for changes over several months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on obesity and insulin resistance.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications that affect glucose or lipid metabolism to participate in this trial.
What prior data suggests that endoscopy sleeve gastroplasty is safe for treating obesity?
Research has shown that endoscopic sleeve gastroplasty (ESG) is generally safe for people with obesity. Several studies have examined its safety over the years. One study found that ESG effectively treats obesity, with benefits lasting up to 10 years. Another study showed that ESG is well-tolerated and effective for at least 5 years.
These studies suggest that ESG can be a safe option for those seeking obesity treatment. Researchers reported no major safety issues, indicating that serious side effects are rare. This makes ESG a promising choice for people with obesity considering clinical trials.12345Why are researchers excited about this trial?
Endoscopic Sleeve Gastroplasty (ESG) is unique because it offers a minimally invasive approach to tackling obesity and insulin resistance. Unlike traditional bariatric surgeries like gastric bypass, ESG doesn't involve cutting or rerouting the stomach, which means a lower risk of complications and a shorter recovery time. Researchers are excited about ESG because it can be performed via endoscopy, using a flexible tube inserted through the mouth, which avoids the need for external incisions. This innovative method could help patients achieve significant weight loss and improve insulin sensitivity without the downsides of more invasive surgical options.
What evidence suggests that endoscopy sleeve gastroplasty might be an effective treatment for obesity and insulin resistance?
Research shows that endoscopic sleeve gastroplasty (ESG), the treatment under study in this trial, effectively addresses obesity and insulin resistance. Studies have found that ESG helps many people lose weight and maintain it for at least five years. In one study, 76.9% of participants saw their diabetes resolve after the procedure, while 15.4% experienced improvements. Additionally, most patients maintained significant weight loss two years after undergoing ESG. These findings suggest that ESG can be a promising option for improving conditions related to obesity.12346
Who Is on the Research Team?
Elena Anna O. De Filippis, MD, PhD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults with obesity (BMI>30 kg/m2) who are mostly sedentary, have insulin resistance (hemoglobin A1c > 5.7%), and plan to undergo endoscopic gastroplasty at Mayo Clinic Arizona. Participants should not have had significant weight changes in the past 6 months, be non-smokers, and not on medications affecting glucose or lipid metabolism.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects undergo endoscopic sleeve gastroplasty and are studied at baseline, 30, 60, and 90 days after the procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 90 days post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- Endoscopy Sleeve Gastroplasty
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor