Endoscopy Sleeve Gastroplasty for Insulin Resistance and Obesity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Glucose, Lipid, Corticosteroids

Disqualifiers: Asthma, COPD, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

You have a body mass index (BMI) higher than 30, which means you are very overweight.

You may be a candidate for an endoscopic gastroplasty at Mayo Clinic Arizona

Your body weight has not changed by more than 5% in the past 6 months.

Exclusion Criteria

You have a history of chronic lung disease or allergic conditions.

You are currently taking corticosteroid medication.

You have had certain autoimmune diseases such as ulcerative colitis, Crohn's disease, or rheumatoid arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo endoscopic sleeve gastroplasty and are studied at baseline, 30, 60, and 90 days after the procedure

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 90 days post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopy Sleeve Gastroplasty

Trial Overview The study aims to understand how eosinophils interact with adipose tissue in conditions like obesity and insulin resistance by observing patients undergoing endoscopy sleeve gastroplasty—a procedure that reduces stomach size to aid weight loss.

How Is the Trial Designed?

Group I: Subjects with Obesity Experimental Treatment 1 Intervention

Subjects will be recruited to undergo endoscopic sleeve gastroplasty. The subjects will be studied at baseline, 30, 60, 90 days after procedure

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Endoscopic sleeve gastroplasty (ESG) was successfully performed on 10 patients in a Norwegian center, demonstrating its feasibility as a less invasive weight loss procedure compared to traditional bariatric surgery.

The procedure resulted in a mean total body weight loss of 12.2% at 26 weeks and 9.1% at 52 weeks, with acceptable safety, although one patient experienced a minor complication that was managed without further issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of implementation of endoscopic sleeve gastroplasty (ESG) in Norway. Tønnesen, CJ., Hjelmesæth, J., Aabakken, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7939770/

The Efficacy and Safety of Endoscopic Sleeve Gastroplasty as ... Five-year outcomes of endoscopic sleeve gastroplasty for the treatment of obesity. ... Improvement in insulin resistance and estimated hepatic steatosis ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667008923000204

Safety and efficacy of endoscopic sleeve gastroplasty and ... Another study reported that after 18 months of LSG, diabetes had been cured in 76.9% of individuals and improved in 15.4% [27]. The improvement in obesity- ...

3. cghjournal.org cghjournal.org/article/S1542-3565(20)31385-9/fulltext

Five-Year Outcomes of Endoscopic Sleeve Gastroplasty for ... Our results suggest that ESG is safe and effective for treatment of obesity, with durable long-term results for at least up to 5 years after ...

4. journals.lww.com journals.lww.com/ajg/fulltext/2024/10001/s2063_ten_year_outcomes_of_endoscopic_sleeve.2064.aspx

S2063 Ten-Year Outcomes of Endoscopic Sleeve ... Our results suggest that ESG is effective and safe for treatment of obesity, with durable long-term results for at least up to 10 years after the procedure.

5. gi.org gi.org/journals-publications/ebgi/kolb_chiang_feb2023/

Endoscopic Sleeve Gastroplasty Is Effective for Patients ... Among the 60 patients who had ESG and achieved >25% EWL, most (68%) maintained this at 104 weeks. Diabetes metrics (fasting glucose, hemoglobin ...

6. gut.bmj.com gut.bmj.com/content/74/Suppl_1/A259.1

P279 Safety and outcomes of endoscopic sleeve ... 13 patients have at least 6 months post procedure follow up. Average total body weight loss at 6, 12 and 24 months was 17.78%, 36% and 26.7% respectively.