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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils (EOS), and adipose tissue (AT) in human health and in disease states such as 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 data supports the effectiveness of the treatment Endoscopy Sleeve Gastroplasty for Insulin Resistance and Obesity?

Research shows that Endoscopic Sleeve Gastroplasty (ESG) can lead to significant weight loss and improvement in conditions related to obesity, such as diabetes and high blood pressure. A study found that ESG resulted in a 16.2% weight loss in the short term and helped resolve diabetes in 55.4% of patients, indicating its effectiveness in managing obesity and related health issues. ^{1 2 3 4 5}

Is endoscopic sleeve gastroplasty safe for humans?

Endoscopic sleeve gastroplasty (ESG) is generally considered safe with minimal complications, but rare and serious complications can occur, sometimes requiring emergency surgery. Overall, it is widely adopted and has been shown to be safe in many cases. ^{6 7 8 9 10}

How is the treatment Endoscopy Sleeve Gastroplasty different from other treatments for insulin resistance and obesity?

Endoscopic Sleeve Gastroplasty (ESG) is unique because it is a minimally invasive procedure that reduces stomach size using an endoscopic suturing device, avoiding the need for traditional surgery. This makes it a safer option for high-risk patients or those who cannot undergo abdominal surgery, while still effectively promoting weight loss. ^{1 7 9 11 12}

Research Team

Elena Anna O. De Filippis, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty is feasible after failed modified primary obesity surgery endoluminal procedure. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Severe Insulin Resistance Improves Immediately After Sleeve Gastrectomy. [2018]

3. Spain pubmed.ncbi.nlm.nih.gov

Higher HOMA-IR index is associated with increased excess weight loss in patients with BMI≥35kg/m2 after vertical gastrectomy. [2021]

4. India pubmed.ncbi.nlm.nih.gov

Four-year outcomes for endoscopic sleeve gastroplasty from a single centre in India. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Medium-Term Weight Loss and Remission of Comorbidities Following Endoscopic Sleeve Gastroplasty: a Systematic Review and Meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty requiring emergent partial gastrectomy. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Endoscopic Sleeve Gastroplasty: A Practice Pattern Survey. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The Use of the Overstitch for Bariatric Weight Loss. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Endoscopic Sleeve Gastroplasty (ESG) for High-Risk Patients, High Body Mass Index (> 50 kg/m2) Patients, and Contraindication to Abdominal Surgery. [2021]

12. England pubmed.ncbi.nlm.nih.gov

A pilot study of implementation of endoscopic sleeve gastroplasty (ESG) in Norway. [2023]