Endoscopic Sleeve Gastroplasty Versus GLP-1 Analogue for Class 1 and 2 Obesity Study

Not Applicable

Not yet recruiting

• Conditions: Obesity
• Interventions: Procedure: Endoscopic sleeve gastroplasty

• Registration Number: NCT05569304
• Lead Sponsor: Sengkang General Hospital

Brief Summary

The aim of this study is to compare the 1-year total body weight loss outcomes for Class 1 and Class 2 Obesity patients who have undergone endoscopic sleeve gastroplasty (ESG) in contrast to medical treatment with glucagon-like peptide-1 (GLP-1) analogues.

Detailed Description

Endoscopic sleeve gastroplasty (ESG) was developed with the aim of emulating the successful outcomes observed with sleeve gastrectomy, while obviating the need to permanently remove a large portion of the stomach. The recent MERIT trial reported that the estimated total body weight loss after ESG at 1-year was 13.6%, demonstrating superiority over lifestyle modifications alone.

Glucagon-like peptide-1 (GLP-1) analogues such as liraglutide or semaglutide are currently approved for the treatment of obesity and type 2 diabetes mellitus. Evidence supports the use of these medications in weight loss. The total body weight loss from GLP-1 analogues reportedly range between 7.8-13.8%.

As such, for patients with type 1 or 2 obesity who may not be candidates for bariatric surgery, the reported total body weight loss attainable by ESG and GLP-1 analogues appear comparable.

In this study, patients eligible and consented for ESG will be retrospectively matched against a group of patients who were previously placed on GLP-1 analogue treatment for class 1 and 2 obesity.

The primary outcome of the study will be total body weight loss at 1-year. We will also examine the short-term weight loss outcomes, metabolic outcomes, as well as healthcare costs between the 2 groups. Our hypothesis is that ESG will be non-inferior to GLP-1 analogues in weight loss and metabolic outcomes, with reduced healthcare costs, given the avoidance of repeated dosing.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Last Update Submitted: 2022-10-04
• Study First Posted: 2022-10-06
• Last Update Posted: 2022-10-06
• Study Start: 2022-10-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Patients with classes 1 (BMI 27.5 to 34.9) and 2 (BMI 35 to 39.9) obesity in accordance with the World Health Organisation recommendations but modified to the interventional thresholds recommended for Asian populations

Exclusion Criteria

• Patients with class 3 obesity and above (BMI > 40.0)
• Patients with contraindications to GLP-1 analogues
• Patients with contraindications to endoscopic sleeve gastroplasty
• Patients with previous bariatric or upper gastrointestinal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic Sleeve Gastroplasty Arm	Endoscopic sleeve gastroplasty	Prospective cohort of patients with classes 1 and 2 obesity that had consented to undergo endoscopic sleeve gastroplasty.

Primary Outcome Measures

Name	Time	Method
Total body weight loss	1-year	Percentage total body weight loss

Secondary Outcome Measures

Name	Time	Method
Short-term weight loss	9-months	Percentage total body weight loss
Metabolic outcomes	3-months, 6-months, 9-months, 12-months	HbA1c values
Healthcare costs	1-year	Patient costs associated with procedure, hospital stay, outpatient visits and pharmacological treatment

Trial Locations

Locations (1)

Sengkang General Hospital; 🇸🇬 Singapore, Singapore