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

Primary Purpose

Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Endoscopic sleeve gastroplasty
Sponsored by
Sengkang General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sengkang General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Endoscopic Sleeve Gastroplasty Arm

Retrospective cohort

Arm Description

Prospective cohort of patients with classes 1 and 2 obesity that had consented to undergo endoscopic sleeve gastroplasty.

Retrospective cohort of patients with classes 1 and 2 obesity who did not undergo endoscopic sleeve gastroplasty and had been put on GLP-1 analogues

Outcomes

Primary Outcome Measures

Total body weight loss
Percentage total body weight loss

Secondary Outcome Measures

Short-term weight loss
Percentage total body weight loss
Short-term weight loss
Percentage total body weight loss
Short-term weight loss
Percentage total body weight loss
Healthcare costs
Patient costs associated with procedure, hospital stay, outpatient visits and pharmacological treatment
Metabolic outcomes
HbA1c values

Full Information

First Posted
October 4, 2022
Last Updated
October 4, 2022
Sponsor
Sengkang General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05569304
Brief Title
Endoscopic Sleeve Gastroplasty Versus GLP-1 Analogue for Class 1 and 2 Obesity Study
Acronym
EGG
Official Title
Endoscopic Sleeve Gastroplasty Versus GLP-1 Analogue for Class 1 and 2 Obesity Study (EGG Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 7, 2022 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sengkang General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Sleeve Gastroplasty Arm
Arm Type
Experimental
Arm Description
Prospective cohort of patients with classes 1 and 2 obesity that had consented to undergo endoscopic sleeve gastroplasty.
Arm Title
Retrospective cohort
Arm Type
No Intervention
Arm Description
Retrospective cohort of patients with classes 1 and 2 obesity who did not undergo endoscopic sleeve gastroplasty and had been put on GLP-1 analogues
Intervention Type
Procedure
Intervention Name(s)
Endoscopic sleeve gastroplasty
Intervention Description
Endoscopic sleeve gastroplasty
Primary Outcome Measure Information:
Title
Total body weight loss
Description
Percentage total body weight loss
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Short-term weight loss
Description
Percentage total body weight loss
Time Frame
3-months
Title
Short-term weight loss
Description
Percentage total body weight loss
Time Frame
6-months
Title
Short-term weight loss
Description
Percentage total body weight loss
Time Frame
9-months
Title
Healthcare costs
Description
Patient costs associated with procedure, hospital stay, outpatient visits and pharmacological treatment
Time Frame
1-year
Title
Metabolic outcomes
Description
HbA1c values
Time Frame
3-months, 6-months, 9-months, 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sengkang General Hospital
City
Singapore
ZIP/Postal Code
544886
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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