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

NCT05569304 | Unknown DMC

• 1 other identifier: CIRB Ref: 2022/2469
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Total body weight loss

  Percentage total body weight loss

  1-year

Secondary Outcomes (5)

• Short-term weight loss

  3-months

• Short-term weight loss

  6-months

• Short-term weight loss

  9-months

• Healthcare costs

  1-year

• Metabolic outcomes

  3-months, 6-months, 9-months, 12-months

Study Arms (2)

Endoscopic Sleeve Gastroplasty Arm

EXPERIMENTAL

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

Procedure: Endoscopic sleeve gastroplasty

Retrospective cohort

NO INTERVENTION

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

Interventions

Endoscopic sleeve gastroplasty PROCEDURE

Endoscopic sleeve gastroplasty

Endoscopic Sleeve Gastroplasty Arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sengkang General Hospital: lead

Study Sites (1)

Sengkang General Hospital

Singapore, 544886, Singapore

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: October 7, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)