Endoscopic Sleeve Gastroplasty Versus GLP-1 Analogue for... | NCT05569304

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

NCT05569304

Sponsor

Sengkang General Hospital

Status

Unknown status

Last Update Posted

Oct 6, 2022Actual

Enrollment

66Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

Endoscopic sleeve gastroplasty

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2022Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Oct 4, 2022

First Submission Date that Met QC Criteria

Oct 4, 2022

First Posted Date

Oct 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2022

Last Update Posted Date

Oct 6, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chue Koy Min, Associate Consultant, Sengkang General HospitalPrincipal Investigator

Lead Sponsor

Sengkang General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic sleeve gastroplasty	Procedure	Endoscopic sleeve gastroplasty	Endoscopic Sleeve Gastroplasty Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total body weight loss	Percentage total body weight loss	1-year

Secondary Outcomes

Measure	Description	Time Frame
Short-term weight loss	Percentage total body weight loss	3-months
Short-term weight loss	Percentage total body weight loss	6-months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sengkang General Hospital		Singapore		544886	Singapore

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided