Glucose-homeostasis After Endoscopic Sleeve Gastroplasty

NCT04063098 | Completed

• 1 other identifier: ESG_01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic sleeve gastroplasty (ESG) is a transoral endoscopic procedure that creates a tubular sleeve along the lesser curvature with a gastric volume of approximately 30%. Summarizing the available literature published since its introduction in 2013, ESG was capable to achieve \> 10% of sustained total body weight loss in a majority of mildly to moderately obese patients with the caveat of only minor adverse events. Besides weight loss, little is known about the metabolic effects of ESG. The present study seeks to measure markers of glucose homeostasis during oral glucose tolerance tests before and subsequently after application of ESG in 12 patients.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• Area under the curve for plasma glucose in oral glucose tolerance test

  Plasma glucose will be measured in oral glucose tolerance test following dapagliflozin and will be compared with concentrations measured following placebo. Active and inactivated glucagon like peptide I will be measured.

  From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes

Secondary Outcomes (6)

• Area under the curve for glucagon-like peptide I in oral glucose tolerance test

  From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes

• Area under the curve for gastric inhibitory peptide in oral glucose tolerance test

  From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes

• Area under the curve for glucagon in oral glucose tolerance test

  From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes

• Area under the curve for somatostatin in oral glucose tolerance test

  From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes

• Area under the curve for non-acyl ghrelin in oral glucose tolerance test

  From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes

Study Arms (1)

All participants

OTHER

Participants scheduled for endoscopic sleeve gastroplasty

Other: Oral glucose tolerance test

Interventions

Oral glucose tolerance test OTHER

Oral glucose tolerance test (OGTT) after a 72-hours standardized diet. OGTT will be performed 1 month prior to as well as 1, 3, 6, and 12 months after endoscopic sleeve gastroplasty

All participants

Eligibility Criteria

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

You may qualify if:

• Planned ESG
• Written informed consent
• Male or female sex
• Age 18-65 years
• BMI ≥ 40 kg/m2 OR
• BMI ≥ 35 kg/m2 and obesity-related comorbidities except type 2 diabetes

You may not qualify if:

• Type 1 or Type 2 Diabetes
• Type 2 Diabetes according to pathological OGTT at visit 2
• Mandatory use of medical drugs that influence glucose metabolism
• Participant had bariatric procedures other than ESG
• Abdominal surgery influencing glucose metabolism
• Moderate to severe chronic kidney, liver, or pancreatic disease
• Pregnancy or breastfeeding
• Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Markus Laimer, Prof. MD

  Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, University Clinics Bern, Inselspital, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: January 30, 2020
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: July 30th 2022
• Access Criteria: Contact with the Study Sponsor

Locations

CH (1)