Glucose-homeostasis After Endoscopic Sleeve Gastroplasty

NCT ID: NCT04063098

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2023-05-09

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.

Detailed Description

Endoscopic sleeve gastroplasty (ESG) is a transoral endoscopic procedure that utilizes full-thickness sutures extending from the prepyloric antrum to the gastroesophageal junction, creating a tubular sleeve along the lesser curvature with a gastric volume of approximately 30%. After the first feasibility study was available in 2013, multiple investigators published data on safety and efficacy of ESG. A recent meta analysis of novel endoscopic procedures revealed four observational studies on ESG. At 6, 12 and 24 months pooled excessive weight loss (EWL) was 52%, 53%, and 60% while pooled total body weight loss (TBWL) was 16%, 17%, and 20%, respectively.

Aside from its efficacy in terms of body weight loss, only a small number of investigations addressed metabolic changes in response to ESG so far. In a large retrospective analysis, which observed the outcomes of 1000 patients following ESG, 13 of 17 cases of type 2 diabetes mellitus (T2DM), all 28 cases of hypertension, and 18 of 32 cases of dyslipidemia were in complete remission by the third month of follow-up.

Summarizing the available literature, knowledge about effects of ESG on metabolism and glucose homeostasis is scarce. Available studies are subject to significant limitations in terms of sample size and or generalizability of results. The present study aims at a comprehensive determination of changes in hormonal regulators of glucose homeostasis after ESG in comparison to the preoperative state. Up to date, there are no structured and detailed analyses available that investigate glucose homeostasis following ESG. Proper glucose homeostasis yields a significant impact on a patients' quality of life and may - if deteriorated - be accompanied by a plethora of somatic and psychological constraints. The results of the present study seeks to investigate glucose homeostasis following ESG in detail. This may help to identify patients in need for further assistance regarding their post-interventional lifestyle in order to avoid e.g. hypoglycemia, and to further characterize patients' cohorts that will likely benefit from ESG.

Conditions

Obesity, Morbid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

All participants

Participants scheduled for endoscopic sleeve gastroplasty

Group Type: OTHER

Oral glucose tolerance test

Intervention Type: 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

Interventions

Oral glucose tolerance test

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Laimer, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

ESG_01

Identifier Type: -

Identifier Source: org_study_id