Glucose-homeostasis After Endoscopic Sleeve Gastroplasty

Effects of Endoscopic Sleeve Gastroplasty on Hormonal Markers of Glucose-homeostasis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Morbid
• Intervention / Treatment: Other: Oral glucose tolerance test

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Markus Laimer, Prof. MD; Phone Number: +41316323062 +41316323062; Email: Markus.Laimer@insel.ch
• Study Contact Backup: Name: Andreas Melmer, MD; Phone Number: +41316323062 +41316323062; Email: Andreas.Melmer@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All participants; Participants scheduled for endoscopic sleeve gastroplasty	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve for glucagon-like peptide I in oral glucose tolerance test	Glucagon-like peptide I 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
Area under the curve for gastric inhibitory peptide in oral glucose tolerance test	Gastric inhibitory peptide 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
Area under the curve for glucagon in oral glucose tolerance test	Glucagon will be measured 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	Somatostatin will be measured 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	Non-acyl Ghrelin will be measured 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 insulin in oral glucose tolerance test	Insulin will be measured in oral glucose tolerance test	From time-point 0 to 120 minutes during oral glucose tolerance test, measurement every 15 minutes

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Markus Laimer, Prof. MD, Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, University Clinics Bern, Inselspital, Bern, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: ESG_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: July 30th 2022
• IPD Sharing Access Criteria: Contact with the Study Sponsor
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No