Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Obesity Morbid
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 feasib...

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.

Tracking Information

NCT #
NCT04063098
Collaborators
Not Provided
Investigators
Principal Investigator: Markus Laimer, Prof. MD Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, University Clinics Bern, Inselspital, Bern, Switzerland