Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

Not Applicable

Withdrawn

• Conditions: Gut Hormones; Endoscopic Sleeve Gastroplasty; Laparoscopic Sleeve Gastrectomy; Glucose Metabolism Disorders
• Interventions: Procedure: Endoscopic sleeve gastroplasty; Procedure: Laparoscopic sleeve gastrectomy

• Registration Number: NCT04452786
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-05
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-05
• Primary Completion: 2022-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age > 18 years
• Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital
• HbA1c < 48 mmol/mol before surgery, and no history of diabetes
• HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion
• BMI<45

Exclusion Criteria

• Hemoglobin < 6.5 mmol/l at inclusion
• Pregnancy or breast feeding
• Medication affecting the planned examinations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Endoscopic sleeve gastroplasity operated patients	Endoscopic sleeve gastroplasty	Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
Laparoscopic sleeve gastrectomy operated patients	Laparoscopic sleeve gastrectomy	Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery

Primary Outcome Measures

Name	Time	Method
Changes in ghrelin (pg/ml)	240 minutes	Changes in ghrelin after a solid meal test compared before and after surgery

Secondary Outcome Measures

Name	Time	Method
Changes in gut hormone response before and after sugery (pmol/L)	240 minutes

Trial Locations

Locations (1)

Department of Endocrinology, Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark