Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

Not Applicable

Withdrawn

• Conditions: Gut Hormones; Endoscopic Sleeve Gastroplasty; Laparoscopic Sleeve Gastrectomy; Glucose Metabolism Disorders

• 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• Status: WITHDRAWN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

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