Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2022

Interventions

  • Procedure: Endoscopic sleeve gastroplasty
    • Four-hour solid mixed meal test
  • Procedure: Laparoscopic sleeve gastrectomy
    • Four-hour solid mixed meal test

Arms, Groups and Cohorts

  • Other: Endoscopic sleeve gastroplasity operated patients
    • Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
  • Other: Laparoscopic sleeve gastrectomy operated patients
    • Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Changes in gut hormone response before and after sugery (pmol/L)
    • Time Frame: 240 minutes

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hvidovre University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nora Elisabeth Hedb├Ąck, Principal Investigator – Hvidovre University Hospital

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