Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery

Overview

Bariatric operations such as the gastric bypass procedure provide a unique in vivo model of improvement of pathological beta cell function. The presented double-centre study aims to comprehensively investigate different aspects of beta cell function in patients with type 2 diabetes (T2DM) with a wide range of disease duration after gastric bypass. In parallel, our project will address the aspects of changes in enteroinsular and adipoinsular axes as well as the early and late changes of other defined parameters after gastric bypass surgery.

Full Title of Study: “Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery in Severely Obese Patients With Type 2 Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2012

Interventions

  • Procedure: gastric bypass surgery
  • Procedure: abdominal surgery
  • Behavioral: very low caloric diet

Arms, Groups and Cohorts

  • Active Comparator: T2DM patients before gastric bypass surgery
    • oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.
  • Active Comparator: Non-diabetic patient before gastric bypass surgery
    • oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.
  • Active Comparator: non diabetic patients, non-bariatric abdominal surgery
    • oral glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery.
  • Active Comparator: severely obese T2DM patients following a very low caloric diet
    • oral glucose tolerance test , botnia clamp, before as well after following a very low caloric diet. Very low caloric diet.

Clinical Trial Outcome Measures

Primary Measures

  • Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function
    • Time Frame: 10 days after gastric bypass

Secondary Measures

  • OGTT calculations and modelling describing beta cell response to oral glucose load; Insulin and C-peptide areas under the curve (AUCs) during OGTT quantifying the incretin effect.
    • Time Frame: 10 days after gastric bypass
  • • Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis
    • Time Frame: 10 days after gastric bypass

Participating in This Clinical Trial

Inclusion Criteria

  • > 18 years – indication forbariatric surgery or non-bariatric abdominal surgery Exclusion Criteria:

  • Pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cantonal Hospital of St. Gallen
  • Collaborator
    • European Foundation for the Study of Diabetes
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bernd Schultes, Head of Interdisciplinary Obesity Center – Cantonal Hospital of St. Gallen
  • Overall Official(s)
    • Bernd Schultes, Prof., Principal Investigator, Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switerland
    • Thomas Pieber, Prof., Principal Investigator, Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, Medical University of Graz, Austria

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