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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Bariatric Surgery Candidate
• Interventions: Procedure: gastric bypass surgery; Procedure: abdominal surgery; Behavioral: very low caloric diet

• Registration Number: NCT01271062
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-06
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-06
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• > 18 years
• indication forbariatric surgery or non-bariatric abdominal surgery

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	10 days after gastric bypass
• Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis	10 days after gastric bypass

Trial Locations

Locations (2)

Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland; 🇨🇭 St. Gallen, Switzerland

Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria; 🇦🇹 Graz, Austria