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

March 6, 2013 updated by: Bernd Schultes, Cantonal Hospital of St. Gallen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria
  • Switzerland
      • St. Gallen, Switzerland, 9400
        • Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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.
Procedure: gastric bypass surgery
Active Comparator: non diabetic patients, non-bariatric abdominal surgery
oral glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery.
Procedure: 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.
Behavioral: very low caloric diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 days after gastric bypass

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
10 days after gastric bypass

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Collaborators

Medical University of Graz
European Foundation for the Study of Diabetes

Investigators

  • Principal Investigator: Bernd Schultes, Prof., Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switerland
  • Principal Investigator: Thomas Pieber, Prof., Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 5, 2011

First Posted (Estimate)

January 6, 2011

Study Record Updates

Last Update Posted (Estimate)

March 7, 2013

Last Update Submitted That Met QC Criteria

March 6, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKSG 09/061/2B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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