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

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ClinicalTrials.gov Identifier: NCT01271062
Recruitment Status : Completed
First Posted : January 6, 2011
Last Update Posted : March 7, 2013
Sponsor:
Collaborators:
European Foundation for the Study of Diabetes
Medical University of Graz
Information provided by (Responsible Party):
Bernd Schultes, Cantonal Hospital of St. Gallen

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Bariatric Surgery Candidate Procedure: gastric bypass surgery Procedure: abdominal surgery Behavioral: very low caloric diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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 Start Date : October 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. • Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis [ Time Frame: 10 days after gastric bypass ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271062


Locations
Austria
Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria
Graz, Austria, 8036
Switzerland
Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland
St. Gallen, Switzerland, 9400
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
European Foundation for the Study of Diabetes
Medical University of Graz
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Bernd Schultes, Head of Interdisciplinary Obesity Center, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01271062     History of Changes
Other Study ID Numbers: EKSG 09/061/2B
First Posted: January 6, 2011    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Bernd Schultes, Cantonal Hospital of St. Gallen:
Resolvment of Diabetes Mellitus, Type 2
gastric bypass

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases