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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01271062
First received: January 5, 2011
Last updated: March 6, 2013
Last verified: March 2013
History of Changes

January 5, 2011
March 6, 2013
October 2009
November 2012   (final data collection date for primary outcome measure)
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 ]
Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function
Complete list of historical versions of study NCT01271062 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
  • • Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis
  • • Plasma concentrations of incretins GLP-1 and GIP and their time profiles during OGTT and isoglycaemic iv. glucose infusion.
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Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery
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.
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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Diabetes Mellitus, Type 2
  • Bariatric Surgery Candidate
  • Procedure: gastric bypass surgery
  • Procedure: abdominal surgery
  • Behavioral: very low caloric diet
  • 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.
    Intervention: 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.
    Intervention: Procedure: gastric bypass surgery
  • Active Comparator: non diabetic patients, non-bariatric abdominal surgery
    oral glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery.
    Intervention: 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.
    Intervention: Behavioral: very low caloric diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
December 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Switzerland
 
NCT01271062
EKSG 09/061/2B
Yes
Not Provided
Not Provided
Bernd Schultes, Cantonal Hospital of St. Gallen
Cantonal Hospital of St. Gallen
  • European Foundation for the Study of Diabetes
  • Medical University of Graz
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
Cantonal Hospital of St. Gallen
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP