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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

Tracking Information
First Submitted Date  ICMJE January 5, 2011
First Posted Date  ICMJE January 6, 2011
Last Update Posted Date March 7, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2011)
Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function
Change History Complete list of historical versions of study NCT01271062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2011)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Bariatric Surgery Candidate
Intervention  ICMJE
  • Procedure: gastric bypass surgery
  • Procedure: abdominal surgery
  • Behavioral: very low caloric diet
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2013)
55
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2011)
115
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01271062
Other Study ID Numbers  ICMJE EKSG 09/061/2B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bernd Schultes, Cantonal Hospital of St. Gallen
Study Sponsor  ICMJE Cantonal Hospital of St. Gallen
Collaborators  ICMJE
  • European Foundation for the Study of Diabetes
  • Medical University of Graz
Investigators  ICMJE
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
PRS Account Cantonal Hospital of St. Gallen
Verification Date March 2013

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