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

• ClinicalTrials.gov Identifier: NCT01271062
• Recruitment Status: Completed
• First Posted: January 6, 2011
• Last Update Posted: March 7, 2013
• Sponsor: Cantonal Hospital of St. Gallen
• 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: January 5, 2011
• First Posted Date: January 6, 2011
• Last Update Posted Date: March 7, 2013
• Study Start Date: October 2009
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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 (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 (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: Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Diabetes Mellitus, Type 2
• Bariatric Surgery Candidate

Intervention

• Procedure: gastric bypass surgery
• Procedure: abdominal surgery
• Behavioral: very low caloric diet

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 6, 2013): 55
• Original Estimated Enrollment (submitted: January 5, 2011): 115
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Switzerland

Administrative Information

• NCT Number: NCT01271062
• Other Study ID Numbers: EKSG 09/061/2B
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bernd Schultes, Cantonal Hospital of St. Gallen
• Study Sponsor: Cantonal Hospital of St. Gallen

Collaborators

• 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

• PRS Account: Cantonal Hospital of St. Gallen
• Verification Date: March 2013