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

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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	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	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