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

Primary Purpose

Diabetes Mellitus, Type 2, Bariatric Surgery Candidate

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
gastric bypass surgery
abdominal surgery
very low caloric diet
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Resolvment of Diabetes Mellitus, Type 2, gastric bypass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

Sites / Locations

  • Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria
  • Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

T2DM patients before gastric bypass surgery

Non-diabetic patient before gastric bypass surgery

non diabetic patients, non-bariatric abdominal surgery

severely obese T2DM patients following a very low caloric diet

Arm Description

oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.

oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.

oral glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery.

oral glucose tolerance test , botnia clamp, before as well after following a very low caloric diet. Very low caloric diet.

Outcomes

Primary Outcome Measures

Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2011
Last Updated
March 6, 2013
Sponsor
Cantonal Hospital of St. Gallen
Collaborators
European Foundation for the Study of Diabetes, Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT01271062
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen
Collaborators
European Foundation for the Study of Diabetes, Medical University of Graz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Bariatric Surgery Candidate
Keywords
Resolvment of Diabetes Mellitus, Type 2, gastric bypass

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T2DM patients before gastric bypass surgery
Arm Type
Active Comparator
Arm Description
oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.
Arm Title
Non-diabetic patient before gastric bypass surgery
Arm Type
Active Comparator
Arm Description
oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.
Arm Title
non diabetic patients, non-bariatric abdominal surgery
Arm Type
Active Comparator
Arm Description
oral glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery.
Arm Title
severely obese T2DM patients following a very low caloric diet
Arm Type
Active Comparator
Arm Description
oral glucose tolerance test , botnia clamp, before as well after following a very low caloric diet. Very low caloric diet.
Intervention Type
Procedure
Intervention Name(s)
gastric bypass surgery
Intervention Type
Procedure
Intervention Name(s)
abdominal surgery
Intervention Type
Behavioral
Intervention Name(s)
very low caloric diet
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
• Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis
Time Frame
10 days after gastric bypass

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years indication forbariatric surgery or non-bariatric abdominal surgery Exclusion Criteria: Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Schultes, Prof.
Organizational Affiliation
Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Pieber, Prof.
Organizational Affiliation
Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, Medical University of Graz, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland
City
St. Gallen
ZIP/Postal Code
9400
Country
Switzerland

12. IPD Sharing Statement

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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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