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:
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
ClinicalTrials.gov Identifier:
NCT01271062
First received: January 5, 2011
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 Bariatric Surgery Candidate |
Procedure: gastric bypass surgery Procedure: abdominal surgery Behavioral: very low caloric diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cantonal Hospital of St. Gallen:
Primary Outcome Measures:
- 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 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. [ 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 ]
| Enrollment: | 55 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
Procedure: gastric bypass surgery |
|
Active Comparator: non diabetic patients, non-bariatric abdominal surgery
oral glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery.
|
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.
|
Behavioral: very low caloric diet |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- > 18 years
- indication forbariatric surgery or non-bariatric abdominal surgery
Exclusion Criteria:
- Pregnancy
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01271062
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271062
Locations
| Austria | |
| Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria | |
| Graz, Austria, 8036 | |
| Switzerland | |
| Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland | |
| St. Gallen, Switzerland, 9400 | |
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
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 |
More Information
| Responsible Party: | Bernd Schultes, Head of Interdisciplinary Obesity Center, Cantonal Hospital of St. Gallen |
| ClinicalTrials.gov Identifier: | NCT01271062 History of Changes |
| Other Study ID Numbers: | EKSG 09/061/2B |
| Study First Received: | January 5, 2011 |
| Last Updated: | March 6, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by Cantonal Hospital of St. Gallen:
|
Resolvment of Diabetes Mellitus, Type 2 gastric bypass |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 27, 2016