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NCT01271062 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01271062
Other study ID # EKSG 09/061/2B
Secondary ID
Status Completed
Phase N/A
First received January 5, 2011
Last updated March 6, 2013
Start date October 2009
Est. completion date December 2012

Study information
Verified date March 2013
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date December 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- > 18 years

- indication forbariatric surgery or non-bariatric abdominal surgery

Exclusion Criteria:

- Pregnancy

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Procedure:
• gastric bypass surgery

• abdominal surgery

Behavioral:
• very low caloric diet

Locations
Country Name City State
Austria Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria Graz
Switzerland Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland St. Gallen

Sponsors (3)
Lead Sponsor Collaborator
Cantonal Hospital of St. Gallen European Foundation for the Study of Diabetes, Medical University of Graz

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function 10 days after gastric bypass
Secondary 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. 10 days after gastric bypass
Secondary • Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis 10 days after gastric bypass
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