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Clinical Trials/NCT01271062
NCT01271062
Completed
Not Applicable

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

Cantonal Hospital of St. Gallen2 sites in 2 countries55 target enrollmentOctober 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Cantonal Hospital of St. Gallen
Enrollment
55
Locations
2
Primary Endpoint
Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bernd Schultes

Head of Interdisciplinary Obesity Center

Cantonal Hospital of St. Gallen

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Pregnancy

Outcomes

Primary Outcomes

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 Outcomes

  • 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)
  • • Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis(10 days after gastric bypass)

Study Sites (2)

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