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

NCT ID: NCT01271062

Last Updated: 2013-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2 Bariatric Surgery Candidate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

gastric bypass surgery

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

gastric bypass surgery

Intervention Type PROCEDURE

non diabetic patients, non-bariatric abdominal surgery

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

Group Type ACTIVE_COMPARATOR

abdominal surgery

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

very low caloric diet

Intervention Type BEHAVIORAL

Interventions

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gastric bypass surgery

Intervention Type PROCEDURE

abdominal surgery

Intervention Type PROCEDURE

very low caloric diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Foundation for the Study of Diabetes

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role lead

Responsible Party

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Bernd Schultes

Head of Interdisciplinary Obesity Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernd Schultes, Prof.

Role: PRINCIPAL_INVESTIGATOR

Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switerland

Thomas Pieber, Prof.

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, Medical University of Graz, Austria

Locations

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Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria

Graz, , Austria

Site Status

Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland

Sankt Gallen, , Switzerland

Site Status

Countries

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Austria Switzerland

Other Identifiers

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EKSG 09/061/2B

Identifier Type: -

Identifier Source: org_study_id

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