NCT01271062

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

3.1 years

First QC Date

January 5, 2011

Last Update Submit

March 6, 2013

Conditions

Diabetes Mellitus, Type 2Bariatric Surgery Candidate

Keywords

Resolvment of Diabetes Mellitus, Type 2gastric bypass

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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 Arms (4)

T2DM patients before gastric bypass surgery

ACTIVE COMPARATOR

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

Procedure: gastric bypass surgery

Non-diabetic patient before gastric bypass surgery

ACTIVE COMPARATOR

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

Procedure: gastric bypass surgery

non diabetic patients, non-bariatric abdominal surgery

ACTIVE COMPARATOR

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

Procedure: abdominal surgery

severely obese T2DM patients following a very low caloric diet

ACTIVE COMPARATOR

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

Interventions

gastric bypass surgeryPROCEDURE
Non-diabetic patient before gastric bypass surgeryT2DM patients before gastric bypass surgery
abdominal surgeryPROCEDURE
non diabetic patients, non-bariatric abdominal surgery
very low caloric dietBEHAVIORAL
severely obese T2DM patients following a very low caloric diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Graz, 8036, Austria

Location

Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland

Sankt Gallen, 9400, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Interdisciplinary Obesity Center

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 6, 2011

Study Start

October 1, 2009

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

AU(1)CH(1)