Characterization of Beta Cell Failure

This study is not yet open for participant recruitment.

Verified by University Hospital Tuebingen, March 2009

First Received: March 23, 2009 No Changes Posted

Sponsors and Collaborators:	University Hospital Tuebingen MSD Sharp & Dohme GmbH
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00869102

Purpose

The purpose of this study is to characterise beta cell function in subjects who despite taking part in a diabetes prevention program (life style intervention with diet and exercise) exhibit impaired glucose tolerance and beta cell dysfunction.

Condition	Intervention
Diabetes Metabolic Syndrome	Drug: GLP-1

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Insulin secretion [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
GLP-1: Experimental	Drug: GLP-1 intravenous, 124,5 pmol/kg body weight

Detailed Description:

We have identified a subgroup of individuals with a good compliance to lifestyle intervention to prevent diabetes who lose body weight and increase insulin sensitivity, however they remain impaired glucose tolerant. These individuals show a deterioration in insulin secretory function.

We will identify a highly selected group of subjects with prediabetes that displays a large defect in insulin secretory function.We will study 50 individuals who display these characteristics and 50 subjects who do not display these characteristics. Their insulin secretion capacity in response to different secretagogues (glucose, GLP-1, arginine) will be studied. We expect to detect new pathophysiologic aspects that lead to beta cell failure particularly in this group.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Impaired glucose tolerance
BMI 16-40 kg/m²

Exclusion Criteria:

chronic disease
anemia
therapy with insulin or cortisone

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869102

Contacts

Contact: Silke A Schäfer, MD	+49 7071 2980590	silke.schaefer@med.uni-tuebingen.de
Contact: Andreas Fritsche, MD	+49 7071 2980590	andreas.fritsche@med.uni-tuebingen.de

Locations

Germany
University of Tübingen
Tübingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

MSD Sharp & Dohme GmbH

More Information

No publications provided

Responsible Party:	UIniversity of Tübingen ( Hans-Ulrich Haering )
Study ID Numbers:	BET-001
Study First Received:	March 23, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00869102 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

IGT
IFG

Study placed in the following topic categories:

Diabetes Mellitus
Glucagon-Like Peptide 1

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on May 07, 2009