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Sponsors and Collaborators: |
University Hospital Tuebingen MSD Sharp & Dohme GmbH |
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Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00869102 |
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 |
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Diabetes Metabolic Syndrome |
Drug: GLP-1 |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Single Group Assignment |
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 |
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GLP-1: Experimental |
Drug: GLP-1
intravenous, 124,5 pmol/kg body weight
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Germany | |
University of Tübingen | |
Tübingen, Germany, 72076 |
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 |
IGT IFG |
Diabetes Mellitus Glucagon-Like Peptide 1 |
Pathologic Processes Disease Syndrome |