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Characterization of Beta Cell Failure

This study has been withdrawn prior to enrollment.
Merck Sharp & Dohme Corp.
Information provided by:
University Hospital Tuebingen Identifier:
First received: March 23, 2009
Last updated: July 30, 2014
Last verified: March 2009
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Insulin secretion [ Time Frame: 1 day ]

Enrollment: 0
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
Experimental: GLP-1 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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Impaired glucose tolerance
  • BMI 16-40 kg/m²

Exclusion Criteria:

  • chronic disease
  • anemia
  • therapy with insulin or cortisone
  Contacts and Locations
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Please refer to this study by its identifier: NCT00869102

University of Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Hans-Ulrich Haering, UIniversity of Tübingen Identifier: NCT00869102     History of Changes
Other Study ID Numbers: BET-001
Study First Received: March 23, 2009
Last Updated: July 30, 2014

Keywords provided by University Hospital Tuebingen:

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on September 21, 2017