Characterization of Beta Cell Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00869102
Recruitment Status : Withdrawn
First Posted : March 25, 2009
Last Update Posted : July 31, 2014
Merck Sharp & Dohme Corp.
Information provided by:
University Hospital Tuebingen

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Metabolic Syndrome Drug: GLP-1 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : May 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: GLP-1 Drug: GLP-1
intravenous, 124,5 pmol/kg body weight

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00869102

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

Responsible Party: Hans-Ulrich Haering, UIniversity of Tübingen Identifier: NCT00869102     History of Changes
Other Study ID Numbers: BET-001
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: March 2009

Keywords provided by University Hospital Tuebingen:

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases