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Characterization of Beta Cell Failure

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869102
First Posted: March 25, 2009
Last Update Posted: July 31, 2014
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University Hospital Tuebingen
  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

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.

  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic disease
  • anemia
  • therapy with insulin or cortisone
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00869102


Locations
Germany
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
ClinicalTrials.gov Identifier: NCT00869102     History of Changes
Other Study ID Numbers: BET-001
First Submitted: March 23, 2009
First Posted: March 25, 2009
Last Update Posted: July 31, 2014
Last Verified: March 2009

Keywords provided by University Hospital Tuebingen:
IGT
IFG

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