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Characterization of Beta Cell Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University Hospital Tuebingen.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00869102
First received: March 23, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:

U.S. FDA Resources

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
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

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 Not yet recruiting
Tübingen, Germany, 72076
Contact: Silke A Schäfer, MD     +49 70701 209ß590     silke.schafer@med.uni-tuebingen.de    
Principal Investigator: Andreas Fritsche, MD            
Sponsors and Collaborators
University Hospital Tuebingen
Merck
  More Information

No publications provided

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

Keywords provided by University Hospital Tuebingen:
IGT
IFG

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

ClinicalTrials.gov processed this record on June 18, 2013