Characterization of Beta Cell Failure

Diabetes Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00869102
• Other study ID #: BET-001
• Status: Withdrawn
• Phase: N/A
• First received: March 23, 2009
• Last updated: July 30, 2014
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2009
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Impaired glucose tolerance

• BMI 16-40 kg/m²

Exclusion Criteria:

• chronic disease

• anemia

• therapy with insulin or cortisone

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• GLP-1
intravenous, 124,5 pmol/kg body weight

Locations

Country	Name	City	State
Germany	University of Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin secretion		1 day	No