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Characterization of Beta Cell Failure

Primary Purpose

Diabetes, Metabolic Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
GLP-1
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes focused on measuring IGT, IFG

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic disease
  • anemia
  • therapy with insulin or cortisone

Sites / Locations

  • University of Tübingen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GLP-1

Arm Description

Outcomes

Primary Outcome Measures

Insulin secretion

Secondary Outcome Measures

Full Information

First Posted
March 23, 2009
Last Updated
July 30, 2014
Sponsor
University Hospital Tuebingen
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00869102
Brief Title
Characterization of Beta Cell Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Withdrawn
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Metabolic Syndrome
Keywords
IGT, IFG

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLP-1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GLP-1
Intervention Description
intravenous, 124,5 pmol/kg body weight
Primary Outcome Measure Information:
Title
Insulin secretion
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Impaired glucose tolerance BMI 16-40 kg/m² Exclusion Criteria: chronic disease anemia therapy with insulin or cortisone
Facility Information:
Facility Name
University of Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

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Characterization of Beta Cell Failure

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