Characterization of Beta Cell Failure

NCT ID: NCT00869102

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Metabolic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GLP-1

Group Type EXPERIMENTAL

GLP-1

Intervention Type DRUG

intravenous, 124,5 pmol/kg body weight

Interventions

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GLP-1

intravenous, 124,5 pmol/kg body weight

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* chronic disease
* anemia
* therapy with insulin or cortisone
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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UIniversity of Tübingen

Locations

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University of Tübingen

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BET-001

Identifier Type: -

Identifier Source: org_study_id

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