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Characterization of Beta Cell Failure

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00869102
Enrollment
0
Registered
2009-03-25
Start date
2009-05-31
Completion date
2011-12-31
Last updated
2014-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Metabolic Syndrome

Keywords

IGT, IFG

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.

Interventions

DRUGGLP-1

intravenous, 124,5 pmol/kg body weight

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* chronic disease * anemia * therapy with insulin or cortisone

Design outcomes

Primary

MeasureTime frame
Insulin secretion1 day

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026