NCT00869102

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 31, 2014

Status Verified

March 1, 2009

Enrollment Period

1.6 years

First QC Date

March 23, 2009

Last Update Submit

July 30, 2014

Conditions

DiabetesMetabolic Syndrome

Keywords

IGTIFG

Outcome Measures

Primary Outcomes (1)

  • Insulin secretion

    1 day

Study Arms (1)

GLP-1

EXPERIMENTAL
Drug: GLP-1

Interventions

GLP-1DRUG

intravenous, 124,5 pmol/kg body weight

GLP-1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • chronic disease
  • anemia
  • therapy with insulin or cortisone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Diabetes MellitusMetabolic Syndrome

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 25, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

July 31, 2014

Record last verified: 2009-03

Locations

DE(1)