Effect of Rosiglitazone

This study has been completed.

First Received: January 31, 2006 Last Updated: October 5, 2006 History of Changes

Sponsor:	University Hospital, Montpellier
Information provided by:	University Hospital, Montpellier
ClinicalTrials.gov Identifier:	NCT00285142

Purpose

To evaluate :

acute effects of a single dose of 8 mg rosiglitazone (therapeutic dose)
on insulin secretion and
insulin sensitivity in 12 healthy male subjects.

Condition	Intervention
Healthy	Drug: rosiglitazone

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Assessment of the Effect of Rosiglitazone on Insulin Secretion in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:

insulin response and insulin sensitivity assessed by 2-hours 10 mmol/l hyperglycemic clamp, started 45 min after treatment intake

Secondary Outcome Measures:

insulin clearance
basal glycemia and insulinemia
tolerance

Estimated Enrollment:	12
Study Start Date:	June 2004
Estimated Study Completion Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

BMI between 18.0 and 24.0

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285142

Locations

France
Centre d'Investigation Clinique
Montpellier, France, 34295, cedex 5

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Principal Investigator:

PIERRE PETIT, MD-PhD

Centre d'Investigation Clinique

More Information

No publications provided by University Hospital, Montpellier

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Farret A, Chevassus H, Roux B, Petit P, Galtier F. Direct rosiglitazone-induced modifications in insulin secretion, action and clearance: a single-dose hyperglycaemic clamp study. Diabetologia. 2007 Jul;50(7):1384-7. Epub 2007 May 8.

Study ID Numbers:	UF7715
Study First Received:	January 31, 2006
Last Updated:	October 5, 2006
ClinicalTrials.gov Identifier:	NCT00285142 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Montpellier:

rosiglitazone
insulin secretion
clinical trial
healthy
persons

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010