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Effect of Rosiglitazone
This study has been completed.
Sponsored by: 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

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate
U.S. FDA Resources
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

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

Publications indexed to this study:
Study ID Numbers: UF7715
Study First Received: January 31, 2006
Last Updated: October 5, 2006
ClinicalTrials.gov Identifier: NCT00285142  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Montpellier:
rosiglitazone
insulin secretion
clinical trial
healthy
persons

Study placed in the following topic categories:
Healthy
Rosiglitazone
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009