Effect of Rosiglitazone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285142
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : October 6, 2006
Information provided by:
University Hospital, Montpellier

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Drug: rosiglitazone Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Assessment of the Effect of Rosiglitazone on Insulin Secretion in Healthy Volunteers
Study Start Date : June 2004
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. insulin response and insulin sensitivity assessed by 2-hours 10 mmol/l hyperglycemic clamp, started 45 min after treatment intake

Secondary Outcome Measures :
  1. insulin clearance
  2. basal glycemia and insulinemia
  3. tolerance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • BMI between 18.0 and 24.0

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00285142

Centre d'Investigation Clinique
Montpellier, France, 34295, cedex 5
Sponsors and Collaborators
University Hospital, Montpellier
Principal Investigator: PIERRE PETIT, MD-PhD Centre d'Investigation Clinique

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00285142     History of Changes
Other Study ID Numbers: UF7715
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: October 6, 2006
Last Verified: January 2006

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

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs