Effect of Rosiglitazone

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT00285142
First received: January 31, 2006
Last updated: October 5, 2006
Last verified: January 2006
  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: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Assessment of the Effect of Rosiglitazone on Insulin Secretion in Healthy Volunteers

Resource links provided by NLM:


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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00285142     History of Changes
Other Study ID Numbers: UF7715
Study First Received: January 31, 2006
Last Updated: October 5, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on April 21, 2014