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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014