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Effect of Rosiglitazone

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ClinicalTrials.gov Identifier: NCT00285142
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : June 10, 2019
Sponsor:
Information provided by:
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE January 31, 2006
First Posted Date  ICMJE February 1, 2006
Last Update Posted Date June 10, 2019
Study Start Date  ICMJE June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
insulin response and insulin sensitivity assessed by 2-hours 10 mmol/l hyperglycemic clamp, started 45 min after treatment intake
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
  • insulin clearance
  • basal glycemia and insulinemia
  • tolerance
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Rosiglitazone
Official Title  ICMJE Assessment of the Effect of Rosiglitazone on Insulin Secretion in Healthy Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: rosiglitazone
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 31, 2006)
12
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI between 18.0 and 24.0

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00285142
Other Study ID Numbers  ICMJE 7715
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: PIERRE PETIT, MD-PhD Centre d'Investigation Clinique
PRS Account University Hospital, Montpellier
Verification Date January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP