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

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

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

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

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