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

Study Description

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 Design

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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

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

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

Criteria

Inclusion Criteria:

BMI between 18.0 and 24.0

Exclusion Criteria:

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00285142

Locations

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France
Centre d'Investigation Clinique
Montpellier, France, 34295, cedex 5

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

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Principal Investigator:	PIERRE PETIT, MD-PhD	Centre d'Investigation Clinique

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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ClinicalTrials.gov Identifier:	NCT00285142
Other Study ID Numbers:	7715
First Posted:	February 1, 2006 Key Record Dates
Last Update Posted:	June 10, 2019
Last Verified:	January 2006

Keywords provided by University Hospital, Montpellier:


rosiglitazone insulin secretion clinical trial healthy persons

Additional relevant MeSH terms:

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Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs

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