Effect of Rosiglitazone

June 7, 2019 updated by: University Hospital, Montpellier

Assessment of the Effect of Rosiglitazone on Insulin Secretion in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Drug: rosiglitazone

Study Type

Interventional

Enrollment

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Montpellier, France, 34295, cedex 5
    - Centre d'investigation Clinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

BMI between 18.0 and 24.0

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
insulin response and insulin sensitivity assessed by 2-hours 10 mmol/l hyperglycemic clamp, started 45 min after treatment intake

Secondary Outcome Measures

Outcome Measure
insulin clearance
basal glycemia and insulinemia
tolerance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. doi: 10.1007/s00125-007-0682-4. Epub 2007 May 8.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 1, 2006

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

7715

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.