NCT00285142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
Last Updated

June 10, 2019

Status Verified

January 1, 2006

First QC Date

January 31, 2006

Last Update Submit

June 7, 2019

Conditions

Healthy

Keywords

rosiglitazoneinsulin secretionclinical trialhealthypersons

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • insulin clearance

  • basal glycemia and insulinemia

  • tolerance

Interventions

rosiglitazoneDRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18.0 and 24.0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique

Montpellier, 34295, cedex 5, France

Location

Related Publications (1)

  • 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.

    PMID: 17486315DERIVED

MeSH Terms

Interventions

Rosiglitazone

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • PIERRE PETIT, MD-PhD

    Centre d'Investigation Clinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 1, 2006

Study Start

June 1, 2004

Study Completion

November 1, 2004

Last Updated

June 10, 2019

Record last verified: 2006-01

Locations

FR(1)