Effect of Rosiglitazone
Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT00285142
Collaborator
(none)
12
1
5
2.4
Study Details
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 |
|---|---|---|
| N/A |
Study Design
Study Type:
Interventional
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
:
Jun 1, 2004
Study Completion Date
:
Nov 1, 2004
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
Criteria
Ages Eligible for Study:
18 Years
to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- BMI between 18.0 and 24.0
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre d'Investigation Clinique | Montpellier | France | 34295, cedex 5 |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
- Principal Investigator: PIERRE PETIT, MD-PhD, Centre d'Investigation Clinique
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00285142
Other Study ID Numbers:
- 7715
First Posted:
Feb 1, 2006
Last Update Posted:
Jun 10, 2019
Last Verified:
Jan 1, 2006
Keywords provided by ,
,
Additional relevant MeSH terms: