Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.

This study has been completed.

First Received: September 8, 2005 Last Updated: September 11, 2006 History of Changes

Sponsor:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00154011

Purpose

The study is designed to test the hypothesis in healthy subjects that the oral antidiabetic drug rosiglitazone provides additional vascular relaxing or modulating effects in addition to its blood glucose level reducing ability.

Condition	Intervention
Healthy Subjects	Drug: rosiglitazone (drug)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Characterization of Vascular Effects of Rosiglitazone.

Resource links provided by NLM:

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Vascular reactivity after 8 weeks treatment.

Secondary Outcome Measures:

Changes in angiotensin peptide metabolism.

Estimated Enrollment:	24
Study Start Date:	September 2005
Estimated Study Completion Date:	June 2006

Detailed Description:

The aim of the study is to investigate the effect of oral rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Rosiglitazone will be given orally (4 weeks 4mg/d, titrated to 8 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with rosiglitazone.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male
Healthy
18 - 40 years old
Non-smoker
No additional medication

Exclusion Criteria:

Any relevant disease
Smokers
Elevated liver enzymes
Body weight different from Broca norm > 20%
Allergies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154011

Locations

Germany
Institute of Clinical Pharmacology
Dresden, Germany, 01307

Sponsors and Collaborators

Dresden University of Technology

Investigators

Study Chair:

Wilhelm Kirch, MD

Institute of Clinical Pharmacology

More Information

No publications provided

Study ID Numbers:	IKPD 01-05
Study First Received:	September 8, 2005
Last Updated:	September 11, 2006
ClinicalTrials.gov Identifier:	NCT00154011 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

vascular reactivity, venodilation

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010