Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.
Information source: Dresden University of Technology
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects
Intervention: rosiglitazone (drug) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Dresden University of Technology Official(s) and/or principal investigator(s):
Wilhelm Kirch, MD, Study Chair, Affiliation: Institute of Clinical Pharmacology
Summary
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.
Clinical Details
Official title:
Characterization of Vascular Effects of Rosiglitazone.
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Vascular reactivity after 8 weeks treatment.
Secondary outcome: Changes in angiotensin peptide metabolism.
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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Male.
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
Locations and Contacts
Institute of Clinical Pharmacology, Dresden 01307, Germany
Additional Information
Starting date:
September 2005
Ending date: June 2006
Last updated: September 11, 2006
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