Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.

Not Applicable

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT00154011
• Lead Sponsor: Technische Universität Dresden

Brief 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.

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2006-06
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-11
• Last Update Posted: 2006-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vascular reactivity after 8 weeks treatment.

Secondary Outcome Measures

Name	Time	Method
Changes in angiotensin peptide metabolism.

Trial Locations

Locations (1)

Institute of Clinical Pharmacology; 🇩🇪 Dresden, Germany