Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.

Technische Universität Dresden

Status: Completed

Conditions: Healthy Subjects

Treatments: Drug: rosiglitazone (drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT00154011

IKPD 01-05

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind