Healthy Subjects
Conditions
Keywords
vascular reactivity, venodilation
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.
Interventions
DRUGrosiglitazone (drug)
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular reactivity after 8 weeks treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in angiotensin peptide metabolism. | — |
Countries
Germany
Outcome results
None listed