Healthy Subjects
Conditions
Keywords
vascular reactivity, venodilation, pulse wave velocity
Brief summary
The study is designed to test the hypothesis in healthy subjects that candesartan and pioglitazone provide additional vascular relaxing or modulating effects in addition to their blood-pressure and blood glucose level reducing ability, respectively.
Detailed description
The aim of the study is to investigate the effect of oral candesartan and/ or rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Pioglitazone will be given orally (4 weeks 30mg/d, titrated to 45 mg/d for another 4 weeks). Candesartan will be given orally (4 weeks 8mg/d, titrated to 16 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with phenylephrine, angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with study medication or placebo. In addition, pulse wave velocity will me measured non-invasively before and after treatment.
Interventions
DRUGPioglitazone (drug) and/or candesartan (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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulse wave velocity | — |
| Changes in Angiotensin metabolites | — |
Countries
Germany
Outcome results
None listed