Vascular effects of peroxisome proliferator–activated receptor gamma stimulation with rosiglitazone during exogenousely elevated free fatty acid concentrations in healthy volunteers - Rosiglitazone and FFA
- Conditions
- healthy
- Registration Number
- EUCTR2004-002243-27-AT
- Lead Sponsor
- Clinical Pharmacology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 16
- male nonsmokers
- age: 18 to 35 years
- Body mass index between 15th and 85th percentile
- Normal findings in medical history, physical and laboratory examinations including OGTT unless the investigator considers an abnormality to be clinically irrelevant
- written informed consent
- Normal ophthalmic findings, ametropy < 3 Dpt.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceeding the study
- Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
- Treatment in the previous 3 weeks with any drug
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
- Blood donation during the previous 3 weeks
- History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of rosiglitazone on FFA induced endothelial dysfunction in response to locally applied acetylcholine and nitroglycerine as well as on ocular hemodynamics and on insulin resistance measured by a short insulin tolerance test in healthy volunteers.;Secondary Objective: ;Primary end point(s): -Forearm blood flow<br>-Retinal vessels diameter (retinal vessel analyser)<br>-Choroidal blood flow (laser interferometry)<br>
- Secondary Outcome Measures
Name Time Method