healthy young males
Conditions
Interventions
Trade Name: Tritace
Pharmaceutical Form: Tablet
INN or Proposed INN: ramipril
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Male • Healthy defined as absence of relevant disease • Caucasian • Aged 18-45 years • BMI: 18-28 kg/m2 • Signed informed consent • Blood pressure between 110/45 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • History of renal artery stenosis, angioneurotic edema, psoriasis, relevant renal diseases • RR at screening 140/90 at screening, cardiovascular disease • Known Diabetes mellitus of parents • HIV or Hepatitis B/C positive virology • Allergy or hypersensitivity against ACE-inhibitors / ramipril or to xylocain • Contraindications against the use of the drug according to the SmPC, history of angioedema • Any drug intake 2 weeks prior to first study day • History of excessive bleeding tendency / hemophilia • Presence of relevant illness within the last 3 weeks • Suspected non-compliance with study instructions and life-style requirements • Alcohol or drug abuse • Blood/Plasma donation within 4 weeks prior to study day • Previous exposure to antihypertensive drugs, ACE-inhibitors, in particular ramipril • Current smoking (any quantity), (at least 6 months of non-smoking required)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Rationale for the study: This project investigates the effect of ACE-inhibition on cellular metabolism by gene expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril intake. This should contribute to our understanding of the pathomechanisms involved in diabetes and the clinical effect of ACE-inhibition on patients with diabetes/metabolic syndrome. Aims of the study: To identify and describe metabolic/signaling pathways in muscle tissue which are affected or induced by ACE-inhibition. This might help to identify targets which could serve as early molecular markers of metabolic disease and success of therapy applicable in a clinical setting. ;Secondary Objective: none;Primary end point(s): Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake. Effects common to all subjects as well as intra-individual differences will be identified and analyzed. Study goal is identification of genes encoding e.g. metabolic proteins, whose expression in muscle tissue is modified by ramipril. Optional outcome parameters: Previously described single nucleotide polymorphisms in genes of the renin-angiotensin-aldosterone system may be determined from stored blood optionally if further clarification is requested to interpret potential inter-individual differences of gene expression profiles. | — |
Countries
Austria
Outcome results
None listed