Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril

Medical University of Vienna

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Drug: placebo

Drug: ramipril

Study type

Interventional

Funder types

Other

Identifiers

NCT00657865

Ram_Gep_1

2007-007276-41

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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 <140/90 (twice at screening)

Exclusion criteria

History of renal artery stenosis
- angioneurotic edema
- psoriasis
- relevant renal diseases
RR at screening < 110/45 mmHg.
Diabetes, history of hypertension, RR > 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 3 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)