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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Ramipril

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 <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)