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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: ramipril; Drug: placebo

• Registration Number: NCT00657865
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Primary Completion: 2010-03
• Status Verified: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-19
• Last Update Posted: 2011-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ramipril	Ramipril
2	placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.	1 year

Trial Locations

Locations (1)

Medical University Vienna, Department of Clinical Pharacology; 🇦🇹 Vienna, Austria