Official Title: “Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril”

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.

Study Type: Interventional

Study Design: Basic Science, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: ramipril
  • oral intake
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.
  • Time Frame: 1 year
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Medical University of Vienna

Overall Clinical Trial Officials and Contacts

Markus Mueller, MD Principal Investigator Medical University of Vienna, Dep. of Clinical Pharmacology  

Overall Contact: Martin Brunner, MD 00431404002981 martin.brunner@meduniwien.ac.at

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00657865

Study ID Number: Ram_Gep_1

ClinicalTrials.gov Identifier: NCT00657865

Health Authority: Austria: Agency for Health and Food Safety