Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: ramipril (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Markus Mueller, MD, Principal Investigator, Affiliation: Medical University of Vienna, Dep. of Clinical Pharmacology
Overall contact:
Martin Brunner, MD, Phone: 00431404002981, Email: martin.brunner@meduniwien.ac.at
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.
Clinical Details
Official title: Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
Study design: Basic Science, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment
Primary outcome: Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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)
Locations and Contacts
Martin Brunner, MD, Phone: 00431404002981, Email: martin.brunner@meduniwien.ac.at
Medical University Vienna, Department of Clinical Pharacology, Vienna 1090, Austria; Recruiting
Robert Sauermann, MD, Phone: 0043-1-40400-2981, Email: robert.sauermann@meduniwien.ac.at
Martin Brunner, MD, Phone: 0043-1-40400-2981, Email: martin.brunner@meduniwien.ac.at
Markus Mueller, MD, Principal Investigator
Additional Information
Starting date: March 2008
Last updated: April 11, 2008
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