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

This study is currently recruiting participants.

Verified by Medical University of Vienna, April 2008

First Received: April 8, 2008 Last Updated: April 11, 2008 History of Changes

Sponsor:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00657865

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: ramipril Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment
Official Title:	Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

Drug Information available for: Ramipril

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: ramipril oral intake
2: Placebo Comparator	Drug: placebo placebo

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657865

Contacts

Contact: Martin Brunner, MD	00431404002981	martin.brunner@meduniwien.ac.at
Contact: Robert Sauermann, MD	00431404002981	robert.sauermann@meduniwien.ac.at

Locations

Austria
Medical University Vienna, Department of Clinical Pharacology	Recruiting
Vienna, Austria, 1090
Contact: Robert Sauermann, MD 0043-1-40400-2981 robert.sauermann@meduniwien.ac.at
Contact: Martin Brunner, MD 0043-1-40400-2981 martin.brunner@meduniwien.ac.at
Principal Investigator: Markus Mueller, MD

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Markus Mueller, MD

Medical University of Vienna, Dep. of Clinical Pharmacology

More Information

No publications provided

Responsible Party:	Medical University of Vienna, Departement of Clinical Pharmacology ( Markus Müller )
Study ID Numbers:	Ram_Gep_1, 2007-007276-41
Study First Received:	April 8, 2008
Last Updated:	April 11, 2008
ClinicalTrials.gov Identifier:	NCT00657865 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Ramipril
Protease Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010