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

This study has been completed.

First Received on April 8, 2008. Last Updated on August 19, 2011 History of Changes

Sponsor:	Medical University of Vienna
Information provided by (Responsible Party):	Markus Mueller, 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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
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 ]

Enrollment:	18
Study Start Date:	March 2008
Study Completion Date:	August 2011
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

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

Locations

Austria
Medical University Vienna, Department of Clinical Pharacology
Vienna, Austria, 1090

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:	Markus Mueller, Prof. Dr, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00657865 History of Changes
Other Study ID Numbers:	Ram_Gep_1, 2007-007276-41
Study First Received:	April 8, 2008
Last Updated:	August 19, 2011
Health Authority:	Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:

Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012