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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Markus Mueller, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00657865
First received: April 8, 2008
Last updated: August 19, 2011
Last verified: August 2011
History of Changes
  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 4

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:

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 May 16, 2013