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Completed

NCT Number: NCT00657865

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Vienna, Department of Clinical Pharacology

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ramipril

Drug

oral intake

Placebo

Drug

placebo

Primary outcomes

  1. Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Apr 14, 2008
Registry last updated
Aug 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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