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

August 19, 2011 updated by: Markus Mueller, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Placebo
Drug: placebo
placebo
ACTIVE_COMPARATOR: 1
Ramipril
Drug: ramipril
oral intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (ESTIMATE)

April 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2011

Last Update Submitted That Met QC Criteria

August 19, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ram_Gep_1
  • 2007-007276-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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