Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
2 other identifiers
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 healthy
Started Mar 2008
Longer than P75 for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 22, 2011
August 1, 2011
2 years
April 8, 2008
August 19, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.
1 year
Study Arms (2)
1
ACTIVE COMPARATORRamipril
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Vienna, Department of Clinical Pharacology
Vienna, Vienna, 1090, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus Mueller, MD
Medical University of Vienna, Dep. of Clinical Pharmacology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr
Study Record Dates
First Submitted
April 8, 2008
First Posted
April 14, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2010
Study Completion
August 1, 2011
Last Updated
August 22, 2011
Record last verified: 2011-08