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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657865
• Other study ID #: Ram_Gep_1
• Secondary ID: 2007-007276-41
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2008
• Last updated: August 19, 2011
• Start date: March 2008
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ramipril
oral intake
• placebo
placebo

Locations

Country	Name	City	State
Austria	Medical University Vienna, Department of Clinical Pharacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.		1 year	No