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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT00657865
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 41
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ramipril; Drug: placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Ramipril	Drug: ramipril; oral intake
Placebo Comparator: 2 Placebo	Drug: placebo; placebo

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Markus Mueller, Prof. Dr, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT00657865
• Other Study ID Numbers: Ram_Gep_1; 2007-007276-41
• First Posted: Apr 14, 2008
• Last Update Posted: Aug 22, 2011
• Last Verified: Aug 1, 2011

• Additional relevant MeSH terms: Ramipril

Study Results

No Results Posted as of Aug 22, 2011