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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00657865

Enrollment

Registered

2008-04-14

Start date

2008-03-31

Completion date

2011-08-31

Last updated

2011-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGramipril

oral intake

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

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)

Design outcomes

Primary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026