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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007276-41 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ramipril |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ramipril | Drug | oral intake |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
History of renal artery stenosis
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)
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| Name | Affiliation | Role |
|---|---|---|
| Markus Mueller, MD | Medical University of Vienna, Dep. of Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna, Department of Clinical Pharacology | Vienna | State of Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
placebo |
|