Status:
UNKNOWN
Aliskiren's Effect on Arterial Stiffness and Platelet Function in Patients With Diabetes Mellitus (DM)
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Diabetes Mellitus
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Aliskiren is a novel renin inhibitor approved for the treatment of hypertension. The effect of aliskiren on arterial stiffness, inflammation and oxidative stress has not been fully investigated yet.Th...
Detailed Description
Background: Patients with diabetes mellitus (DM) have an increased risk for atherothrombotic events. Platelets play an important role in cardiovascular disease both in the pathogenesis of atheroscle...
Eligibility Criteria
Inclusion
- The study will include 40 patients aged 18 years or older with DM, defined as patients with fasting plasma glucose above 126 mg/dL or
- symptoms of DM with random blood glucose concentration of above 200 mg/dL, or
- patients treated with oral hypoglycemics or insulin.
- In addition, prior to their enrollment in the study patients' BP will be assessed by 24 hour ambulatory BP monitoring.
- All patients will have to be treated with ACE inhibitors, aspirin and statins for at least one month prior to their enrollment in the study.
- Patients' medication regimen will not be altered during the study period.
- Patients will sign a written informed consent before their inclusion in the study.
Exclusion
- Patients will be excluded from the study if their systolic BP is between bellow 110 mmHg or above 150 mmHg mmHg.
- Major exclusion criteria will be:
- acute coronary syndrome in the 6 months previous to the study,
- renal failure with creatinin levels above 1.5 mg/dL,
- hyperkalemia (K \> 5 mg/dL),
- hematologic or solid malignancies,
- pregnancy
- a platelet count below 100,000.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00732407
Start Date
September 1 2008
Last Update
August 12 2008
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