Aliskiren's Effect on Arterial Stiffness and Platelet Function in Patients With Diabetes Mellitus (DM)

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.The aim of this study is to investigate the effect of aliskiren on arterial stiffness, platelet function and inflammation compared to losatan in patients with diabetes mellitus.

We hypothesize that aliskiren will have a beneficial effect on arterial stiffness and platelet function in patients with diabetes mellitus.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assaf-Harofeh Medical Center
• Treatments: Losartan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.