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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00732407
First received: August 10, 2008
Last updated: August 11, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Atherosclerosis
Drug: aliskiren
Drug: losartan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Effect of Aliskiren on Arterial Stiffness and Platelet Function in Patients With Type 2 Diabetes Mellitus, a Comparison With Losartan

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • arterial stiffness and platelet function [ Time Frame: 6.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • oxidative stress parameters (oxidized LDL and Isoprostanes), markers of inflammatory status (highly sensitive CRP test) and 24 hours blood pressure monitoring [ Time Frame: 6.5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients with diabetes melittus treated with an ACE inhibitor will be treated with aliskiren
Drug: aliskiren
Aliskiren will be given in a preliminary dosage of 150 mg per day, after a follow up of two weeks dosage will be increased to 300 mg per day.
Drug: losartan
Losartan will be given in a preliminary dosage of 50 mg per day and after a two weeks follow up dosage will be increased to 100 mg per day
Experimental: 2
Patients with diabetes melittus treated with an ACE inhibitor will be given losartan
Drug: aliskiren
Aliskiren will be given in a preliminary dosage of 150 mg per day, after a follow up of two weeks dosage will be increased to 300 mg per day.
Drug: losartan
Losartan will be given in a preliminary dosage of 50 mg per day and after a two weeks follow up dosage will be increased to 100 mg per day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732407

Contacts
Contact: Ronit Koren Peleg, MD 972-524-535024 ronitkoren@gmail.com
Contact: Shai Efrati, MD 972-577-346-364 efratishai@013.net

Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Ronit Koren Peleg, MD Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel
  More Information

No publications provided

Responsible Party: Koren Peleg Ronit MD, Assaf-Harofeh Medical Center internal medicine A
ClinicalTrials.gov Identifier: NCT00732407     History of Changes
Other Study ID Numbers: ronit2
Study First Received: August 10, 2008
Last Updated: August 11, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:
aliskiren
arteial stiffness
platelet function
diabetes mellitus

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014