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
Recruitment status was Not yet recruiting
Sponsor:
Assaf-Harofeh Medical Center
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
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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
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 Diabetes Mellitus Diabetes Mellitus, Type 2 Arteriosclerosis 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 May 19, 2013