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

NCT00732407 | Unknown

• 1 other identifier: ronit2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.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.

Conditions

Diabetes Mellitus; Atherosclerosis

Keywords

aliskiren; arteial stiffness; platelet function; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• arterial stiffness and platelet function

  6.5 months

Secondary Outcomes (1)

• oxidative stress parameters (oxidized LDL and Isoprostanes), markers of inflammatory status (highly sensitive CRP test) and 24 hours blood pressure monitoring

  6.5 months

Study Arms (2)

1

EXPERIMENTAL

Patients with diabetes melittus treated with an ACE inhibitor will be treated with aliskiren

Drug: aliskiren; Drug: losartan

2

EXPERIMENTAL

Patients with diabetes melittus treated with an ACE inhibitor will be given losartan

Drug: aliskiren; Drug: losartan

Interventions

losartan DRUG

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

1; 2

aliskiren DRUG

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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients will be excluded from the study if their systolic BP is between bellow 110 mmHg or above 150 mmHg mmHg.
• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

MeSH Terms

Conditions

Diabetes Mellitus; Atherosclerosis

Interventions

aliskiren; Losartan

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronit Koren Peleg, MD

CONTACT

972-524-535024; ronitkoren@gmail.com

Shai Efrati, MD

CONTACT

972-577-346-364; efratishai@013.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 10, 2008
• First Posted: August 12, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Last Updated: August 12, 2008

Record last verified: 2008-08