N-Acetylcysteine and Arginine Administration in Diabetic Patients
NCT ID: NCT00569465
Last Updated: 2007-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
24 participants
INTERVENTIONAL
2005-01-31
2006-01-31
Brief Summary
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Aim of the study is to evaluate the effect of arginine and N-acetylcysteine administration on arterial blood pressure and different metabolic parameters in patients with type 2 diabetes mellitus and hypertension.
Subjects and methods. 24 male subjects, randomly divided in two groups, will be studied. These subjects will undergo a treatment with arginine (1200 mg once a day) plus N-acetylcysteine (600 mg twice a day) or placebo for six months. Basal and final evaluations include:
* general examination
* ABPM (ambulatory blood pressure monitoring)
* HbA1c, total-cholesterol, HDL-cholesterol, LDL-cholesterol, oxidized LDLs, triglycerides, reduced/oxidized glutathione ratio in red blood cells, nitrites/nitrates, asymmetrical and symmetrical dimethyl-arginine, nitrotyrosine, arginine, homocysteine, C-reactive protein, interleukin-6, tumor necrosis factor-α, intercellular and vascular-cell adhesion molecules, plasminogen activator inhibitor-1 and fibrinogen
* the ultrasound assessment of the intima-media thickness after endothelium-dependent flow-mediated vasodilation of the brachial artery
Expected results. Increase of nitric oxide production and reduction of arterial blood pressure and oxidative parameters.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Placebo
3 vials a day
B
Arginine
1200 mg, once a day
Acetylcysteine
600 mg twice a day
Interventions
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Arginine
1200 mg, once a day
Acetylcysteine
600 mg twice a day
Placebo
3 vials a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 40 and 70 years
* Type 2 diabetes mellitus and hypertension
* Mean 24h arterial blood pressure after the wash-out period: systolic \>136mmHg and/or diastolic \>86 mmHh
* Written informed consent
Exclusion Criteria
* Mean 24h arterial blood pressure after the wash-out period: systolic \>180 mmHg and/or diastolic \>110 mmHg
* Secondary hypertension
* Significative cardiovascular complications of diabetes
* Cancer or severe systemic, hepatic, pulmonary, cardiovascular or diseases
* Actual treatment with nitrates, acetylcysteine or arginine
* Acetylcysteine hypersensitivity
* Psychiatric disturbs, abuse of drugs or alcohol
* Low compliance
* Absence of written informed consent
40 Years
70 Years
MALE
No
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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University of Turin
Principal Investigators
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Valentino Martina, MD
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Locations
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"San Giovanni Battista" Hospital of Turin
Turin, Turin, Italy
Countries
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Other Identifiers
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EUDRACT 2004-004203-38
Identifier Type: -
Identifier Source: org_study_id