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N-Acetylcysteine and Arginine Administration in Diabetic Patients (NACARGPAO)

This study has been terminated.
(End of the study)
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00569465
First received: December 6, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

December 6, 2007
December 6, 2007
January 2005
Not Provided
arterial blood pressure decrease [ Time Frame: 6 months ]
Same as current
No Changes Posted
oxidative parameters decrease [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
N-Acetylcysteine and Arginine Administration in Diabetic Patients
Effects of Arginine and N-Acetylcysteine Administration on Nitric Oxide Production and Arterial Blood Pressure in Hypertensive Diabetic Patients.

It has been demonstrated that the nitric oxide production is reduced in type 2 diabetic patients and that cardiovascular complications represent 80% of the causes of death in these patients. As nitric oxide is able to reduce platelet aggregation, increase the relaxation of smooth muscle cells, and reduce plasminogen activator inhibitor-1 and endothelin, we hypothesized that nitric oxide deficiency is responsable for the cardiovascular disease in type 2 diabetes mellitus. Arginine and N-acetylcysteine, precursor and enhancer of the nitric oxide synthesis respectively, are able to increase nitric oxide production.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Hypertension
  • Drug: Arginine
    1200 mg, once a day
    Other Name: Zentrum
  • Drug: Acetylcysteine
    600 mg twice a day
    Other Name: Acetilcisteina
  • Drug: Placebo
    3 vials a day
  • Placebo Comparator: A
    Intervention: Drug: Placebo
  • Experimental: B
    Interventions:
    • Drug: Arginine
    • Drug: Acetylcysteine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
January 2006
Not Provided

Inclusion Criteria:

  • Male subjects
  • 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:

  • Female subjects
  • 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
Sexes Eligible for Study: Male
40 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00569465
EUDRACT 2004-004203-38
No
Not Provided
Not Provided
Not Provided
Prof. Valentino Martina, University of Turin
University of Turin, Italy
Not Provided
Principal Investigator: Valentino Martina, MD University of Turin, Italy
University of Turin, Italy
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP