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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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
oxidative parameters decrease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
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
Male
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00569465
EUDRACT 2004-004203-38
No
Prof. Valentino Martina, University of Turin
University of Turin, Italy
Not Provided
Principal Investigator: Valentino Martina, MD University of Turin
University of Turin, Italy
December 2007

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