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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00569465
Recruitment Status : Terminated (End of the study)
First Posted : December 7, 2007
Last Update Posted : December 7, 2007
Sponsor:
Information provided by:
University of Turin, Italy

Tracking Information
First Submitted Date  ICMJE December 6, 2007
First Posted Date  ICMJE December 7, 2007
Last Update Posted Date December 7, 2007
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2007)
arterial blood pressure decrease [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2007)
oxidative parameters decrease [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE N-Acetylcysteine and Arginine Administration in Diabetic Patients
Official Title  ICMJE Effects of Arginine and N-Acetylcysteine Administration on Nitric Oxide Production and Arterial Blood Pressure in Hypertensive Diabetic Patients.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: A
    Intervention: Drug: Placebo
  • Experimental: B
    Interventions:
    • Drug: Arginine
    • Drug: Acetylcysteine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 6, 2007)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00569465
Other Study ID Numbers  ICMJE EUDRACT 2004-004203-38
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Valentino Martina, University of Turin
Study Sponsor  ICMJE University of Turin, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Valentino Martina, MD University of Turin, Italy
PRS Account University of Turin, Italy
Verification Date December 2007

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