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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Hypertension
Drug: Arginine
Drug: Acetylcysteine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Arginine and N-Acetylcysteine Administration on Nitric Oxide Production and Arterial Blood Pressure in Hypertensive Diabetic Patients.

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • arterial blood pressure decrease [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • oxidative parameters decrease [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2005
Study Completion Date: January 2006
Arms Assigned Interventions
Placebo Comparator: A Drug: Placebo
3 vials a day
Experimental: B Drug: Arginine
1200 mg, once a day
Other Name: Zentrum
Drug: Acetylcysteine
600 mg twice a day
Other Name: Acetilcisteina

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569465

Locations
Italy
"San Giovanni Battista" Hospital of Turin
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Investigators
Principal Investigator: Valentino Martina, MD University of Turin
  More Information

No publications provided

Responsible Party: Prof. Valentino Martina, University of Turin
ClinicalTrials.gov Identifier: NCT00569465     History of Changes
Other Study ID Numbers: EUDRACT 2004-004203-38
Study First Received: December 6, 2007
Last Updated: December 6, 2007
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by University of Turin, Italy:
nitric oxide
oxidative stress
diabetes
hypertension
endothelial dysfunction

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014