N-Acetylcysteine and Arginine Administration in Diabetic Patients

Hypertension Clinical Trial

— NACARGPAO  

Official title:

Effects of Arginine and N-Acetylcysteine Administration on Nitric Oxide Production and Arterial Blood Pressure in Hypertensive Diabetic Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00569465
• Other study ID #: EUDRACT 2004-004203-38
• Status: Terminated
• Phase: Phase 4
• First received: December 6, 2007
• Last updated: December 6, 2007
• Start date: January 2005
• Est. completion date: January 2006

Study information

• Verified date: December 2007
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Arginine
1200 mg, once a day
• Acetylcysteine
600 mg twice a day
• Placebo
3 vials a day

Locations

Country	Name	City	State
Italy	"San Giovanni Battista" Hospital of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial blood pressure decrease		6 months	No
Secondary	oxidative parameters decrease		6 months	No