N-Acetylcysteine and Arginine Administration in Diabetic Patients

Phase 4

Terminated

• Conditions: Type 2 Diabetes Mellitus; Hypertension
• Interventions: Drug: Placebo; Drug: Arginine; Drug: Acetylcysteine

• Registration Number: NCT00569465
• Lead Sponsor: University of Turin, Italy

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 available

Study Timeline

• Study Start: 2005-01
• Study Completion: 2006-01
• Status Verified: 2007-12
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-06
• Last Update Submitted: 2007-12-06
• Study First Posted: 2007-12-07
• Last Update Posted: 2007-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Placebo	-
B	Arginine	-
B	Acetylcysteine	-

Primary Outcome Measures

Name	Time	Method
arterial blood pressure decrease	6 months

Secondary Outcome Measures

Name	Time	Method
oxidative parameters decrease	6 months

Trial Locations

Locations (1)

"San Giovanni Battista" Hospital of Turin; 🇮🇹 Turin, Italy