N-Acetylcysteine and Arginine Administration in Diabetic Patients
Status:
Terminated
Trial end date:
2006-01-01
Target enrollment:
Participant gender:
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.