N-Acetylcysteine and Arginine Administration in Diabetic Patients

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Prijava / prijava

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StanjePrenehala

Sponzorji

University of Turin, Italy

KLINIČNO PRESKUŠANJE: NCT00569465

BioSeek: nct00569465

Ključne besede

Povzetek

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.

Datumi

Nazadnje preverjeno:	11/30/2007
Prvič predloženo:	12/05/2007
Predviden vpis oddan:	12/05/2007
Prvič objavljeno:	12/06/2007
Zadnja posodobitev oddana:	12/05/2007
Zadnja posodobitev objavljena:	12/06/2007
Dejanski datum začetka študija:	12/31/2004
Predvideni datum zaključka študije:	12/31/2005

Stanje ali bolezen

Type 2 Diabetes Mellitus

Hypertension

Intervencija / zdravljenje

Drug: B

Drug: A

Faza

Faza 4

Skupine rok

Roka	Intervencija / zdravljenje
Placebo Comparator: A	Drug: A 3 vials a day
Experimental: B	Drug: B 1200 mg, once a day

Merila upravičenosti

Starost, primerna za študij	40 Years Za 40 Years
Spol, upravičen do študija	Male
Sprejema zdrave prostovoljce	Da
Merila	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

Izid

Primarni izidni ukrepi

1. arterial blood pressure decrease [6 months]

Ukrepi sekundarnega rezultata

1. oxidative parameters decrease [6 months]

N-Acetylcysteine and Arginine Administration in Diabetic Patients

Ključne besede

n acetylcysteine

triglyceride

nitrate

rak

nekroza

sladkorna bolezen tipa 2

sladkorna bolezen

glutathione

acetilcistein

arginine