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


Phase 4
40 Years
70 Years
Not Enrolling
Male
Type 2 Diabetes Mellitus, Hypertension

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

arterial blood pressure decrease

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Valentino Martina, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Turin

Authority:

Italy: Ethics Committee

Study ID:

EUDRACT 2004-004203-38

NCT ID:

NCT00569465

Start Date:

January 2005

Completion Date:

January 2006

Related Keywords:

  • Type 2 Diabetes Mellitus
  • Hypertension
  • nitric oxide
  • oxidative stress
  • diabetes
  • hypertension
  • endothelial dysfunction
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Hypertension

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