N-Acetylcysteine and Arginine Administration in Diabetic Patients (NACARGPAO)
Primary Purpose
Type 2 Diabetes Mellitus, Hypertension
Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Arginine
Acetylcysteine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring nitric oxide, oxidative stress, diabetes, hypertension, endothelial dysfunction
Eligibility Criteria
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
Sites / Locations
- "San Giovanni Battista" Hospital of Turin
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
arterial blood pressure decrease
Secondary Outcome Measures
oxidative parameters decrease
Full Information
NCT ID
NCT00569465
First Posted
December 6, 2007
Last Updated
December 6, 2007
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT00569465
Brief Title
N-Acetylcysteine and Arginine Administration in Diabetic Patients
Acronym
NACARGPAO
Official Title
Effects of Arginine and N-Acetylcysteine Administration on Nitric Oxide Production and Arterial Blood Pressure in Hypertensive Diabetic Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Why Stopped
End of the study
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Turin, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hypertension
Keywords
nitric oxide, oxidative stress, diabetes, hypertension, endothelial dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Arginine
Other Intervention Name(s)
Zentrum
Intervention Description
1200 mg, once a day
Intervention Type
Drug
Intervention Name(s)
Acetylcysteine
Other Intervention Name(s)
Acetilcisteina
Intervention Description
600 mg twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 vials a day
Primary Outcome Measure Information:
Title
arterial blood pressure decrease
Time Frame
6 months
Secondary Outcome Measure Information:
Title
oxidative parameters decrease
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentino Martina, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
"San Giovanni Battista" Hospital of Turin
City
Turin
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
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N-Acetylcysteine and Arginine Administration in Diabetic Patients
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