Type 2 Diabetes MellitusPhase 4NACARGPAONCT00569465
N-Acetylcysteine and Arginine Administration in Diabetic Patients
A Phase 4 study testing Arginine and Acetylcysteine in people with Type 2 Diabetes Mellitus and Hypertension, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension
- What is being tested?
- Arginine and Acetylcysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2005to Jan 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Acetylcysteine hypersensitivity
- Psychiatric disturbs, abuse of drugs or alcohol
- Low compliance
- Absence of written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Arginine and N-Acetylcysteine Administration on Nitric Oxide Production and Arterial Blood Pressure in Hypertensive Diabetic Patients.
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.
Read more
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.
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Being tested
- Arginine, Acetylcysteine, Placebo
- Keywords
- nitric oxide, oxidative stress, diabetes, hypertension, endothelial dysfunction
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArginineDrug
Also called Zentrum
1200 mg, once a day
AcetylcysteineDrug
Also called Acetilcisteina
600 mg twice a day
PlaceboDrug
3 vials a day
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Placebo |
| B | Experimental | Not described Receives: Drug: Arginine; Drug: Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood pressure decrease
Measured: 6 months
Secondary outcomes (1)
oxidative parameters decrease
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startJan 2005
- Study completionJan 2006
Why it stopped: End of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Valentino Martina, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569465
- Sponsor's protocol ID
- EUDRACT 2004-004203-38
- Acronym
- NACARGPAO
- Status last verified
- Dec 2007
- First submitted
- 6 Dec 2007
- Last updated
- 7 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Arginine and N-Acetylcysteine Administration on Nitric Oxide Production and Arterial Blood Pressure in Hypertensive Diabetic Patients.
- ClinicalTrials.gov ID
- NCT00569465
- Acronym / sponsor ID
- NACARGPAO / EUDRACT 2004-004203-38
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Keywords
- nitric oxide, oxidative stress, diabetes, hypertension, endothelial dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of the study
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jan 2006 (actual)
- First posted
- 7 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Placebo |
| B | Experimental | Drug: Arginine, Drug: Acetylcysteine |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArginineAlso: Zentrum1200 mg, once a day | Drug | B |
| AcetylcysteineAlso: Acetilcisteina600 mg twice a day | Drug | B |
| Placebo3 vials a day | Drug | A |
Primary outcome
arterial blood pressure decrease
Time frame: 6 months
1 secondary outcome
oxidative parameters decrease
Time frame: 6 months
Results and safety
The study was stopped early (reason given: End of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentino Martina, MD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arginine and Acetylcysteine in people with Type 2 Diabetes Mellitus and Hypertension, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: End of the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial blood pressure decrease (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2007.