Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2010-08-31
2012-12-31
Brief Summary
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It will be analyzed in isolated platelets from normal controls and/or diabetic patients the production of TxA2, isoprostanes and pro-inflammatory/thrombotic cytokines using aspirin and NADPHoxidase inhibitors.
Detailed Description
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In each recruited subjects we will do:
1. Anamnestic clinical information and Anthropometric measurements
2. Electrocardiogram, echocardiogram and ultrasound assessment of carotid intima-media thickness (IMT) and flow-mediated dilatation (FMD)
3. Ankle-Brachial Index measurement (ABI)
4. blood samples from an antecubital vein after an overnight fast and urine samples at baseline, after 3 days and after 30 days of aspirin (100 mg/day) administration.
Laboratory Methods: Blood samples will be immediately centrifuged at 2,000 rpm for 20 min at 4°C, and the supernatant was collected and stored at -80°C until measurement. All measurements will be done blinded. Samples will be tested in duplicate, and those showing values above the standard curve will be re-tested with appropriate dilutions.Analysis of urinary and platelet isoprostane:Urinary PGF2α-III was measured by a previously described and validated EIA assay method. Ten millilitre urine were extracted on a C-18 SPE column; the purification was tested for recovery by adding a radioactive tracer (tritiated PGF2α-III) (Cayman chemical). The eluates were dried under nitrogen, recovered with 1ml of buffer, and assayed in a PGF2α-III specific EIA kit (Cayman chemical). Urinary PGF2α-III concentration was corrected for recovery and creatinine excretion and expressed as pg/mg of creatinine. PRP was then centrifuged 20 min at 800 g to concentrate platelets and the pellet was suspended in Tyrode buffer to obtain a final platelet concentration of 5x108/mL. PGF2α-III content was measured by a validated EIA assay method as previously described and expressed as pg/mg platelet protein.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aspirin
100 mg/day for 30 days
Aspirin
100 mg/day for 30 days
Placebo
1 cp /day for 30 days
Placebo
1 cp day for 30 days
Interventions
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Aspirin
100 mg/day for 30 days
Placebo
1 cp day for 30 days
Eligibility Criteria
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Inclusion Criteria
* Sign of a written informed consent to participate to the interventional study
Exclusion Criteria
* Serious renal disorders (serum creatinine \>2.5 mg/dL)
* History or evidence of previous major vascular events (myocardial infarction, transient ischemic attack, stroke)
* History of major bleeding
* Autoimmune diseases
* Cancer or present or recent infections
* Use of non-steroidal anti-inflammatory drugs, drugs interfering with cholesterol metabolism, or vitamin supplements or antiplatelet drugs in the previous 30 days
18 Years
80 Years
ALL
No
Sponsors
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University of Rome Tor Vergata
OTHER
University of Roma La Sapienza
OTHER
Responsible Party
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Francesco Violi
Full professor of internal medicine
Principal Investigators
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Francesco Violi
Role: STUDY_CHAIR
Divisione di Prima Clinica Medica - Sapienza University of Rome
Locations
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Sapienza Università di Roma
Rome, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Francesco Violi, Full Prof
Role: primary
Stefania Basili, Ass Prof
Role: backup
References
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Carnevale R, Iuliano L, Nocella C, Bartimoccia S, Trape S, Russo R, Gentile MC, Cangemi R, Loffredo L, Pignatelli P, Violi F; IPINET group. Relationship between platelet and urinary 8-Iso-PGF2alpha levels in subjects with different degrees of NOX2 regulation. J Am Heart Assoc. 2013 Jun 14;2(3):e000198. doi: 10.1161/JAHA.113.000198.
Cangemi R, Pignatelli P, Carnevale R, Nigro C, Proietti M, Angelico F, Lauro D, Basili S, Violi F. Platelet isoprostane overproduction in diabetic patients treated with aspirin. Diabetes. 2012 Jun;61(6):1626-32. doi: 10.2337/db11-1243. Epub 2012 Mar 16.
Other Identifiers
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Diabetes and Oxidative Stress
Identifier Type: -
Identifier Source: org_study_id