Status:
UNKNOWN
Type 2 Diabetes Mellitus and Atherosclerosis
Lead Sponsor:
University of Roma La Sapienza
Collaborating Sponsors:
University of Rome Tor Vergata
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
In individuals with Type 2 Diabetes (T2D) it has been obtained an outstanding improvement in the management of hyperglycemia, but it has not been achieved a similar result in the reduction of the athe...
Detailed Description
Study design: prospective, controlled, randomized study. All eligible patients will be randomly assigned in a 1:1 manner to receive aspirin or placebo. In each recruited subjects we will do: 1. Anam...
Eligibility Criteria
Inclusion
- Type 2 Diabetes Mellitus (defined according to the criteria of the American Diabetes Association)
- Sign of a written informed consent to participate to the interventional study
Exclusion
- Liver disease
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01250340
Start Date
August 1 2010
End Date
December 1 2012
Last Update
November 28 2012
Active Locations (1)
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1
Sapienza Università di Roma
Rome, Italy, Italy, 00161