Atorvastatin, Aspirin, Oxidative Stress, Coagulation and Platelet Activation Indexes
Type 2 Diabetes Mellitus, Hypercholesterolemia
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Thromboxane, Aspirin, Atorvastatin, Platelet activation, Thrombin Activation, Oxidative stress
Eligibility Criteria
For Hypercholesterolemic patients:
Inclusion Criteria:
- Patients with polygenic hypercholesterolemia (LDL-C > 160 mg/dl)
- Males and Females
- White race
- Sign of the informed consent
Exclusion Criteria:
- Liver insufficiency
- Serious renal disorders
- Diabetes mellitus
- Arterial hypertension
- History or evidence of previous myocardial infarction or other atherothrombotic diseases
- Any autoimmune diseases
- Cancer
- Present or recent infections
- Patients were taking nonsteroidal antiinflammatory drugs, drugs interfering with cholesterol metabolism, or vitamin supplements
For T2 Diabetic patients:
Inclusion Criteria:
- Patients with T2DM diagnosed according to the American Diabetes Association definition
- Treatment with 100 mg/day aspirin from at least 30 days
- Males and Females
- White race
- Sign of the informed consent
Exclusion Criteria:
- recent history (< 3 months) of acute vascular events
- clinical diagnosis of type 1 DM
- serum creatinine level greater than 2.5 mg/dl
- active infection or malignancy
- cardiac arrhythmia or congestive heart failure
- use of non-steroidal anti-inflammatory drugs, vitamin supplements, or other antiplatelet drugs such as clopidogrel in the previous 30 days
Sites / Locations
- Stefania Basili
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Atorvastatin
Diet
Each day accordingly to randomization patients allocated to Atorvastatin received a pill of 40 mg of atorvastatin. In diabetic patients the concomitant aspirin treatment include a previous 30 days treatment with 100 mg daily of aspirin. All patients followed the diet used in the placebo group.
Low-fat diet with mean macronutrient profiles that were close to the present Adult Treatment Panel III guidelines (7% energy from saturated fat and, 200 mg dietary cholesterol per day)