THE USE OF ASPIRIN AS PRIMARY PREVENTION IN PATIENTS WITH DIABETES

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 180

Inclusion Criteria

Inclusion criteria CASES:
1. Patients of both sexes aged between 18 and 40.
2. Outpatients visited regularly in our outpatient center or reference area of the Diabetes Unit of Endocrinology and Nutrition Territorial Girona (UDENTG) diagnosed with type 1/2 diabetes for at least 1 year of evolution.
3.patients with diabetes mellitus (as type 1 and type 2) who meet the criteria for metabolic syndrome defined as:
- Central obesity (BMI> 30kg/m2) HIGH-LIMIT <39.9 kg/m2
- Waist circumference (in Europe): Men> or => 94 cm and women> or => 80 cm
- More than two of any of the following factors:
o Increased triglycerides:> 150 mg / dl or specific treatment for this lipid abnormality.
or decrease in HDL-C <40 mg / dl (men) or <50mg/dL (women) or specific treatment for this lipid abnormality.
o Increased systolic blood pressure> 130 mmHg or diastolic> 85 mm Hg or specific treatment of previously diagnosed hypertension.
o Increased blood glucose:
? fasting blood glucose> 100 mg / dl or
? previously diagnosed type 2 diabetes.
4. Affects type 1/2 patients who met diagnostic criteria for NO metabolic syndrome (as defined in paragraph 3) diabetes.
5. Signed informed consent priot to participation in the study.

- Inclusion criteria CONTROLS:
1. Patients of both sexes aged between 18 and 40.
2. Outpatients visited regularly in our outpatient center or reference area of the Diabetes Unit of Endocrinology and Nutrition Territorial Girona (UDENTG) fulfilling diagnostic criteria for metabolic syndrome that are NOT diabetic.
3. Volunteers Healthy individuals without a diagnosis of diabetes or who meet diagnostic criteria for metabolic syndrome.
4. Signed informed consent prior to participation in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of previous cardiovascular disease, uncontrolled hypertension, ischemic or hemorrhagic gastrointestinal disease and asthma stroke.
2. Severe systemic disease unrelated to diabetes and cancer, severe liver or renal disease.
3. Previous use of chronic treatment with aspirin or any other antiplatelet drug (in the two weeks prior to baseline).
4. Hematologic or coagulation Pathology.
5. Hypersensitivity to aspirin.
6. Treatment that could interact with AAS as acetazolamide, anticoagulants, antineoplastic agents, alcohol, antacids, corticosteroids, other NSAIDs, methotrexate, niacin, anticonvulsants, and antidepressants alendròmic acid.
7. Recent vaccination (less than 2 months).
8. Pregnancy and lactation.
9. Persons released on legal or administrative requirement.
10. Symptoms and clinical signs of infection in the month prior to recruitment.
11. History of major psychiatric at the discretion of the investigator

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary endpoint of our study is the degree of antiplatelet therapy in different population groups.;Timepoint(s) of evaluation of this end point: at day 0 and 7;Main Objective: Compare platelet reactivity in different subgroups of diabetic population without prior vascular disease (such as diabetes 1 and type 2 diabetics) with and without metabolic syndrome criteria on what happens in the general healthy population.;Secondary Objective: 1. Define the phenotypic characteristics of individuals according to their platelet reactivity <br>2.Compare the effectiveness of different treatment regimens with aspirin in these subgroups of patients versus the general healthy population.<br>3. Assess endothelial dysfunction <br>4. Assess the status/level of inflammation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Demographyc and clinical data<br>Medical history<br>cormobidities<br>Concomitant medication<br>Complete physical examination<br>Blood sample;Timepoint(s) of evaluation of this end point: Last day of study