EUCTR2014-003064-21-ES进行中（未招募）1 期
THE USE OF ASPIRIN AS PRIMARY PREVENTION IN PATIENTS WITH DIABETES - ASPIRIN PROTOCO
Hospital Universitari de Girona Dr. Josep Trueta0 个研究点目标入组 180 人开始时间: 2014年9月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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