Metformin in diastolic dysfunction of metabolic syndrome - MET-DIME Trial

Department of Physiology and Cardiothoracic Surgery, Faculty of Medicine, University of Porto0 个研究点开始时间: 2013年6月18日最近更新: 2014年1月27日

试验速览

暂无简介。

•- Non-diabetic adults aged between 40 and 64 years fulfilling the AHA/NHLBI criteria for clinical diagnosis of metabolic syndrome [(at least 3 of the following: waist circumference =102cm in males or =88cm in females; fasting plasma triglycerides =150mg/dL or on drug treatment for elevated triglycerides; fasting HDL cholesterol ?40mg/dL in males or ?50mg/dL in females or on drug treatment for reduced HDL; systolic blood pressure=130mmHg or diastolic blood pressure=85mmHg or on antihypertensive drug treatment in a patient with history of hypertension; fasting plasma glucose=100mg/dL)]
•- Echocardiographic evidence of left ventricle diastolic dysfunction at rest, considering the mean of septal and lateral E’ as assessed by Tissue Doppler Imaging echocardiography (E’mean?10.2 cm/s if 40-59 years old or E’mean?7,2 cm/s if aged 60 to 65 years old).
•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 54
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Diagnosis of diabetes mellitus according to the ADA criteria (at least one of the following: fasting plasma glucose =126mg/dL; 2-hour plasma glucose =200mg/dL during an oral glucose tolerance test, as described the WHO; random plasma glucose =200mg/dL in a patient with classical symptoms of hyperglycemia or hyperglycemic crisis; hemoglobin A1C=6.5% using a method that is NGSP certified and standardized to the DCCT assay or =48mmol/mol reported in IFCC units)
•- Previous diagnosis of ischemic heart disease (history of angina, acute coronary syndrome, acute myocardial infarction or coronary artery bypass graft surgery);
•- Left ventricle ejection fraction less than 50% (assessed by transthoracic echocardiography);
•- Moderate or severe cardiac valvular disease;
•- Pericardial disease;
•- Uncontrolled atrial or ventricular tachyarrhythmias;
•- History of myocarditis;
•- Renal disease or dysfunction (plasma creatinine =1.5mg/dL in males or =1.4mg/dL in females);
•- Significant liver disease (aspartate aminotransferase or alanine aminotransferase =2.5 times upper limit of normal);
•- Females who are pregnant, planning to become pregnant or who admit sexual activity without appropriate contraception;
•- Lactation.
•- Unable to perform cardopulmonary exercise test.
•- Recent (less than 1 month) change in anti-hypertensive or antidislipidemic medications.

发起方

Department of Physiology and Cardiothoracic Surgery, Faculty of Medicine, University of Porto