Metformin in diastolic dysfunction of metabolic syndrome

• Conditions: Diastolic dysfunction in non-diabetic patients with metabolic syndrome; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002269-21-PT
• Lead Sponsor: Department of Physiology and Cardiothoracic Surgery, Faculty of Medicine, University of Porto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-18
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 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)]
AND WITH
- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified