Assessment of beneficial effects on left ventricular hypertrophy and diastolic function by metformin in hypertensive patients with type2 DM
- Conditions
- Hypertension, Type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000006504
- Lead Sponsor
- ational Hospital Organization Kyoto Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 440
Not provided
1) Patients with type 1 and 2 diabetes mellitus under insulin treatment or secondary diabetes patients 2) Patients with serious hepatic dysfunction/hepatic cirrhosis 3) Patients with unstable angina, acute myocardial infarction, severe coronary artery disease patients (Left Main Trunk or triple-vessel disease) 4) Patients with chronic atrial fibrillation or pacemaker patients 5) Patients with past lactic acidosis 6) Patients with severe dysfunction in cardiovascular system, pulmonary function disabled shock (such as heart failure, myocardial infarction, pulmonary embolism) and with easy to develop other hypoxemia 7) Heavy drinker 8) Patients with gastrointestinal disorder such as diarrhea and vomiting that worried dehydration 9) Patients with severe ketosis, diabetic coma orprecoma patients 10) Patients with severe infection, perioperative, severe injury 11) Those with malnutrition, starvation, debilitation, pituitary insufficiency or adrenal insufficiency patients 12) Those with allergic response for the object medicine 13) Pregnant and lactating patients or the patient who wishes to become pregnant 14) Those who judged inappropriate for the clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Left ventricular mass and diastolic function by echocardiography (LVMI, E/A, DT, E/e') 2) Blood biomarker of heart failure (BNP, NT-proBNP)
- Secondary Outcome Measures
Name Time Method 1) Left ventricular mass by cardiac MRI 2) Electrocardiogram (assessment of autonomic function by R-R variation) 3) Exploratory analysis To search a patient group in which metformin is useful by carrying out a stratified analysis of patient background male/female, extent and duration of diabetes mellitus, BMI, etc)