Hypertension, Type 2 diabetes mellitus
Conditions
Interventions
Oral diabetic agents except metformin, and pioglitazone
Metgluco (drug code) 500-1, 500mg/day p.o.
Sponsors
National Hospital Organization Kyoto Medical Center
Graduate School of Medicine, Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 30=<age<75 years old (male and female) 2) Patients with hypertension (blood pressure is less than 140/90mmHg and stable for at least 1 month. The subjects include patients who receive antihypertensive medication. LVEF>=50%) 3) Type 2 diabetes mellitus patients with HbA1c>=6.5%. These exclude patients who receive medication with metformin and pioglitazone for 3 months before enrollment. These also exclude patients who receive insulin therapy for 1 year before enrollment. 4) Patients without renal dysfunction (Serum creatinine: <1.3mg/dL (male), <1.2 mg/dL (female)) 5) Patients with informed consent of taking part in clinical research
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactKoji Hasegawa
National Hospital Organization Kyoto Medical Center Division of Translational Research
Outcome results
None listed