Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Diabetes Mellitus, Glucose Intolerance
About this trial
This is an interventional prevention trial for Diabetes Mellitus focused on measuring Glucose intolerance, Diabetes mellitus, Statins,HMG-CoA
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria for the screening test (within 6 months before screening): LDL-cholesterol 100-159 mg/dl and/or total cholesterol 180-239 mg/dl At least one of the following: Fasting plasma glucose 100-125 mg/dl, and/or casual (non-fasting) plasma glucose 120-199 mg/dl, and/or HbA1c 5.5-6.0% At least two of the following risk factors for impaired glucose tolerance: Second degree relative with diabetes BMI >= 24 kg/m2 Systolic blood pressure >=130 mmHg, and/or diastolic blood pressure >= 85 mmHg, and/or receiving treatment for hypertension Triglyceride >= 150 mg/dl, and/or HDL < 40 mg/dl Written consent for participation in the study by their own volition after being provided sufficient explanation for the participation into this clinical trial Inclusion Criteria for the entry (Confirmed by screening test): -Impaired glucose tolerance by 75g oral glucose tolerance test (fasting plasma glucose <126 mg/dl and 2-h plasma glucose 140-199 mg/dl) Exclusion Criteria: History of diabetes (except gestational diabetes) Fasting plasma glucose >= 126 mg/dl , and/or 2-h plasma glucose >= 200 mg/dl HbA1c >= 6.5% Diabetic retinopathy Receiving with hormone replacement therapy Pancreatic diseases ( e.g. pancreatitis, pancreatectomy, pancreatic cancer), Endocrine diseases ( e.g. Cushing's syndrome, acromegaly, pheochromocytoma, aldosteronism, hyperthyroidism ) Receiving statins, fibrates or anion exchange resins Cancer or suspected cancer History of gastrectomy History of myocardial infarction, angina, or heart failure (NYHA Class >= III) Severe hypertension (SBP >= 180 mmHg or DBP >= 110 mmHg) Renal disease, including serum creatinine >= 2.0 mg/dl Hepatic disease, including transaminase (ALT or AST) >= 2 times the upper limit of normal Women hoping to become pregnant during the intended study period Contraindication or relative contraindication of Livalo® Tab(pitavastatin calcium) History of hypersensitivity to any of the ingredients of the product Severe hepatic disorder or biliary atresia Receiving cyclosporine Pregnant women, women suspected of being pregnant, or lactating women Patients receiving fibrates who also have laboratory evidence of abnormal renal function Familial hypercholesterolemia Drug abuse, alcoholism Individuals who are ineligible in the opinion of the investigator
Sites / Locations
- The University of Tokyo, Graduate School of Medicine
Arms of the Study
Arm 1
Other
Pitavastatin
Administration of Pitavastatin