NCT00301392已完成4 期
Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Tokyo University1 个研究点 分布在 1 个国家目标入组 1,240 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,240
- 试验地点
- 1
- 主要终点
- Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels
研究概览
简要总结
The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes in a population with impaired glucose tolerance.
详细描述
Diabetes mellitus and its complications are major health problems globally. People with impaired glucose tolerance (IGT) are at high risk of developing diabetes. It is therefore important to focus on preventing diabetes in individuals with IGT. HMG-CoA reductase inhibitors (statins) are widely used for hypercholesterolemia, one of the most frequent metabolic disorders. However, there is no direct evidence to whether statins are beneficial for preventing diabetes. This study is designed to compare the efficacy of life-style modification versus life-style modification with pitavastatin (a statin) administration, in individuals with IGT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Pitavastatin
Other
Administration of Pitavastatin
干预措施: Life style interventions plus concomitant use of pitavastatin. (Drug)
Pitavastatin
Other
Administration of Pitavastatin
干预措施: life-style intervention (Other)
结局指标
主要结局
Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels
时间窗: from April, 2006 to end of March, 2012
次要结局
- Incidence of newly developed diabetes(from April, 2006 to end of March, 2012)
- Cumulative incidence of diabetes based on clinical diagnosis.(from April, 2006 to end of March, 2012)
- Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels(from April, 2006 to end of March, 2012)
- Time until development of diabetes; Improvement in glucose tolerance(from April, 2006 to end of March, 2012)
- Incidence of any cardiovascular disease (myocardial infarction, angina, congestive heart disease, coronary revascularization, cerebral hemorrhage, cerebral infarction.(from April, 2006 to end of March, 2012)
- Incidence of coronary heart disease (myocardial infarction, angina, coronary revascularization)(from April, 2006 to end of March, 2012)
- LDL-cholesterol(from April, 2006 to end of March, 2012)
- HDL-cholesterol(from April, 2006 to end of March, 2012)
- Triglyceride(from April, 2006 to end of March, 2012)
- RLP-cholesterol(from April, 2006 to end of March, 2012)
- Adiponectin(from April, 2006 to end of March, 2012)
- High sensitive CRP(from April, 2006 to end of March, 2012)
- Asymmetrical dimethyl arginine (ADMA)(from April, 2006 to end of March, 2012)
- Urinary 8-OHd(from April, 2006 to end of March, 2012)
- Fasting plasma glucose(from April, 2006 to end of March, 2012)
- Incidence of coronary heart disease plus cerebral infarction(from April, 2006 to end of March, 2012)
- 2-h plasma glucose during 75g oral glucose tolerance test(from April, 2006 to end of March, 2012)
- HbA1c(from April, 2006 to end of March, 2012)
- Insulin(from April, 2006 to end of March, 2012)
- HOMA-R(from April, 2006 to end of March, 2012)
- HOMA-β(from April, 2006 to end of March, 2012)
- Insulinogenic index(from April, 2006 to end of March, 2012)
- Time until dropout(from April, 2006 to end of March, 2012)
- Number of adverse events(from April, 2006 to end of March, 2012)
研究者
Tsutomu Yamazaki
Professor
Tokyo University
研究点 (1)
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