Phase 3 Study of Cranberry on Lipid Profiles in Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- the change of total to HDL cholesterol ratio
研究概览
简要总结
Cranberry, containing flavonoids, is effective on improvement of lipid profiles in non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid profiles in type 2 diabetic patients using oral antidiabetic drugs.
详细描述
Hypercholesterolemia is a notorious risk factor for cardiovascular disease. It had been reported cranberry consumption increased nearly 8% of circulating high-density lipoprotein (HDL) cholesterol levels in non-diabetic subjects. Although characteristics of diabetic dyslipidemia are low HDL and high triglyceride, the benefits of concentrated powder of cranberry juice on lipid profiles were not evident in type 2 diabetic subjects with diet control alone. To the best of our knowledge, the effect of cranberry on lipid profiles in type 2 diabetic subjects using oral anti-diabetic drugs have never been studied, especially total to HDL cholesterol ratio which is important in predicting cardiovascular diseases in Asian and/or diabetic population. Furthermore, cranberry has anti-oxidative effect which is associated with reduction of oxidized low-density lipoprotein (ox-LDL) cholesterol in non-diabetes. Therefore, we conducted a placebo-controlled, double-blind, randomized study to assess the effect of cranberry on lipid profiles in type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetic subjects
- •age between 50 and 75 years
排除标准
- •glycosylated hemoglobin (HbA1c) less than 7% or more than 10%;
- •triglyceride more than 4.5 mmol/L;
- •current insulin treatment;
- •change of the medications for anti-diabetes, hypertension, hyperlipidemia and anti-platelet in recent four weeks;
- •abnormal renal function (serum creatinine > 177 μmol/L;
- •abnormal liver function test results (more than two-fold upper limit of normal range);
- •severe systemic disease such as immune disorder, cancer, acute or chronic inflammation disease;
- •smoking in recent 1 year;
- •alcoholism (more than two drinks daily);
- •using steroid or drugs with unknown components;
- •pregnancy or breast-feeding.
结局指标
主要结局
the change of total to HDL cholesterol ratio
时间窗: 12 weeks
次要结局
- the change of ox-LDL(12 weeks)
- the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride)(12 weeks)
- the change of fasting plasma glucose(12 weeks)
- the change of HbA1c(12 weeks)
- the change of CRP(12 weeks)
- the change of UAE(12 weeks)