Effects of EPA Alone and Combined With Vitamin E on Blood Leptin, Adiponectin and Enzymatic Antioxidants Levels in Type II Diabetic Patients; A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Changes in leptin and adiponectin after 12 Weeks
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of EPA(Eicosapentaenoic Acid)alone and with VitE in diabetic patients.
详细描述
Randomized, double-blind, placebo-controlled, parallel-group study design After a 12weeks, subjects with type II DM will be randomized to receive either 2000 mg pearl EPA per day plus a double-blinded matching placebo (1 corn oil pearls per day) for 12 weeks OR 400 mg VitE pearl plus double-blinded per day plus a double-blinded matching placebo (4 corn oil pearls per day) for 12 weeks OR 2000 mg pearl EPA per day plus a double-blinded matching 400 mg VitE pearl OR placebo(4corn oil pearls per day plus 1 corn oil pearls per day )for 12 weeks.The total dose of EPA pearl will be 2000 mg per day (with the EPA or matching placebo corn oil doses remaining at 4 pearls per day) and The total dose of VitE pearl will be 400 mg per day (with the VitE or matching placebo corn oil doses remaining at 1 pearls per day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DM Type II.
- •Antidiabetic drug therapy which cannot be stopped.
- •History of DM about 2-15 year.
- •Age between 30-55 year.
- •No History of circulatory, thyroid, pulmonary, liver, kidney, cancer.
排除标准
- •DM Type I.
- •Nephropathy.
- •Retinopathy.
- •Thyroid disease.
- •Renal failure.
- •pulmonary disease
- •Liver disease,
结局指标
主要结局
Changes in leptin and adiponectin after 12 Weeks
时间窗: 12 weeks
次要结局
未报告次要终点
