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临床试验/NCT00817622
NCT00817622已完成4 期

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

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2007年1月最近更新:
适应症

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

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

研究者

申办方类型
Other

研究点 (1)

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