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临床试验/NCT01895387
NCT01895387已完成不适用

Replacing With Whole Grains and Legumes Reduces Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activities in Plasma and Peripheral Blood Mononuclear Cells in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes

Yonsei University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Plasma Lp-PLA2 activity

研究概览

简要总结

We determined the effects of dietary intervention (replacement of refined rice with whole grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.

详细描述

Ninety-nine patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes were randomly assigned to either a control group (usual diet with refined rice) or the whole grain group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
39 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose <126 mg/dL)
  • •or newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL)

排除标准

  • •current and/or past history of cardiovascular disease including angina
  • •liver or kidney dysfunction
  • •thyroid or pituitary disease
  • •unstable weight loss/gain (≥2 kg) over the previous 12 months
  • •pregnancy or lactation
  • •taking medications or supplements

研究组 & 干预措施

Whole grains and legumes

Experimental

干预措施: Dietary intervention-whole grains and legumes (Dietary Supplement)

Refined rice

Placebo Comparator

干预措施: Dietary intervention-Refined rice (Dietary Supplement)

结局指标

主要结局

Plasma Lp-PLA2 activity

时间窗: Change from baseline in Lp-PLA2 at 12 weeks

次要结局

  • PBMC Lp-PLA2 activity(Change from baseline in PBMC Lp-PLA2 at 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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