NCT00363233已完成2 期
The Effects of Flax Lignans on Lipid Profile and Glucose Management in Type 2 Diabetes: a Randomized Double-Blind Cross-Over Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total cholesterol at 3 months
研究概览
简要总结
The purpose of the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients.
详细描述
The prevalence of type 2 diabetes is increasing dramatically in the last decade in China. Hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health outcomes. Flax lignans, a phytoestrogen found in flaxseed is thought to be the compound responsible for cholesterol-lowering effect of flaxseed. Our purpose is to improving the lipid profile in type 2 diabetic patients with supplementation of flax lignans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed type 2 diabetes
- •Age: 50-79 years old
- •LDL-cholesterol more than 2.9 mmol/l
排除标准
- •Current or previous (within 6 months) use of estrogen therapy
- •Chronic gastrointestinal diseases
- •Current use of antibiotics
- •Any severe liver or renal diseases
- •Systolic blood pressure more than 180 mmHg or phase 3 hypertension
- •Any severe mental diseases
- •Severe cardio- or cerebro-vascular diseases
结局指标
主要结局
Total cholesterol at 3 months
次要结局
- LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months
研究者
研究点 (1)
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