NCT01802541已完成不适用
Effect of Diacylglycerol Oil on Risk Factors of Type 2 Diabetes and Complicating Disease, and Mechanism
Zhejiang University0 个研究点目标入组 127 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 主要终点
- insulin resistance
研究概览
简要总结
Diacylglycerol oil has been shown to lower postprandial and fasting serum triacylglycerol levels and reduce body fat. The investigators hypothesize that replacing dietary fat with diacylglycerol oil reduces excess body fat in type 2 diabetic patients and that diacylglycerol oil has a beneficial effect on cardiovascular risk factors in Chinese type 2 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients, blood sugar levels were stabilized between 7.0-10.0 mmol/L
- •Male, aged 40 - 70 years old, Female, aged post-menopausal - 70 years old.
- •Overweight/obese patients (BMI 25 - 40 kg/m2)
- •Currently under diet therapy for diabetes mellitus
- •Understands the procedures and willing to participate in the study
排除标准
- •Patients who unwilling to give informed consent
- •Type 1 diabetic patients
- •Familial hyperlipemia patients or blood triacylglycerol concentration > 400 mg/dl
- •Patients with a history of cardiovascular disease and/or arteriosclerotic disease
- •Patients with a history of cerebrovascular disease
- •Patients with serious hepatic disease and/or renal disease
- •Patients with malignancy
- •Participation in another clinical study within 30 days prior to screening period.
- •Has a condition the doctor in charge believes would interfere with evaluation of the subject, or may put subject at undue risk
结局指标
主要结局
insulin resistance
时间窗: 120 days
次要结局
未报告次要终点
研究者
Duo li
Professor
Zhejiang University
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