NCT01025115已完成3 期
Efficacy of Diamel in the Treatment of Metabolic Syndrome
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Blood concentrations of glucose at months 0,3,6,9,12.
研究概览
简要总结
The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metabolic syndrome diagnosis according to WHO definition, with or without glucose intolerance.
- •Signed informed consent
排除标准
- •Type 1 diabetes
- •Type 2 diabetes treated with oral hypoglycemic drugs and/or insulin
- •Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
- •Neuropathies or hepatic conditions diagnosed biochemically or by clinical exam.
- •Mild or severe heart conditions (eg. heart failure, ischemic cardiopathy)
- •Sepsis or any other condition that could potentially interfere with treatment
- •Any other treatment that could potentially interfere with treatment
- •Pregnancy
结局指标
主要结局
Blood concentrations of glucose at months 0,3,6,9,12.
时间窗: 12 months
Blood concentrations of insulin at months 0,3,6,9,12.
时间窗: 12 months
Blood concentrations of cholesterol at months 0,3,6,9,12.
时间窗: 12 months
Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.
时间窗: 12 months
Blood concentrations of triglycerides at months 0,3,6,9,12.
时间窗: 12 months
Blood concentrations of creatinine at months 0,3,6,9,12.
时间窗: 12 months
Blood concentrations of uric acid at months 0,3,6,9,12.
时间窗: 12 months
次要结局
- Blood pressure at months 0,3,6,9,12.(12 months)
- BMI index at months 0,3,6,9,12.(12 months)
- Waist-to-hip index at months 0,3,6,9,12.(12 months)
研究者
研究点 (2)
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