NCT01130727已完成不适用
Randomized Clinical Trial, Placebo Controlled, With Parallel Groups to Investigate Whether Green Tea or Cocoa Extracts Improves Endothelial Dysfunction in Patients With Diabetes Mellitus and Nephropathy and Hypertension
University of Campinas, Brazil2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2010年5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
- 51
- 试验地点
- 2
- 主要终点
- flow-mediated dilation (FMD)
研究概览
简要总结
The purpose of this study is to determine whether green tea or cocoa extracts are effective in improve endothelial dysfunction in patients with diabetes mellitus and nephropathy and arterial hypertension.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or type 2 diabetes mellitus
- •Diabetic nephropathy
- •Hypertension
排除标准
- •GFR < 30 ml/min/1.73m2
- •Serum K > 5.5 mEq/L
- •Age < 18 y
- •Pregnancy
- •Breast feeding
- •Cocoa or green tea intolerance
- •Alcohol and drugs abuse
- •Incapacity to understand the information related to the study
结局指标
主要结局
flow-mediated dilation (FMD)
时间窗: up to 4 hours
次要结局
- arterial blood pressure and cardiac rate(up to 4 hours)
- plasma levels of flavonols(up to 4 hours)
研究者
Jose Butori Lopes de Faria
Professor
University of Campinas, Brazil
研究点 (2)
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