Folic Acid Administration Reduces the Progression of Microalbuminuria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in albumin excretion rate
研究概览
简要总结
The development of diabetic nephropathy has been linked to several genetic polymorphisms, including those related with homocysteine metabolism such as the methylenetetrahydrofolate reductase (MTHFR)and the cystathionine-beta-synthase genes. Such alterations are associated with hyperhomocysteinemia, which is a known independent risk factor for the development of endothelial dysfunction and cardiovascular disease.
In the Mexican population there is a high prevalence of the C677T MTHFR mutation. The investigators performed this study to evaluate the prevalence of this polymorphism in type 2 diabetic patients with diabetic nephropathy compared with type 2 diabetic patients without nephropathy, besides evaluating the relationship of hyperhomocysteinemia with endothelial dysfunction and microalbuminuria before and after the administration of folic acid. We proposed that the endothelial dysfunction caused by the hyperhomocysteinemia could be reversed after the administration of folic acid.
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
- Single (Participant)
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 2 diabetes mellitus patients with 5 to 15 years of diagnosis
- •Microalbuminuria (defined as a urinary albumin/creatinine ratio between 30 and 300 mg/g)
- •A1c less than 9% in the last year
排除标准
- •Acute diabetic complications
- •A1c greater than 9% in the last year
- •Acute infectious process
- •Hepatic disease
- •Thyroid disease
研究组 & 干预措施
1
Administration of an oral placebo pill
干预措施: Placebo (Drug)
2
Administration of oral folic acid
干预措施: Folic acid (Drug)
结局指标
主要结局
Change in albumin excretion rate
时间窗: Four months
次要结局
- Change in serum homocysteine, thrombomodulin and von Willebrand factor.(Four months.)