NCT02588898已完成不适用
B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Red blood cell cobalamin levels
研究概览
简要总结
This case-control study investigated B-vitamin and homocysteine in relation to the presence or the absence of type 2 diabetes and clinical signs of polyneuropathy.
详细描述
Blood samples were collected and clinical investigations were performed at the same time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects with or without diabetes.
排除标准
- •Usage of supplements containing B-vitamins, methotrexate treatment, cerebral or cardiac events in the last three months
- •Liver or renal dysfunction.
结局指标
主要结局
Red blood cell cobalamin levels
时间窗: Baseline
Polyneuropathy grade estimated using a score including a combination of data from questionnaire and electrophysiology investigations
时间窗: Baseline
Polyneuropathy grade was accessed using a questionnaire and a clinical examination (electrophysiology) after nerve stimulation. A score includes the combination of questionnaire data and electrophysiology data.
次要结局
- Plasma choline levels(Baseline)
- Plasma methylmalonic acid levels(Baseline)
- Plasma cobalamin levels(Baseline)
研究者
Rima Obeid
Prof. (apl.) Dr.
Universität des Saarlandes
研究点 (1)
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