NCT02111967已完成不适用
Adequacy of Serum Vitamin B12 Measurement in Type 2 Diabetic Patients Treated With Metformin in Comparison to Holotranscobalamin Measurement
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measurements of serum vitamin B12 and serum holotranscobalamin concentrations
研究概览
简要总结
In this study we compare the vitamin B12 status by measuring serum vitamin B12 and holotranscobalamin in type 2 diabetic patients with and without metformin treatment. Afterwars we investigate which biomarker could be adequate to reflect B12 status in metformin-treated patients.
With the help of a questionnaire we assess clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Diagnosis of T2DM > 6 months
- •Metformin treatment for at least 6 months
- •Age > 18 years
- •Ability to give written informed consent
- •No metformin treatment in the last 6 months (control group)
排除标准
- •Concurrent intake of preparations containing VB12 (within the last 3 months prior to study participation)
- •Lack of written and/or oral understanding in German, French, Italian or English languages
- •Diagnosis of Transcobolamin transporter defect
- •Diagnosis of Chronic or acute liver diseaseliver insufficiency with CHILD-PUGH scores B and C and acute hepatitis
- •Diagnosis of Renal disease (Creatinine-Clearance <60 ml/min)renal insufficiency stadium III, IV and V (KDOQI) and acute renal diseases
结局指标
主要结局
Measurements of serum vitamin B12 and serum holotranscobalamin concentrations
时间窗: day 3
VB12, HoloTc
次要结局
- Questionnaire results(day 8)
研究者
Philipp Walter, PhD
Dr.
University of Basel
研究点 (1)
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