Can Oral Benfotiamine Supplementation Influence Progression of Microvascular Complications in Patients With Type 1 Diabetes?
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Lower-limb nerve conduction velocity
研究概览
简要总结
The purpose of this study is to determine whether benfotiamine supplementation can reduce markers of microvascular complications in type 1 diabetic patients.
详细描述
Despite intensive strategies designed to achieve good metabolic control, diabetic patients are still at a markedly increased risk of eye and kidney disease, nerve damage, limb amputation, stroke and myocardial infarction as a result of long-term hyperglycemia. It has recently been shown that supplementation with lipid soluble vitamin B1 (benfotiamine) in diabetic rats could effectively block three major biochemical pathways of hyperglycemic damage. It has also been shown that supplementation prevented the development of experimental diabetic retinopathy and nephropathy, without changes in glycemic control. However, the applicability of the above findings to humans is unknown, and the diabetic late complications in experimental animals do not in every aspect mirror the human diabetic complications.
This project will allow us to evaluate the potential of benfotiamine to reduce or prevent the further development of microvascular disease in type 1 diabetics.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes (of at least 15 years duration) as assessed by medical history.
排除标准
- •Macroalbuminuria
- •Symptomatic gastroparesis. Diabetic nephropathy with a creatinine clearance less than 60 cc/min.
- •Evidence of chronic infection.
- •History of any malignancy.
- •Any chronic medical condition that unduly increases the risk for the potential enrollee as judged by study investigators.
- •Pregnancy, breastfeeding or planned pregnancy within two years.
- •Supplementation with thiamine > 2mg per day and/or alpha-lipoic acid
- •Chronic alcoholism/alcohol abuse.
研究组 & 干预措施
Placebo
Placebo for benfotiamine
干预措施: Placebo (Drug)
Benfotiamine
Benfotiamine 300mg/day
干预措施: Benfotiamine (Drug)
结局指标
主要结局
Lower-limb nerve conduction velocity
时间窗: 24 months
次要结局
- Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1)(24 months)
研究者
Kristian F. Hanssen
Professor
Oslo University Hospital