Regulation of Brain Glucose Metabolism in Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Cognitive Function
研究概览
简要总结
This is a prospective randomized placebo-controlled double-blind crossover pilot study determining the effect of dichloroacetate on brain function under clamped hypoglycemia in T1DM.
详细描述
This study is a prospective randomized placebo-controlled double-blind crossover study designed to address the hypothesis that dichloroacetate has the ability to re-activate brain glucose metabolism under clamped hypoglycemia. The study population is comprised of intensively treated persons with T1D with frequent exposure to hypoglycemia, who have cognitive deficits under hypoglycemia that could be attributed to changes in brain glucose oxidation. The investigators will test the experimental compound DCA in a study that determines whether restoring brain glucose metabolism under hypoglycemia helps maintain cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1DM subjects with:
- •a history of severe hypoglycemia and/or hypoglycemia unawareness or
- •a history of severe hypoglycemia with a blood glucose <54 mg/dL, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or
- •at least 2 values <54mg/dl during 2 weeks of CGMS testing during the week prior to study.
排除标准
- •Age < 18 years or >55 years.
- •Body weight >85 kg at screening visit
- •BMI > 30 (female) and >30 (male) kg/m
- •Untreated proliferative retinopathy
- •carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose to DCA accumulation and toxicity
研究组 & 干预措施
Placebo
oral solution with flavoring agent, no active drug.
干预措施: Dichloroacetate (Drug)
Dichloroacetate
oral solution of dichloroacetate with flavoring agent
干预措施: Dichloroacetate (Drug)
结局指标
主要结局
Cognitive Function
时间窗: 1 day
Measures of reaction time \[in milliseconds\] and cognitive testing performance under hypoglycemia \[percentage\].
次要结局
- Brain glucose metabolism(1 day)
研究者
Raimund Herzog
Associate Professor of Medicine
Yale University