Links Between Diabetes and Cognitive Impairment in Myotonic Dystrophy Type 1 : a Non-conventional MRI Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Atrophy difference based on two cerebral MRI volumetries
研究概览
简要总结
The cognitive disorders of adult forms of myotonic dystrophies type 1 are heterogeneous (impairment of executive functions, visio construction and theory of the mind, which can progress to the stage of dementia). Nevertheless, patients have very different degrees of cognitive impairment. Expansion of CTG triplets disrupts the alternative splicing of mRNAs of various proteins, including the insulin receptor and Tau protein. Type 2 diabetes, associated with peripheral insulin resistance, is therefore common in this pathology.
Type 2 diabetes,could to explain the cognitive impairment of patients, through the accelerated development of brain lesions (especially tauopathy and cerebral atrophy).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Molecularly proven type 1 myotonic dystrophy
- •Voluntary, having given informed consent
- •Socially insured patient
- •Patient willing to comply with all study procedures and duration (3 hours + MRI 35 minutes)
- •Patient insured under the French social security system
- •Signed consent form
排除标准
- •Neurological history other than neuropathy: epilepsy, stroke, dementia
- •Pregnancy or breastfeeding or woman of childbearing age without effective contraception (a pregnancy test will be done)
- •Contra indication to MRI
- •Person under guardianship or curators
- •Persons of full age deprived of their liberties by a judicial or administrative decision
- •Major comorbidity considered as a contraindication by the investigator (cancer, unstable angina, etc.).
结局指标
主要结局
Atrophy difference based on two cerebral MRI volumetries
时间窗: at 4 years
difference between initial MRI and 4-year MRI
次要结局
- changes in scores at 4-year neuropsychological assessment of inclusion(At baseline at 4 years)
- changes in tau biomarkers in blood at 4 years of inclusion(At baseline at 4 years)
- changes in amyloid biomarkers in blood at 4 years of inclusion(At baseline at 4 years)