Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- The utility of corneal confocal microscopy to assess diabetic neuropathy in children.
研究概览
简要总结
The overall aim of this study is to confirm the utility of corneal confocal microscopy (CCM) as a new technique to rapidly and non-invasively assess diabetic neuropathy (DN) in children. This study will be divided into two phases: Phase 1 will be a cross-sectional study of children with type 1 diabetes and normal controls, while phase 2 will be a longitudinal assessment of a subgroup of children with type 1 diabetes recruited during Phase 1.
详细描述
In phase 1: To compare corneal nerve density (CND), length (CNL), and branching (CBD) by CCM between
- children with type 1 diabetes for 5 years or more to children without diabetes;
- children with type 1 diabetes with and without evidence of diabetic neuropathy;
- to examine the relationship between CND, CNL & CBD and known risk factors of diabetic neuropathy
In phase 2:
- to examine for changes in corneal nerve morphology two years after the initial CCM exam.
- to describe the evolution of diabetic neuropathy based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction.
- to assess if changes in corneal nerve morphology correlate with changes in nerve conduction velocity and autonomic testing.
- To examine the risk factors associated with progression of diabetic neuropathy in our pediatric population.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CASES: Children with Type 1 Diabetes 8 to 18 years old followed at the Alberta Children's Hospital Diabetes Clinic with a duration of diabetes of at least 5 years.
- •CONTROLS: Healthy children aged 8 to 18 years.
排除标准
- •Patients with known history of corneal abnormality, trauma, or surgery
- •Any other cause of neuropathy
- •Individuals with uncontrolled hypothyroidism
- •Individuals with celiac disease
- •Other serious chronic illnesses besides diabetes
- •Inability to cooperate with testing
- •Families unwilling to provide written informed consent
结局指标
主要结局
The utility of corneal confocal microscopy to assess diabetic neuropathy in children.
时间窗: 2 years
To confirm the utility of corneal confocal microscopy (CCM) as a new technique to rapidly assess diabetic neuropathy (DN) in children. This non-invasive eye imaging method may be a superior alternative to traditional nerve conduction studies. This study will be divided into two phases: Phase 1 will be a cross-sectional study of children with Type 1 Diabetes (T1D) and normal controls, while phase 2 will be a longitudinal assessment of a subgroup of T1D children recruited during Phase 1.
次要结局
- Corneal nerve density (CND) by CCM(Single time point)
- Corneal nerve length (CNL) by CCM.(Single time point)
- Corneal nerve branching density (CBD) by CCM(Single time point)
- Changes in corneal nerve morphology two years after the initial CCM exam.(2 years)
研究者
Dr. Danièle Pacaud
Associate Professor
University of Calgary