Corneal Confocal Microscopy in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Corneal small nerve fiber damage
研究概览
简要总结
Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes.
详细描述
Rationale: Poorly controlled diabetes mellitus is associated with microvascular complications, which includes peripheral neuropathy. Peripheral neuropathy associated with diabetes is a painful condition. Its diagnosis is hampered by painful and long nerve conduction studies which fail to diagnose small nerve neuropathy. It is important to study methods of noninvasive methods of early detection, which are sensitive and specific in diagnosing early neuropathy and we propose a novel study that this can be detected in the cornea of the eye.
Aims:
- Estimate corneal small nerve fiber damage in young T1DM subjects (corneal fiber density, nerve branch density, and fiber length) and compare the results to healthy controls using corneal confocal microscopy (CCM).
- Estimate corneal nerve fiber damage in subjects with diabetes, with peripheral neuropathy and subjects with diabetes without peripheral neuropathy, diagnosed by skin biopsies and nerve conduction studies
- Obtain much needed normative values for CCM in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes.
- As a secondary outcome measure, to compare serum biomarkers including leptin, TNF alpha, and fibrinogen in patients with diabetes in those with neuropathy Vs. without neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Type 1 Diabetes
Subjects with known Type 1 diabetes
干预措施: Nerve conduction study (Procedure)
Type 1 Diabetes
Subjects with known Type 1 diabetes
干预措施: Corneal confocal microscopy (Device)
Type 1 Diabetes
Subjects with known Type 1 diabetes
干预措施: Skin biopsy (Procedure)
Type 1 Diabetes
Subjects with known Type 1 diabetes
干预措施: Blood draw (Other)
Healthy Controls
Healthy controls
干预措施: Corneal confocal microscopy (Device)
Healthy Controls
Healthy controls
干预措施: Nerve conduction study (Procedure)
Healthy Controls
Healthy controls
干预措施: Blood draw (Other)
结局指标
主要结局
Corneal small nerve fiber damage
时间窗: Assessed one time per subject during study (study completed over 3 years)
Estimate corneal small nerve fiber damage in young T1DM subjects and compare the results to healthy controls using corneal confocal microscopy (CCM). This will be done by examining the cornea via confocal microscopy and obtaining images. These images will be evaluated looking at how many nerves there are, how they branch, and how long they are).
Normative values for corneal confocal microscopy (CCM)
时间窗: Assessed one time per subject during study (study completed over 3 years)
Obtain much needed normative values for CCM in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes. This will be done by obtaining a small biopsy of skin and looking at the number of nerve fibers in the outer layer of the skin.
次要结局
- Serum biomarkers - TNF Alpha(Assessed one time per subject during study (study completed over 3 years))
- Serum biomarkers - fibrinogen(Assessed one time per subject during study (study completed over 3 years))
- Serum biomarkers - leptin(Assessed one time per subject during study (study completed over 3 years))