The Relationship of Advanced Glycation Endproducts in the Anterior Lens Capsule to Glycemic Status and Diabetic Retinopathy: A Cross Sectional Study of Patients With and Without Type 2 Diabetes Mellitus Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Change in Advanced Glycation Endproducts (AGE) Levels
研究概览
简要总结
The overall purpose of this COMIRB application is to perform a cross-sectional pilot study to aid in the design of a prospective epidemiologic study for an NIH grant application. The long term goal of this research is to determine if AGEs are predictors of glycemic control and the development of diabetic retinopathy in patients with T2DM. Understanding these relationships could lead to a prospective prediction of the onset/worsening of diabetic retinopathy in T2DM patients and in pre-diabetic individuals.
详细描述
Below are the specific aims and research hypotheses for the pilot study:
Specific Aim 1: To successfully recruit 80 subjects (40 with no diabetes, 20 with diabetes and no diabetic retinopathy and 20 with diabetes and diabetic retinopathy) and obtain adequate samples (blood and lens capsule) for further testing.
Hypothesis 1:
Recruitment of subjects with and without diabetes and diabetic retinopathy is feasible within our clinic and the process for collecting, processing and storing samples is adequate to support the full study.
Specific Aim 2: To measure anterior lens capsule AGEs and HbA1c levels in recruited patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older 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
结局指标
主要结局
Change in Advanced Glycation Endproducts (AGE) Levels
时间窗: 1 year
次要结局
- Change in HbA1C Levels(1 year)