Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in dark adaptation kinetics and threshold values, amplitudes/implicit times, retinal vessel diameters, perfusion velocity and oximetry.
研究概览
简要总结
Retinal function is highly dependent on the glucose supply. Thus, functional adaptations occur in response to both acute and long-term changes in glycaemia.
The purpose of this study is to examine functional and metabolic aspects of retinal adaptation to long-lasting changes in glycaemic control in patients with diabetes. The adaptational phenomena will be characterized by electroretinography, dark adaptation, measures of retinal perfusion and oximetry as well as diabetic retinopathy grading and (OCT).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes and suboptimal metabolic regulation.
- •Patients with type 2 diabetes and suboptimal metabolic regulation.
排除标准
- •Significant cataract
- •Proliferative diabetic retinopathy fulfilling ETDRS treatment criteria.
- •Clinically significant macular edema fulfilling ETDRS treatment criteria.
- •Age-related macular degeneration
- •Prior surgery to the eye
- •Other serious eye disease
- •Hypertension
结局指标
主要结局
Changes in dark adaptation kinetics and threshold values, amplitudes/implicit times, retinal vessel diameters, perfusion velocity and oximetry.
时间窗: Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
Changes in visual acuity, diabetic retinopathy grading and OCT
时间窗: Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
次要结局
未报告次要终点
研究者
Oliver Niels Klefter
Principal Investigator
Glostrup University Hospital, Copenhagen