NCT04547439招募中2 期
Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Sleep pattern
研究概览
简要总结
This study explores the use of melatonin in patients with diabetic retinopathy
详细描述
This is a randomized controlled study using melatonin for 8 weeks in patients with diabetic retinopathy on outcomes of sleep and circadian regulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants and investigators are blinded.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)
- •40-65 years of age
- •Diabetic retinopathy of at least moderate degree
排除标准
- •use of melatonin
- •antidepressants or antipsychotics
- •illicit drug use
- •night shift work or travel beyond 2 time zones in the month before enrollment
- •end stage renal disease requiring renal replacement therapy
- •history of stroke or transient ischemic attacks
- •history of dementia or memory impairment
- •uncontrolled congestive heart failure or recent hospitalization for cardiac condition (6 months)
- •chronic obstructive pulmonary disease requiring oxygen
- •severe chronic liver disease such as cirrhosis
- •ongoing treatment for major medical problems such as cancer
- •history of severe hypoglycemia defined as hypoglycemic episodes requiring assistance from others within the past six months.
- •Significant depressive symptoms
- •untreated severe OSA (AHI≥ 30 events/hour),
- •uncontrolled hypertension (blood pressure ≥ 160/100 mmHg),
- •uncontrolled diabetes (A1C ≥ 11%),
- •abnormal TSH
- •abnormal liver function (AST or ALT>3x upper limits of normal
- •use of sedatives and hypnotics.
- •clinically significant epiretinal membranes, clinically significant lens opacities, or cystoid macular edema, iris neovascularization, iris atrophy, or an asymmetrically shaped pupil, nuclear sclerotic, posterior subcapsular, or cortical lens opacities greater than 2+, a history of pan-retinal photocoagulation.
- •hemoglobin <11.5 g/dL in women and <13.5 g/dL in men.
研究组 & 干预措施
Control
Active Comparator
Placebo
干预措施: Placebo (Other)
Melatonin
Active Comparator
Melatonin
干预措施: Melatonin (Drug)
结局指标
主要结局
Sleep pattern
时间窗: 14 days
Sleep pattern: Sleep duration and sleep efficiency will be assessed by wrist actigraphy, to be worn by the participants for 14 days
Melatonin and Cortisol Rhythm
时间窗: 24 hours
Melatonin and cortisol pattern (peak times of the levels, dim light melatonin onset) will be assessed from 24 hour blood sampling
次要结局
未报告次要终点
研究者
Sirimon Reutrakul
Associate Professor
University of Illinois at Chicago
研究点 (2)
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