Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Progression of diabetic retinopathy, oscillary potential
研究概览
简要总结
This study evaluates the effect of melatonin 4 mg on circadian rhythm and visual function of patients with diabetes mellitus. Half of the patients will receive melatonin (arm-1) and the other half will receive placebo (arm-2), both groups in 3 weeks. After a week of washout, the patients will cross over to the other treatment arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Melatonin and placebo tablets are identicle in terms of taste, colour, tablet-size etc. The tablets are packed and masked by external manufacturer.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients
- •Age range 40-75 years
- •Participant should be legally competent
排除标准
- •Other known eye disease.
- •Eye disease manifestation during ocular examination.
- •Competing neurologic and systemic conditions affecting retina.
- •Use of any drugs influencing pupillary light reflex and sleep pattern.
- •Refractive error with need of > 6 diopter lenses.
- •Pregnancy
- •Alcohol consumption during the trial
- •Lack of cooperation
- •Allergy to melatonin and/or preservatives in melatonin and placebo
- •Reduced hepatic function
- •Fluvoxamin intake due to drug interaction
- •Consumption of Alpha-1 and beta-1 adnergic antagoists.
- •Alcohol consumption during treatment
研究组 & 干预措施
Arm 1
Melatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.
干预措施: Melatonin 4 mg Tablet (Drug)
Arm 2
Place, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.
干预措施: Melatonin 4 mg Tablet (Drug)
结局指标
主要结局
Progression of diabetic retinopathy, oscillary potential
时间窗: 3 weeks
Progression of diabetic retinopati measured with electroretinography
次要结局
- Post-illumination pupillary light response(3 weeks)
- Circadian photoentrainment(3 weeks)
- Retinal structure(3 weeks)
研究者
Shakoor Ba-Ali
Principal Investigator, Medical Doctor
Rigshospitalet, Denmark