Sleep, Diabetic Retinopathy and Melatonin

Study Overview
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Brief Summary
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This study explores the use of melatonin in patients with diabetic retinopathy

Detailed Description
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This is a randomized controlled study using melatonin for 8 weeks in patients with diabetic retinopathy on outcomes of sleep and circadian regulation

Official Title
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Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation

Conditions
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Diabetes Mellitus, Diabetic Retinopathy

Intervention / Treatment
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* Drug: Melatonin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded randomized controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Placebo | Other: Placebo<br>* Placebo will be given nightly for 8 weeks<br>|
| Active Comparator: Melatonin<br>Melatonin | Drug: Melatonin<br>* Melatonin 3 mg will be taken nightly for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep pattern | Sleep pattern: Sleep duration and sleep efficiency will be assessed by wrist actigraphy, to be worn by the participants for 14 days | 14 days | 
| Melatonin and Cortisol Rhythm | Melatonin and cortisol pattern (peak times of the levels, dim light melatonin onset) will be assessed from 24 hour blood sampling | 24 hours |