RecruitingPhase 2NCT04547439
Sleep, Diabetic Retinopathy and Melatonin
Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
Sponsor
University of Illinois at Chicago
Enrollment
42 participants
Start Date
Feb 3, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
This study explores the use of melatonin in patients with diabetic retinopathy
Eligibility
Min Age: 40 YearsMax Age: 65 Years
Inclusion Criteria3
- Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)
- -65 years of age
- Diabetic retinopathy of at least moderate degree
Exclusion Criteria21
- 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.
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Interventions
DRUGMelatonin
Melatonin 3 mg will be taken nightly for 8 weeks
OTHERPlacebo
Placebo will be given nightly for 8 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04547439
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