Tests melatonin in people with diabetic eye disease
Tests melatonin against placebo in adults with diabetic retinopathy, an eye complication.
Plain-language title generated from the registry record
Registry title: Sleep, Diabetic Retinopathy and Melatonin
Key facts
- Where
- Chicago, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 65 years old?
Source: NCT04547439, who can take part
Where in United States
- University of Illinois at ChicagoChicago, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Illinois Chicago
- Trial code
- NCT04547439
- Record updated
- 21 April 2026
- Original description
This study explores the use of melatonin in patients with diabetic retinopathyRead full original descriptionShow less
Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
This study explores the use of melatonin in patients with diabetic retinopathy
Inclusion: 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: 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; uncontrolled hypertension (blood pressure ≥ 160/100 mmHg),; uncontrolled diabetes (A1C ≥ 11%),; 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; abnormal liver function (AST or ALT>3x upper limits of normal; hemoglobin <11.5 g/dL in women and <13.5 g/dL in men; use of melatonin; antidepressants or antipsychotics; Significant depressive symptoms; untreated severe OSA (AHI≥ 30 events/hour),; abnormal TSH; use of sedatives and hypnotics.