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Sleep, Diabetic Retinopathy and Melatonin

RecruitingPhase 2

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

Who can join

Ages 40 to 65 · All sexes

Full eligibility criteria
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.

About the study

This study explores the use of melatonin in patients with diabetic retinopathy

What is being tested

Sponsor: University of Illinois at Chicago · Participants: 42 · Started: Feb 3, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04547439

Locations in the U.S.

IllinoisUniversity of Illinois at Chicago, Chicago

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.