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Melatonin for Sleep and Diabetic Retinopathy

This study is looking at whether taking melatonin can help people with type 2 diabetes and diabetic retinopathy (damage to the blood vessels in the retina, the light-sensitive tissue at the back of the eye). We want to see if melatonin affects sleep patterns and the body's natural rhythms of melatonin and cortisol (a stress hormone). You could join if you are 40-65 years old, have type 2 diabetes, and at least moderate diabetic retinopathy. You cannot join if you already use melatonin, take certain medications, or work night shifts. The study plans to enroll 42 participants. The current status of the study is unclear.

Study design
This is a randomized controlled study, meaning participants will be randomly assigned to receive either melatonin or a placebo (an inactive substance). The study plans to enroll 42 participants.
What's involved
You would take either melatonin 3 mg or a placebo nightly for 8 weeks. Sleep patterns will be measured at 14 days, and melatonin and cortisol rhythms will be measured at 24 hours.
Compensation
Not stated in the trial record.
Follow-up
Sleep patterns are measured at 14 days, and melatonin and cortisol rhythms are measured at 24 hours.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04547439

Sleep, Diabetic Retinopathy and Melatonin

Recruiting
PHASE2Ages 40–65Interventional
University of Illinois at Chicago
~42 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:MelatoninPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sleep pattern
Measured over 14 days
+1 more outcome measured

Conditions

Diabetes Mellitus
Diabetic Retinopathy

Explore related trials

Diabetes MellitusDiabetic Retinopathy

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Sirimon Reutrakul
[email protected]
3129966060
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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.

What this trial measures

  • Sleep pattern14 days

    Sleep pattern: Sleep duration and sleep efficiency will be assessed by wrist actigraphy, to be worn by the participants for 14 days

  • Melatonin and Cortisol Rhythm24 hours

    Melatonin and cortisol pattern (peak times of the levels, dim light melatonin onset) will be assessed from 24 hour blood sampling