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Melatonin may fix sleep in diabetic eye disease

NCT ID NCT04547439

Symptom relief Sponsor: University of Illinois at Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking 3 mg of melatonin each night for 8 weeks can improve sleep and daily body rhythms in people with diabetic retinopathy. Researchers will track sleep patterns and hormone levels in 42 adults aged 40-65 with type 2 diabetes and moderate eye damage. The goal is to see if this simple supplement can ease sleep problems linked to the condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melatonin
What this could lead to
If it works, this could point toward a simple, low-cost way to improve sleep and daily rhythms for people with diabetic retinopathy.
What could go wrong
This is a small, early-phase trial with only 42 participants. Melatonin may not improve sleep or eye health, and results may not apply to everyone with diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic retinopathy type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus Diabetic retinopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Illinois at Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

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