Actively Recruiting

Phase 2
Age: 40Years - 65Years
All Genders
NCT04547439

Sleep, Diabetic Retinopathy and Melatonin

Led by University of Illinois at Chicago · Updated on 2026-04-21

42

Participants Needed

1

Research Sites

277 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Chicago

Lead Sponsor

U

University of Chicago

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Sleep, Diabetic Retinopathy and Melatonin

Who Can Participate

Age: 40Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically diagnosed type 2 diabetes, taking anti-diabetes medications or history of elevated A1C ≥6.5%
  • Age between 40 and 65 years
  • Diabetic retinopathy of at least moderate severity
Not Eligible

You will not qualify if you...

  • Current use of melatonin
  • Use of 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 within 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 with episodes requiring assistance within the past six months
  • Significant depressive symptoms
  • Untreated severe obstructive sleep apnea (AHI ≥ 30 events/hour)
  • Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg)
  • Uncontrolled diabetes (A1C ≥ 11%)
  • Abnormal thyroid stimulating hormone (TSH)
  • Abnormal liver function with AST or ALT >3 times upper limits of normal
  • Use of sedatives and hypnotics
  • Clinically significant epiretinal membranes, lens opacities, cystoid macular edema, iris neovascularization, iris atrophy, asymmetrically shaped pupil, nuclear sclerotic, posterior subcapsular, or cortical lens opacities greater than 2+
  • History of pan-retinal photocoagulation
  • Hemoglobin less than 11.5 g/dL in women and less than 13.5 g/dL in men

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

S

Sirimon Reutrakul

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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