Recruiting
Phase 2

Melatonin

Sponsor:

University of Illinois at Chicago

Code:

NCT04547439

Conditions

Diabetes Mellitus

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Not accepted

Interventions

Melatonin

Placebo

Study Details

Brief summary:

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

Conditions

Diabetes Mellitus

Diabetic Retinopathy

Study ID

NCT04547439

Start date

Feb 3, 2021

Status verified date

Apr, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Feb 2, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Control

Placebo

active comparator: Melatonin

Melatonin

Interventions

Melatonin

Melatonin 3 mg will be taken nightly for 8 weeks

Placebo

Placebo will be given nightly for 8 weeks

Primary outcome measure

  • Sleep pattern [ Time Frame: 14 days ]
  • Melatonin and Cortisol Rhythm [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Sirimon Reutrakul

3129966060sreutrak@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-04-21.