Sleep, Diabetic Retinopathy and Melatonin

University of Illinois at Chicago (Other)
Overall Status
Recruiting ID
University of Chicago (Other)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a randomized controlled study using melatonin for 8 weeks in patients with diabetic retinopathy on outcomes of sleep and circadian regulation

Study Design

Study Type:
Anticipated Enrollment :
36 participants
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blinded randomized controlled studyDouble blinded randomized controlled study
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participants and investigators are blinded.
Primary Purpose:
Official Title:
Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
Actual Study Start Date :
Feb 3, 2021
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control


Other: Placebo
Placebo will be given nightly for 8 weeks

Active Comparator: Melatonin


Drug: Melatonin
Melatonin 3 mg will be taken nightly for 8 weeks

Outcome Measures

Primary Outcome Measures

  1. Sleep pattern [14 days]

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

  2. Melatonin and Cortisol Rhythm [24 hours]

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

Eligibility Criteria


Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 University of Illinois at Chicago Chicago Illinois United States 60612

Sponsors and Collaborators

  • University of Illinois at Chicago
  • University of Chicago


None specified.

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Sirimon Reutrakul, Associate Professor, University of Illinois at Chicago Identifier:
Other Study ID Numbers:
  • 2020-1052
First Posted:
Sep 14, 2020
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022