Sleep, Diabetic Retinopathy and Melatonin
This study explores the use of melatonin in patients with diabetic retinopathy
Conditions:
🦠 Diabetes Mellitus 🦠 Diabetic Retinopathy
🗓️ Study Start (Actual) 3 February 2021
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) June 2026
👥 Enrollment (Estimated) 36
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 40 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 27 June 2020
  • First Submitted that Met QC Criteria 7 September 2020
  • First Posted 14 September 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 October 2023
  • Last Update Posted 31 October 2023
  • Last Verified October 2023