Diabetes MellitusSleepSupplementsNutrition and dietDrugPhase 2
What this study is
This study explores the use of melatonin in patients with diabetic retinopathy
What's being tested
- Melatonin
Intervention · DRUG
Melatonin 3 mg will be taken nightly for 8 weeks
- Placebo
Intervention · OTHER
Placebo will be given nightly for 8 weeks
Study details
- Official title
- Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
- Sponsor
- University of Illinois at Chicago
- Conditions
- Diabetes Mellitus · Diabetic Retinopathy
- Enrolling
- 42 people
- Starts
- 2021-02-03
- Est. completion
- 2026-06
- Design
- Triple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openUniversity of Illinois at Chicago
Chicago, Illinois, United States
- Sirimon Reutrakul, MD · Contact
Recruiting
Study team
Sponsor
University of Illinois at Chicago
Study ID 2020-1052
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.