NCT04547439 · University of Illinois at Chicago
Sleep, Diabetic Retinopathy and Melatonin
What this study is about
This study explores the use of melatonin in patients with diabetic retinopathy
View original scientific description
This study explores the use of melatonin in patients with diabetic retinopathy
Interventions
DRUG
Melatonin
Melatonin 3 mg will be taken nightly for 8 weeks
OTHER
Placebo
Placebo will be given nightly for 8 weeks
Primary outcome measures
Sleep pattern
Time frame: 14 days
Sleep pattern: Sleep duration and sleep efficiency will be assessed by wrist actigraphy, to be worn by the participants for 14 days
Melatonin and Cortisol Rhythm
Time frame: 24 hours
Melatonin and cortisol pattern (peak times of the levels, dim light melatonin onset) will be assessed from 24 hour blood sampling
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Collaborators
University of Chicago
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations