Using melatonin to improve sleep in patients with diabetic retinopathy
Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
This study tests if taking melatonin can help people with diabetic retinopathy sleep better over eight weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04547439 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of melatonin on sleep and circadian regulation in patients with diabetic retinopathy. It is a randomized controlled trial where participants will receive either melatonin or a placebo for a duration of 8 weeks. The focus is on understanding how melatonin may influence sleep quality and related outcomes in individuals suffering from this eye condition associated with diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40-65 with type 2 diabetes and moderate to severe diabetic retinopathy.
Not a fit: Patients with severe chronic conditions, significant depressive symptoms, or those currently using melatonin or certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to improve sleep quality and potentially slow the progression of diabetic retinopathy in affected patients.
How similar studies have performed: While the use of melatonin in other contexts has shown promise, this specific approach in diabetic retinopathy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Sirimon Reutrakul
- Email: sreutrak@uic.edu
- Phone: 3129966060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.