NCT04547439 Sleep, Diabetic Retinopathy and Melatonin
| NCT ID | NCT04547439 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Illinois at Chicago |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2021-02-03 |
| Primary Completion | 2026-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2021-02-03 with a primary completion date of 2026-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study explores the use of melatonin in patients with diabetic retinopathy
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04547439 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 65 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04547439 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04547439 currently recruiting?
Yes, NCT04547439 is actively recruiting participants. Contact the research team at sreutrak@uic.edu for enrollment information.
Where is the NCT04547439 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT04547439 clinical trial?
NCT04547439 is sponsored by University of Illinois at Chicago. The trial plans to enroll 42 participants.
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