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โ† Trials
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Sleep, Diabetic Retinopathy and Melatonin

RecruitingPhase 2Ages 40 Years - 65 YearsAllUniversity of Illinois at Chicago
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In plain words

What the trial is, and whether it could suit you

This study explores the use of melatonin in patients with diabetic retinopathy

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1Cโ‰ฅ6.5%) * 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 (AHIโ‰ฅ 30 events/hour), * uncontrolled hypertension (blood pressure โ‰ฅ 160/100 mmHg), * uncontrolled diabetes (A1C โ‰ฅ 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.
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What it tests

  • Melatonin
  • Placebo
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Where

1 site
University of Illinois at Chicago
Chicago, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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