Sleep, Diabetic Retinopathy and Melatonin

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Sep 7, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether melatonin, a natural hormone that helps regulate sleep, can benefit people with diabetic retinopathy, a condition that affects the eyes of those with diabetes. The study is looking for participants aged 40 to 65 who have type 2 diabetes and have been diagnosed with at least moderate diabetic retinopathy. If you fit this description and are currently managing your diabetes with medication, you might be eligible to join the trial.

Participants in the study will receive information about what to expect, including any treatments and tests involved. It's important to note that certain individuals may not qualify, such as those who have used melatonin before or have specific health conditions like severe heart problems or uncontrolled diabetes. If you’re interested in learning more about how melatonin may help protect your vision while managing diabetes, this trial could be a great opportunity to consider.

Gender

ALL

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.