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Recruiting Phase 2 NCT04547439

Sleep, Diabetic Retinopathy and Melatonin

Phase 2 – studying effectiveness and dosage
Conditions: Diabetes Mellitus Diabetic Retinopathy

Sponsor: University of Illinois at Chicago

trial.available_in: БГ
Overview
This study explores the use of melatonin in patients with diabetic retinopathy
Description
This is a randomized controlled study using melatonin for 8 weeks in patients with diabetic retinopathy on outcomes of sleep and circadian regulation
Who can participate
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.
Interventions
Melatonin
DRUG
Placebo
OTHER
Locations 1
United States (1)
University of Illinois at Chicago
Chicago , Illinois
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
03.02.2021
Completion date
01.06.2026
Registry ID
NCT04547439
Source
clinicaltrials.gov
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