Recruiting NCT04547439

Sleep, Diabetic Retinopathy and Melatonin

Phase II Interventional Diabetes Mellitus Diabetic Retinopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Melatonin, Placebo.
Who it may be relevant to: Registry conditions: Diabetes Mellitus, Diabetic Retinopathy. Basic parameters: 40 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation

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

Detailed description

This is a randomized controlled study using melatonin for 8 weeks in patients with diabetic retinopathy on outcomes of sleep and circadian regulation

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

Brzezinski A, Vangel MG, Wurtman RJ, Norrie G, Zhdanova I, Ben-Shushan A, Ford I. Effects of exogenous melatonin on sleep: a meta-analysis. Sleep Med Rev. 2005 Feb;9(1):41-50. doi: 10.1016/j.smrv.2004.06.004. PMID 15649737
Singer C, Tractenberg RE, Kaye J, Schafer K, Gamst A, Grundman M, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer's disease. Sleep. 2003 Nov 1;26(7):893-901. doi: 10.1093/sleep/26.7.893. PMID 14655926
Garfinkel D, Laudon M, Nof D, Zisapel N. Improvement of sleep quality in elderly people by controlled-release melatonin. Lancet. 1995 Aug 26;346(8974):541-4. doi: 10.1016/s0140-6736(95)91382-3. PMID 7658780
Raygan F, Ostadmohammadi V, Bahmani F, Reiter RJ, Asemi Z. Melatonin administration lowers biomarkers of oxidative stress and cardio-metabolic risk in type 2 diabetic patients with coronary heart disease: A randomized, double-blind, placebo-controlled trial. Clin Nutr. 2019 Feb;38(1):191-196. doi: 10.1016/j.clnu.2017.12.004. Epub 2017 Dec 12. PMID 29275919

NCT: NCT04547439 · 2020-1052