Sleep, Diabetic Retinopathy and Melatonin

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Препарат Melatonin
  Melatonin 3 mg will be taken nightly for 8 weeks
• Другое Placebo
  Placebo will be given nightly for 8 weeks

Первичные конечные точки

• Sleep pattern [Срок оценки: 14 days]
• Melatonin and Cortisol Rhythm [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Illinois at Chicago — Chicago

Публикации

• 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

Идентификаторы

NCT: NCT04547439 · 2020-1052

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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