Clinical trial NCT04547439: Sleep, Diabetic Retinopathy and Melatonin
Official title: Sleep and Circadian Regulation in Diabetic Retinopathy: the Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2020-09-14
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized controlled study
Primary purpose: OTHER

Brief summary: 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

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.

Primary outcomes:
measure: Sleep pattern
timeFrame: 14 days
measure: Melatonin and Cortisol Rhythm
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.