Sleep, Diabetic Retinopathy and Melatonin

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04547439
• Other study ID #: 2020-1052
• Status: Recruiting
• Phase: Phase 2
• Start date: February 3, 2021
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: University of Illinois at Chicago
• Contact: Sirimon Reutrakul
• Phone: 3129966060
• Email: sreutrak[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Melatonin
Melatonin 3 mg will be taken nightly for 8 weeks

Other:
• Placebo
Placebo will be given nightly for 8 weeks

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep pattern	Sleep pattern: Sleep duration and sleep efficiency will be assessed by wrist actigraphy, to be worn by the participants for 14 days	14 days
Primary	Melatonin and Cortisol Rhythm	Melatonin and cortisol pattern (peak times of the levels, dim light melatonin onset) will be assessed from 24 hour blood sampling	24 hours