RECRUITING

Sleep, Diabetic Retinopathy and Melatonin

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-02-03

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04547439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Sirimon Reutrakul

CONTACT

3129966060

sreutrak@uic.edu

Study Locations (Sites)

University of Illinois at Chicago

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-03

Study Completion Date2026-06

Study Record Updates

Study Start Date2021-02-03

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Diabetes Mellitus
Diabetic Retinopathy