Sleep, Diabetic Retinopathy and Melatonin

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

Sponsors

Lead Sponsor: University of Illinois at Chicago

Collaborator: University of Chicago

Source University of Illinois at Chicago
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

Overall Status Not yet recruiting
Start Date January 2021
Completion Date June 2026
Primary Completion Date December 2025
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Sleep pattern 14 days
Melatonin and Cortisol Rhythm 24 hours
Enrollment 36
Condition
Intervention

Intervention Type: Drug

Intervention Name: Melatonin

Description: Melatonin 3 mg will be taken nightly for 8 weeks

Arm Group Label: Melatonin

Intervention Type: Other

Intervention Name: Placebo

Description: Placebo will be given nightly for 8 weeks

Arm Group Label: Control

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.

Gender: All

Minimum Age: 40 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Contact

Last Name: Sirimon Reutrakul

Phone: 3129966060

Email: [email protected]

Location
Facility: University of Illinois at Chicago
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Illinois at Chicago

Investigator Full Name: Sirimon Reutrakul

Investigator Title: Associate Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control

Type: Active Comparator

Description: Placebo

Label: Melatonin

Type: Active Comparator

Description: Melatonin

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Double blinded randomized controlled study

Primary Purpose: Other

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description: Participants and investigators are blinded.

Source: ClinicalTrials.gov