Sleep, Diabetic Retinopathy and Melatonin

Phase 2

Recruiting

• Conditions: Diabetic Retinopathy; Diabetes Mellitus
• Interventions: Other: Placebo; Drug: Melatonin

• Registration Number: NCT04547439
• Lead Sponsor: 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

Study Timeline

• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-14
• Study Start: 2021-02-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Placebo
Melatonin	Melatonin	Melatonin

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States