NCT04547439

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus

Timeline
0mo left

Started Feb 2021

Longer than P75 for phase_2 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 3, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

June 27, 2020

Last Update Submit

April 20, 2026

Conditions

Diabetes MellitusDiabetic Retinopathy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Control

ACTIVE COMPARATOR

Placebo

Other: Placebo

Melatonin

ACTIVE COMPARATOR

Melatonin

Drug: Melatonin

Interventions

MelatoninDRUG

Melatonin 3 mg will be taken nightly for 8 weeks

Melatonin
PlaceboOTHER

Placebo will be given nightly for 8 weeks

Control

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)
  • years of age
  • Diabetic retinopathy of at least moderate degree

You may not qualify if:

  • 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),
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Related 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.

    PMID: 15649737BACKGROUND

  • 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.

    PMID: 14655926BACKGROUND

  • 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.

    PMID: 7658780BACKGROUND

  • 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.

    PMID: 29275919BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Sirimon Reutrakul

CONTACT

3129966060sreutrak@uic.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants and investigators are blinded.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Double blinded randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 27, 2020

First Posted

September 14, 2020

Study Start

February 3, 2021

Primary Completion

February 2, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)