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Sleep, Diabetic Retinopathy and Melatonin

Primary Purpose

Diabetes Mellitus, Diabetic Retinopathy

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Melatonin

Placebo

About this trial

This is an interventional other trial for Diabetes Mellitus

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Illinois at ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Control

Melatonin

Arm Description

Placebo

Melatonin

Outcomes

Primary Outcome Measures

Sleep pattern

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

Melatonin and cortisol pattern (peak times of the levels, dim light melatonin onset) will be assessed from 24 hour blood sampling

Secondary Outcome Measures

Full Information

NCT ID

NCT04547439

First Posted

June 27, 2020

Last Updated

May 16, 2022

Sponsor

University of Illinois at Chicago

Collaborators

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT04547439

Brief Title

Sleep, Diabetic Retinopathy and Melatonin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 3, 2021 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Chicago

Collaborators

University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Diabetic Retinopathy

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Double blinded randomized controlled study

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Participants and investigators are blinded.

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Placebo

Arm Title

Melatonin

Arm Type

Active Comparator

Arm Description

Melatonin

Intervention Type

Drug

Intervention Name(s)

Melatonin

Intervention Description

Melatonin 3 mg will be taken nightly for 8 weeks

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo will be given nightly for 8 weeks

Primary Outcome Measure Information:

Title

Sleep pattern

Description

Sleep pattern: Sleep duration and sleep efficiency will be assessed by wrist actigraphy, to be worn by the participants for 14 days

Time Frame

14 days

Title

Melatonin and Cortisol Rhythm

Description

Melatonin and cortisol pattern (peak times of the levels, dim light melatonin onset) will be assessed from 24 hour blood sampling

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sirimon Reutrakul

Phone

3129966060

sreutrak@uic.edu

Facility Information:

Facility Name

University of Illinois at Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sirimon Reutrakul, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15649737

Citation

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.

Results Reference

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PubMed Identifier

14655926

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.

Results Reference

background

PubMed Identifier

7658780

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.

Results Reference

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PubMed Identifier

29275919

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.

Results Reference

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Sleep, Diabetic Retinopathy and Melatonin

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