Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm

Sponsor

Glostrup University Hospital, Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT03478306

Collaborator

Steno Diabetes Center Copenhagen (Other)

Enrollment

Location

Arms

38.5

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the effect of melatonin 4 mg on circadian rhythm and visual function of patients with diabetes mellitus. Half of the patients will receive melatonin (arm-1) and the other half will receive placebo (arm-2), both groups in 3 weeks. After a week of washout, the patients will cross over to the other treatment arm.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy Melatonin Circadian Dysrhythmia Circadian Rhythm Sleep Disorder, Unspecified Type	Drug: Melatonin 4 mg Tablet	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

A Double-blind, randomized, placebo-controlled trialA Double-blind, randomized, placebo-controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Melatonin and placebo tablets are identicle in terms of taste, colour, tablet-size etc. The tablets are packed and masked by external manufacturer.

Primary Purpose:

Treatment

Official Title:

Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm

Actual Study Start Date :

Mar 27, 2018

Actual Primary Completion Date :

Jun 12, 2021

Actual Study Completion Date :

Jun 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 Melatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.	Drug: Melatonin 4 mg Tablet Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.
Placebo Comparator: Arm 2 Place, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.	Drug: Melatonin 4 mg Tablet Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.

Arm

Intervention/Treatment

Active Comparator: Arm 1

Melatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.

Drug: Melatonin 4 mg Tablet

Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.

Placebo Comparator: Arm 2

Place, 1 tablet (4 mg), every evening 2 hours before bed in 21 days.

Drug: Melatonin 4 mg Tablet

Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.

Outcome Measures

Primary Outcome Measures

Progression of diabetic retinopathy, oscillary potential [3 weeks]
Progression of diabetic retinopati measured with electroretinography

Secondary Outcome Measures

Post-illumination pupillary light response [3 weeks]
Melanopsin-mediated pupillary response
Circadian photoentrainment [3 weeks]
Salivary melatonin level and sleep assessment
Retinal structure [3 weeks]
Retinal structure assessed by optical coherence tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diabetic patients
Age range 40-75 years
Participant should be legally competent

Exclusion Criteria:

Other known eye disease.
Eye disease manifestation during ocular examination.
Competing neurologic and systemic conditions affecting retina.
Use of any drugs influencing pupillary light reflex and sleep pattern.
Refractive error with need of > 6 diopter lenses.
Pregnancy
Alcohol consumption during the trial
Lack of cooperation
Allergy to melatonin and/or preservatives in melatonin and placebo
Reduced hepatic function
Fluvoxamin intake due to drug interaction
Consumption of Alpha-1 and beta-1 adnergic antagoists.
Alcohol consumption during treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, Rigshospitalet-Glostrup	Glostrup	RegionH	Denmark	2600

Sponsors and Collaborators

Glostrup University Hospital, Copenhagen
Steno Diabetes Center Copenhagen

Investigators

Principal Investigator: Shakoor Ba-Ali, Department of Ophthalmology, Rigshospitalet-Glostrup

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shakoor Ba-Ali, Principal Investigator, Medical Doctor, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT03478306

Other Study ID Numbers:

DR2
2015-003955-23

First Posted:

Mar 27, 2018

Last Update Posted:

Aug 2, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Wake Disorders

Parasomnias

Sleep Disorders, Circadian Rhythm

Retinal Diseases

Diabetic Retinopathy

Melatonin

Study Results

No Results Posted as of Aug 2, 2021