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OpenTrials
Completed

NCT Number: NCT03478306

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

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Chronobiology Disorders Circadian Dysrhythmia Circadian Rhythm Sleep Disorder, Unspecified Type Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Dyssomnias Endocrine System Diseases Eye Diseases Melatonin Mental Disorders Nervous System Diseases Occupational Diseases Retinal Diseases Sleep Disorders, Circadian Rhythm Sleep Wake Disorders Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Ophthalmology, Rigshospitalet-Glostrup

Glostrup Municipality, RegionH, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin 4 mg Tablet

Drug

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.

Primary outcomes

  1. Progression of diabetic retinopathy, oscillary potential

    Time frame: 3 weeks

    Progression of diabetic retinopati measured with electroretinography

Secondary outcomes

  1. Post-illumination pupillary light response

    Time frame: 3 weeks

    Melanopsin-mediated pupillary response

  2. Circadian photoentrainment

    Time frame: 3 weeks

    Salivary melatonin level and sleep assessment

  3. Retinal structure

    Time frame: 3 weeks

    Retinal structure assessed by optical coherence tomography

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Collaborators

  • Steno Diabetes Center Copenhagen

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2018
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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