ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03478306
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Steno Diabetes Center
Information provided by (Responsible Party):
Shakoor Ba-Ali, Rigshospitalet, Denmark

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A 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 : March 27, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

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.




Primary Outcome Measures :
  1. Progression of diabetic retinopathy, oscillary potential [ Time Frame: 3 weeks ]
    Progression of diabetic retinopati measured with electroretinography


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478306


Contacts
Contact: Shakoor Ba-Ali, MD +4531614923 shakoor@shakoor.dk

Locations
Denmark
Department of Ophthalmology, Rigshospitalet-Glostrup Recruiting
Glostrup, RegionH, Denmark, 2600
Contact: Shakoor Ba-Ali    +4531614923    shakoor@shakoor.dk   
Principal Investigator: Shakoor Ba-Ali, MD         
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Steno Diabetes Center
Investigators
Principal Investigator: Shakoor Ba-Ali Department of Ophthalmology, Rigshospitalet-Glostrup

Responsible Party: Shakoor Ba-Ali, Principal Investigator, Medical Doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03478306     History of Changes
Other Study ID Numbers: DR2
2015-003955-23 ( EudraCT Number )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Diabetic Angiopathies
Sleep Wake Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants