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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03478306
Other study ID # DR2
Secondary ID 2015-003955-23
Status Completed
Phase Phase 3
First received
Last updated
Start date March 27, 2018
Est. completion date June 12, 2021

Study information

Verified date July 2021
Source Glostrup University Hospital, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date June 12, 2021
Est. primary completion date June 12, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Denmark Department of Ophthalmology, Rigshospitalet-Glostrup Glostrup RegionH

Sponsors (2)

Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression of diabetic retinopathy, oscillary potential Progression of diabetic retinopati measured with electroretinography 3 weeks
Secondary Post-illumination pupillary light response Melanopsin-mediated pupillary response 3 weeks
Secondary Circadian photoentrainment Salivary melatonin level and sleep assessment 3 weeks
Secondary Retinal structure Retinal structure assessed by optical coherence tomography 3 weeks
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