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

• Status: Completed
• Trial end date: 2021-06-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glostrup University Hospital, Copenhagen
• Collaborators: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Treatments: Melatonin

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