Circadian Dysrhythmia, Circadian Rhythm Sleep Disorder, Unspecified Type, Diabetic Retinopathy, Melatonin
Conditions
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.
Interventions
DRUGMelatonin 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.
Sponsors
Steno Diabetes Center Copenhagen
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
A Double-blind, randomized, placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression of diabetic retinopathy, oscillary potential | 3 weeks | Progression of diabetic retinopati measured with electroretinography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed