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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003955-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Steno Diabetes Center Copenhagen | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Melatonin, 1 tablet (4 mg), every evening 2 hours before bed in 21 days. |
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| Arm 2 | Placebo Comparator | Place, 1 tablet (4 mg), every evening 2 hours before bed in 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of diabetic retinopathy, oscillary potential | Progression of diabetic retinopati measured with electroretinography | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Post-illumination pupillary light response | Melanopsin-mediated pupillary response | 3 weeks |
| Circadian photoentrainment | Salivary melatonin level and sleep assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shakoor Ba-Ali | Department of Ophthalmology, Rigshospitalet-Glostrup | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Rigshospitalet-Glostrup | Glostrup Municipality | RegionH | 2600 | Denmark |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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A Double-blind, randomized, placebo-controlled trial
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Melatonin and placebo tablets are identicle in terms of taste, colour, tablet-size etc. The tablets are packed and masked by external manufacturer.
| 3 weeks |
| Retinal structure | Retinal structure assessed by optical coherence tomography | 3 weeks |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009784 | Occupational Diseases |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |