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Cognitive impairment, poor sleep quality, Alzheimer's disease and dementia are complications of uncontrolled type 1 diabetes (T1D). Melatonin; a hormone secreted from the pineal gland; previously associated with sleep and cognition; has recently been associated with insulin secretion and glucose homeostasis. People with diabetes have low serum melatonin levels. Moreover, melatonin adminstration was found to decrease anxiety, depression signs, and glycated hemoglobin (HbA1c) in diabetic rats . Hence, this study assessed the effect of melatonin adminstration add on therapy on excecutive functions, sleep quality and glycemic metrics among adolescents with T1D.
Methods: Seventy adolescents with T1D were assigned into two equal groups randomly, one received oral melatonin 3 mg once daily in addition to their insulin therapy and the other received insulin therapy and placebo. The nine item Patient Health Questionnaire (PHQ-9), the Wechsler Intelligence Scale for Children (WISC-children) Arabic editions and the Barkley Deficits in Executive Functioning Scale--Children and Adolescents (BDEFS-CA)- Parent-report rating scale were used for psychometric assessment. Fasting lipids profile, HbA1C and CGM metrics were assessed. Data were assessed at baseline, 3 and 6 months of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin group | Active Comparator | 35 adolescents with T1D |
|
| Placebo group | Placebo Comparator | 35 adolescents with T1D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin tablet 3 mg once daily | Dietary Supplement | Melatonin supplementation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in time in range | Change in the time in range using continuous glucose monitoring after 6 months compared to baseline. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| excecutive functions | change in the excecutive functions the Barkley Deficits in Executive Functioning Scale--Children and Adolescents after 6 months from baseline. The minimum score is 70 and the maximum is 280. The higher the score, the more the excecutive functions problems. | 6 months |
| psychometric assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | Egypt |
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| Placebo |
| Other |
Placebo |
|
change in the nine item patient health questionnaire (PHQ9) scale at 6 months from baseline. The scale consists of nine items, with minimum score 0 and maximum 27. The highest the score the more the depressive symptoms. |
| 6 months |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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