Type 1 Diabetes (T1D)
Conditions
Keywords
Type 1 diabetes, Melatonin, Glycemic metrics, Excecutive functions, Sleep quality
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMelatonin tablet 3 mg once daily
Melatonin supplementation
OTHERPlacebo
Placebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Adolescents with T1DM according to the ISPAD 2022 guidelines (Couper et al., 2021) * Age: 12-18 years old.
Exclusion criteria
* Adolescents with other types of diabetes e.g. MODY, type 2 diabetes. * Adolescents with associated neurophsyciatric diseases e.g autism, ADHD * Adolescentswith other comorbidities e.g Auto immune throid disease,liver dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in time in range | 6 months | Change in the time in range using continuous glucose monitoring after 6 months compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| excecutive functions | 6 months | 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. |
| psychometric assessment | 6 months | 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. |
Countries
Egypt
Outcome results
None listed