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Completed

NCT Number: NCT07592442

Effect of Melatonin Supplementation on Excecutive Functions, Sleep Quality and Glycemic Metrics Among Adolescents With Type 1 Diabetes Mellitus

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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin tablet 3 mg once daily

Dietary Supplement

Melatonin supplementation

Placebo

Other

Placebo

Primary outcomes

  1. Change in time in range

    Time frame: 6 months

    Change in the time in range using continuous glucose monitoring after 6 months compared to baseline.

Secondary outcomes

  1. excecutive functions

    Time frame: 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.

  2. psychometric assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Acronym: MS642/2024

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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