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

NCT07592442 | Completed

• 1 other identifier: Melatonin T1D
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes (T1D)

Keywords

Type 1 diabetes; Melatonin; Glycemic metrics; Excecutive functions; Sleep quality

Outcome Measures

Primary Outcomes (1)

• Change in time in range

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

  6 months

Secondary Outcomes (2)

• excecutive functions

  6 months

• psychometric assessment

  6 months

Study Arms (2)

Melatonin group

ACTIVE COMPARATOR

35 adolescents with T1D

Dietary Supplement: Melatonin tablet 3 mg once daily

Placebo group

PLACEBO COMPARATOR

35 adolescents with T1D

Other: Placebo

Interventions

Melatonin tablet 3 mg once daily DIETARY_SUPPLEMENT

Melatonin supplementation

Melatonin group

Placebo OTHER

Placebo

Placebo group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents with T1DM according to the ISPAD 2022 guidelines (Couper et al., 2021)
• Age: 12-18 years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor and manager of the pediatric diabetes, endocrinology and metabolism unit

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 18, 2026
• Study Start: November 24, 2024
• Primary Completion: November 24, 2025
• Study Completion: January 24, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)