Effect of Melatonin Supplementation on Excecutive Functions, Sleep Quality and Glycemic Metrics Among Adolescents With Type 1 Diabetes Mellitus (MS642/2024)

May 14, 2026 updated by: Nouran yousef, Ain Shams University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Melatonin group
35 adolescents with T1D
Dietary supplement: Melatonin tablet 3 mg once daily
Melatonin supplementation
Placebo Comparator: Placebo group
35 adolescents with T1D
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2024

Primary Completion (Actual)

November 24, 2025

Study Completion (Actual)

January 24, 2026

Study Registration Dates

First Submitted

May 9, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Melatonin T1D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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