Type 1 Diabetes (T1D)MS642/2024NCT07592442
Effect of Melatonin Supplementation on Excecutive Functions, Sleep Quality and Glycemic Metrics Among Adolescents With Type 1 Diabetes Mellitus
A study testing Melatonin tablet 3 mg once daily in people with Type 1 Diabetes (T1D), run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Melatonin tablet 3 mg once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Nov 2024to 24 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents with T1DM according to the ISPAD 2022 guidelines (Couper et al., 2021)
- Age: 12-18 years old.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Melatonin tablet 3 mg once daily, Placebo
- Keywords
- Type 1 diabetes, Melatonin, Glycemic metrics, Excecutive functions, Sleep quality
- Medical subject headings
- Diabetes Mellitus, Type 1, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin tablet 3 mg once dailyDietary supplement
Melatonin supplementation
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Melatonin group | Active comparator | 35 adolescents with T1D Receives: Dietary Supplement: Melatonin tablet 3 mg once daily |
| Placebo group | Placebo comparator | 35 adolescents with T1D Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time in range
Change in the time in range using continuous glucose monitoring after 6 months compared to baseline.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
psychometric assessment
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start24 Nov 2024
- Primary completion24 Nov 2025
- Study completion24 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran yousef, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592442
- Sponsor's protocol ID
- Melatonin T1D
- Acronym
- MS642/2024
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin Supplementation on Excecutive Functions, Sleep Quality and Glycemic Metrics Among Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07592442
- Acronym / sponsor ID
- MS642/2024 / Melatonin T1D
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Type 1 diabetes, Melatonin, Glycemic metrics, Excecutive functions, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Jan 2026 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Active comparator | Dietary Supplement: Melatonin tablet 3 mg once daily35 adolescents with T1D |
| Placebo group | Placebo comparator | Other: Placebo35 adolescents with T1D |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents with T1DM according to the ISPAD 2022 guidelines (Couper et al., 2021)
- Age: 12-18 years old.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin tablet 3 mg once dailyMelatonin supplementation | Dietary supplement | Melatonin group |
| PlaceboPlacebo | Other | Placebo group |
Primary outcome
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.
2 secondary outcomes
excecutive functions
Time frame: 6 months
psychometric assessment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin tablet 3 mg once daily in people with Type 1 Diabetes (T1D), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time in range (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.