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Diabtes Mellitus Type 1NCT07096804

Effects of Ramadan Fasting on Type 1 Diabetic Children

An observational study of Diabtes Mellitus Type 1, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

assess the effects of Ramadan fasting on Type 1 diabetic children, fasting on their own, and to assess the validity of IDF-DAR risk calculator as a predictor of complications. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Diabtes Mellitus Type 1
How many people
100 participants
Where
No sites listed yet
Study dates
25 Feb 2026to 25 May 2028
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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 Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children with type 1 diabetes

Inclusion Criteria: Children aged <18 years with established type 1 diabetes, on a stable insulin regimen (multiple daily injections or insulin pump) fasting Ramadan on their welling.

  • Another comparable number of age and sex matched type 1 diabetic children not fasting will be included as a control.

Exclusion Criteria: patients with type 2 diabetes or seconadry diabetes

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ahmed Mahmoud Ismail, Resident Doctor contact

+201152175343

dramedmahmoud099@gmail.com

About this study

Official title: Effects of Ramadan Fasting on Type 1 Diabetic Children in Assiut Governorate, Egypt

assess the effects of Ramadan fasting on Type 1 diabetic children, fasting on their own, and to assess the validity of IDF-DAR risk calculator as a predictor of complications.

Read the detailed description

Fasting during Ramadan holds profound religious, spiritual, and social significance for Muslims worldwide. This divine decree underscores the purpose of fasting, not merely as a physical exercise but as a means to develop spiritual consciousness and self-restraint. However, the Quran also provides allowances for those who are ill or incapable of fasting. This reflects Islam's principle of ḥifẓ al-nafs - the preservation of life, which takes precedence when health may be endangered . The practice of fasting during Ramadan entails abstaining from food, drink, medications, and other specific activities from dawn until sunset each day for a lunar month. For healthy adults, this fasting pattern generally carries spiritual and even certain metabolic benefits. However, for individuals with chronic diseases such as diabetes mellitus, particularly type 1 diabetes mellitus (T1DM) in children, fasting can present considerable challenges and potential dangers if not approached with caution and proper planning . The metabolic complexity of T1DM, especially in the pediatric population, demands careful medical and religious considerations before embarking on fasting .To guide healthcare professionals, the International Diabetes Federation (IDF) in collaboration with the Diabetes and Ramadan International Alliance (DaR) have developed comprehensive guidelines for managing patients with diabetes during Ramadan. The most critical component of these guidelines is a detailed risk stratification model, which categorizes patients into low, moderate, or high-risk groups based on various clinical factors . According to these guidelines, most children with T1DM - especially those with recent severe hypoglycemia, diabetic ketoacidosis, poor glycemic control, or limited access to monitoring technology - are classified as high-risk and are generally advised against fasting .Despite these risks, many children and families express a strong desire to participate in fasting as part of their religious practice. Studies have found that with appropriate preparation, some older children and adolescents with well-controlled T1DM could fast successfully without severe adverse events under close medical supervision . However, these studies also emphasized the importance of continuous glucose monitoring (CGM), flexible insulin regimens, and careful dietary planning to minimize glycemic excursions during fasting .Additionally, many children with type 1 diabetes in school settings express a strong desire to fast during Ramadan . This is often driven by a sense of embarrassment or peer pressure, as they do not want to appear different from their classmates. Religious motivation also plays a significant role, as these children wish to fulfill the spiritual obligation of fasting like their peers and family members .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • Change in HbA1c from baseline to 4 weeks post-Ramadan.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start25 Feb 2026 (estimated)
  3. Primary completion25 Feb 2028 (estimated)
  4. Study completion25 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07096804
Sponsor's protocol ID
Diabetes and Ramadan fasting
Status last verified
Jul 2025
First submitted
22 Jul 2025
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabtes Mellitus Type 1, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed Mahmoud Ismail, Resident Doctor (+201152175343, dramedmahmoud099@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• Change in HbA1c from baseline to 4 weeks post-Ramadan. (time frame: Baseline). 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 31 Jul 2025.

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