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.
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.
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 .
- Conditions
- Diabtes Mellitus Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
- First posted31 Jul 2025
- Study start25 Feb 2026 (estimated)
- Primary completion25 Feb 2028 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabtes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Ismail Rashed, Assiut University
- Investigators
- Hanaa Abdelateef Mohamad, Professor, Study director, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ramadan Fasting on Type 1 Diabetic Children in Assiut Governorate, Egypt
- ClinicalTrials.gov ID
- NCT07096804
- Acronym / sponsor ID
- Diabetes and Ramadan fasting
- Conditions
- Diabtes Mellitus Type 1
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 25 Feb 2028 (estimated)
- Study completion
- 25 May 2028 (estimated)
- First posted
- 31 Jul 2025 (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.
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.
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 .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• Change in HbA1c from baseline to 4 weeks post-Ramadan.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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.
Hanaa Abdelateef Mohamad, Professor study director
Assiut University
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.