CClinicalTrials.gg
Not yet recruitingNCT07096804Updated Jul 31, 2025

Effects of Ramadan Fasting on Type 1 Diabetic Children

An observational study in Diabtes Mellitus Type 1, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2025-07-31.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
Up to 17 Years
Sex
All
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Study 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 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 .

02

Conditions studied

  • Diabtes Mellitus Type 1
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children with type 1 diabetes

Eligibility criteria

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

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07096804
Lead sponsor
Assiut University
Responsible party
Ahmed Mahmoud Ismail Rashed (Resident Doctor, Assiut University) — Principal investigator
First posted
Jul 31, 2025
Start date
Feb 25, 2026 (estimated)
Primary completion
Feb 25, 2028 (estimated)
Completion
May 25, 2028 (estimated)
Last update
Jul 31, 2025

Study contacts

Ahmed Mahmoud Ismail, Resident Doctor
Contact
dramedmahmoud099@gmail.com
+201152175343
Hanaa Abdelateef Mohamad, Professor
study director · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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