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Not yet recruitingNCT07845175Updated Sep 28, 2026

Gastrointestinal Symptoms in Children With Type 1 Diabetes

An observational study in Type 1 Diabetes Mellitus, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
254
Ages
1 Year to 18 Years
Sex
All
01

Study summary

This cross-sectional study aims to assess the frequency and types of gastrointestinal symptoms in children with type 1 diabetes mellitus compared with age- and sex-matched healthy controls.

Read the detailed description

Gastrointestinal symptoms are relatively common among children with type 1 diabetes mellitus and may affect nutritional status and glycemic control. This observational study will include children aged 1 to 18 years with type 1 diabetes mellitus and age- and sex-matched healthy controls.

Participants will be assessed for the presence and types of gastrointestinal symptoms using a structured history and clinical examination.

02

Conditions studied

  • Type 1 Diabetes Mellitus

Keywords

  • Type 1 diabetes
  • Children
  • Assiut
  • Gastrointestinal symptoms
03

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children and adolescents aged 1-18 years with type 1 diabetes mellitus attending Assiut University Children's Hospital, and age- and sex-matched healthy controls.

Inclusion criteria

  • - Age 1 to 18 years
  • Diagnosis of type 1 diabetes mellitus according to American Diabetes Association criteria (cases)
  • Age- and sex-matched healthy children (controls)
  • Written informed consent from parents or legal guardians

Exclusion criteria

Exclusion Criteria:

  • - Diabetes mellitus other than type 1
  • Chronic liver, pancreatic, renal, or neurological disease that may contribute to gastrointestinal symptoms
  • Acute gastrointestinal infection at the time of assessment
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
254 participants (estimated)
Patient registry
No

Groups and cohorts

  • Type 1 Diabetes Mellitus

    Children with type 1 diabetes mellitus who will be assessed for gastrointestinal symptoms.

  • Healthy Controls

    Age- and sex-matched healthy children without diabetes who will undergo the same symptom assessment.

05

What researchers measure

Primary outcomes

  1. Prevalence of gastrointestinal symptoms

    Proportion of children with at least one gastrointestinal symptom in the type 1 diabetes group compared with healthy controls.

    Time frame: Baseline

Secondary outcomes

  1. Prevalence of abdominal pain

    Proportion of children reporting abdominal pain.

    Time frame: Baseline

  2. Prevalence of nausea

    Proportion of children reporting nausea.

    Time frame: Baseline

  3. Prevalence of vomiting

    Proportion of children reporting vomiting.

    Time frame: Baseline

  4. Prevalence of constipation

    Proportion of children reporting constipation.

    Time frame: Baseline

  5. Prevalence of diarrhea

    Proportion of children reporting diarrhea.

    Time frame: Baseline

  6. Prevalence of bloating

    Proportion of children reporting bloating.

    Time frame: Baseline

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07845175
Lead sponsor
Assiut University
Responsible party
Asmaa Eid Mohammed (Resident Physician, Department of Pediatrics, Assiut University) — Principal investigator
First posted
Sep 28, 2026
Start date
Sep 26, 2026 (estimated)
Primary completion
Sep 26, 2027 (estimated)
Completion
Feb 20, 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Asmaa E Mohamed, Resident
Contact
Asmaa.18313446@med.aun.edu.eg
+20 10 25714951
Hanaa A Mohammed, prof
study chair · Pediatrics Department, Assiut University Hospitals

Oversight

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 Sep 2026. You cannot join it, but the record below documents what was studied.

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