Gastrointestinal Symptoms in Children With Type 1 Diabetes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

- 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

Disqualifiers

- 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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

254 Participants
are grouped into 2 trial groups
Group A: Type 1 Diabetes Mellitus
Group B: Healthy Controls

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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