Type 1 Diabetes MellitusNCT07845175
Gastrointestinal Symptoms in Children With Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 254 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 20 Feb 2028
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- - 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
Who cannot join
- - 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 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: Frequency of Gastrointestinal Symptoms in Children With Type 1 Diabetes Mellitus Compared With Healthy Controls
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.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes, Children, Assiut, Gastrointestinal symptoms
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of gastrointestinal symptoms
Proportion of children with at least one gastrointestinal symptom in the type 1 diabetes group compared with healthy controls.
Measured: Baseline
Secondary outcomes (6)
Prevalence of abdominal pain
Proportion of children reporting abdominal pain.
Measured: Baseline
Prevalence of nausea
Proportion of children reporting nausea.
Measured: Baseline
Prevalence of vomiting
Proportion of children reporting vomiting.
Measured: Baseline
Prevalence of constipation
Proportion of children reporting constipation.
Measured: Baseline
Prevalence of diarrhea
Proportion of children reporting diarrhea.
Measured: Baseline
Prevalence of bloating
Proportion of children reporting bloating.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion20 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Eid Mohammed, Assiut University
- Investigators
- Hanaa A Mohammed, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845175
- Sponsor's protocol ID
- GI-T1DM-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Gastrointestinal Symptoms in Children With Type 1 Diabetes Mellitus Compared With Healthy Controls
- ClinicalTrials.gov ID
- NCT07845175
- Acronym / sponsor ID
- GI-T1DM-Assiut-2026
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes, Children, Assiut, Gastrointestinal symptoms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Sep 2026 (estimated)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 20 Feb 2028 (estimated)
- First posted
- 28 Sep 2026 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (3 listed)
- - 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
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
Prevalence of gastrointestinal symptoms
Time frame: Baseline
Proportion of children with at least one gastrointestinal symptom in the type 1 diabetes group compared with healthy controls.
6 secondary outcomes
Prevalence of abdominal pain
Time frame: Baseline
Prevalence of nausea
Time frame: Baseline
Prevalence of vomiting
Time frame: Baseline
Prevalence of constipation
Time frame: Baseline
Prevalence of diarrhea
Time frame: Baseline
Prevalence of bloating
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 28 Sep 2026.
- Individual participant dataSharing planned: No
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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 A Mohammed, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, 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?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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 28 Sep 2026. 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 Asmaa E Mohamed, Resident (+20 10 25714951, Asmaa.18313446@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of gastrointestinal symptoms (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 28 Sep 2026.