Diabetes Mellitus, Type 1NCT07807553
Liver Function Test Abnormalities in Pediatric Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1 and Liver Diseases, run by Assiut University.
Trial summary
This cross-sectional study aims to determine the frequency, pattern, and predictors of liver function test abnormalities among children and adolescents with type 1 diabetes mellitus attending Assiut University Children Hospital. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Liver Diseases
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2026to 1 Jun 2028
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents aged 1 to 18 years with confirmed type 1 diabetes mellitus attending the Pediatric Endocrinology and Diabetes Clinic and Pediatric Wards of Assiut University Children Hospital.
Who may be able to join
- - Age 1 to 18 years
- Confirmed type 1 diabetes mellitus on insulin therapy
- Willingness of parents/guardians to provide informed consent
Who cannot join
- - Pre-existing chronic liver disease
- Type 2 diabetes mellitus
- Acute systemic infections
- Concurrent use of hepatotoxic medications
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, Pattern and Predictors of Liver Function Test Abnormalities in Children and Adolescents With Type 1 Diabetes Mellitus
This cross-sectional study aims to determine the frequency, pattern, and predictors of liver function test abnormalities among children and adolescents with type 1 diabetes mellitus attending Assiut University Children Hospital.
Read the detailed description
Type 1 diabetes mellitus is associated with hepatic involvement, including glycogenic hepatopathy and metabolic dysfunction-associated steatotic liver disease. Liver function test abnormalities are reported in a significant proportion of pediatric patients with type 1 diabetes, yet data from Egypt remain limited.
This cross-sectional study will include children and adolescents aged 1 to 18 years with confirmed type 1 diabetes mellitus on insulin therapy. Clinical data, anthropometric measurements, and laboratory investigations including liver function tests will be collected. The study will determine the frequency and patterns of LFT abnormalities and identify independent clinical and biochemical predictors.
- Conditions
- Diabetes Mellitus, Type 1, Liver Diseases
- Keywords
- Type 1 diabetes mellitus, Liver function tests, Adolescents, Children, Predictors
- Medical subject headings
- Diabetes Mellitus, Type 1, Liver Diseases
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 |
|---|---|---|
| Single cohort: Children and adolescents with type 1 diabetes mellitus | Children and adolescents aged 1-18 years with confirmed type 1 diabetes mellitus on insulin therapy who will undergo clinical assessment and laboratory evaluation of liver function tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of liver function test abnormalities
Proportion of children and adolescents with type 1 diabetes mellitus who have abnormal liver function tests (elevated ALT, AST, GGT, ALP, or bilirubin, or decreased albumin), expressed as percentage.
Measured: Baseline
Secondary outcomes (3)
Pattern of LFT abnormalities
Characterization of LFT abnormality patterns (hepatocellular, cholestatic, mixed, or synthetic dysfunction)
Measured: Baseline
Independent predictors of LFT abnormalities
Clinical and biochemical factors independently associated with abnormal liver function tests using multivariable logistic regression analysis.
Measured: Baseline
Association with glycemic control
Comparison of LFT abnormalities between patients with good and poor glycemic control based on HbA1c levels.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start2 Sep 2026 (estimated)
- Primary completion2 Oct 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Raey Heshmat Mahmoud, Assiut University
- Investigators
- Kotb A Metwalley, prof, Study chair, pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807553
- Sponsor's protocol ID
- LFT-T1DM-Pediatric-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rousseau T, Venture G, Hernandez V. Latent Space Representation of Human Movement: Assessing the Effects of Fatigue. Sensors (Basel). 2024 Dec 4;24(23):7775. doi: 10.3390/s24237775.
PubMed 39686311Martinello K, Sciaccaluga M, Morace R, Mascia A, Arcella A, Esposito V, Fucile S. Loss of constitutive functional gamma-aminobutyric acid type A-B receptor crosstalk in layer 5 pyramidal neurons of human epileptic temporal cortex. Epilepsia. 2018 Feb;59(2):449-459. doi: 10.1111/epi.13991. Epub 2017 Dec 28.
PubMed 29283181Vidal-Lletjos S, Andriamihaja M, Blais A, Grauso M, Lepage P, Davila AM, Gaudichon C, Leclerc M, Blachier F, Lan A. Mucosal healing progression after acute colitis in mice. World J Gastroenterol. 2019 Jul 21;25(27):3572-3589. doi: 10.3748/wjg.v25.i27.3572.
PubMed 31367158Sanyal U, Jagirdar BR. Metal and alloy nanoparticles by amine-borane reduction of metal salts by solid-phase synthesis: atom economy and green process. Inorg Chem. 2012 Dec 3;51(23):13023-33. doi: 10.1021/ic3021436. Epub 2012 Nov 15.
PubMed 23153303
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency, Pattern and Predictors of Liver Function Test Abnormalities in Children and Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07807553
- Acronym / sponsor ID
- LFT-T1DM-Pediatric-Assiut-2026
- Conditions
- Diabetes Mellitus, Type 1, Liver Diseases
- Keywords
- Type 1 diabetes mellitus, Liver function tests, Adolescents, Children, Predictors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 2 Oct 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 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 determine the frequency, pattern, and predictors of liver function test abnormalities among children and adolescents with type 1 diabetes mellitus attending Assiut University Children Hospital.
Detailed description
Type 1 diabetes mellitus is associated with hepatic involvement, including glycogenic hepatopathy and metabolic dysfunction-associated steatotic liver disease. Liver function test abnormalities are reported in a significant proportion of pediatric patients with type 1 diabetes, yet data from Egypt remain limited.
This cross-sectional study will include children and adolescents aged 1 to 18 years with confirmed type 1 diabetes mellitus on insulin therapy. Clinical data, anthropometric measurements, and laboratory investigations including liver function tests will be collected. The study will determine the frequency and patterns of LFT abnormalities and identify independent clinical and biochemical predictors.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Children and adolescents with type 1 diabetes mellitus | – | –Children and adolescents aged 1-18 years with confirmed type 1 diabetes mellitus on insulin therapy who will undergo clinical assessment and laboratory evaluation of liver function tests. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged 1 to 18 years with confirmed type 1 diabetes mellitus attending the Pediatric Endocrinology and Diabetes Clinic and Pediatric Wards of Assiut University Children Hospital.
Key inclusion criteria (3 listed)
- - Age 1 to 18 years
- Confirmed type 1 diabetes mellitus on insulin therapy
- Willingness of parents/guardians to provide informed consent
Key exclusion criteria (4 listed)
- - Pre-existing chronic liver disease
- Type 2 diabetes mellitus
- Acute systemic infections
- Concurrent use of hepatotoxic medications
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
Frequency of liver function test abnormalities
Time frame: Baseline
Proportion of children and adolescents with type 1 diabetes mellitus who have abnormal liver function tests (elevated ALT, AST, GGT, ALP, or bilirubin, or decreased albumin), expressed as percentage.
3 secondary outcomes
Pattern of LFT abnormalities
Time frame: Baseline
Independent predictors of LFT abnormalities
Time frame: Baseline
Association with glycemic control
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 8 Sep 2026.
- Background: PubMed 39686311Rousseau T, Venture G, Hernandez V. Latent Space Representation of Human Movement: Assessing the Effects of Fatigue. Sensors (Basel). 2024 Dec 4;24(23):7775. doi: 10.3390/s24237775.
- Background: PubMed 29283181Martinello K, Sciaccaluga M, Morace R, Mascia A, Arcella A, Esposito V, Fucile S. Loss of constitutive functional gamma-aminobutyric acid type A-B receptor crosstalk in layer 5 pyramidal neurons of human epileptic temporal cortex. Epilepsia. 2018 Feb;59(2):449-459. doi: 10.1111/epi.13991. Epub 2017 Dec 28.
- Background: PubMed 31367158Vidal-Lletjos S, Andriamihaja M, Blais A, Grauso M, Lepage P, Davila AM, Gaudichon C, Leclerc M, Blachier F, Lan A. Mucosal healing progression after acute colitis in mice. World J Gastroenterol. 2019 Jul 21;25(27):3572-3589. doi: 10.3748/wjg.v25.i27.3572.
- Background: PubMed 23153303Sanyal U, Jagirdar BR. Metal and alloy nanoparticles by amine-borane reduction of metal salts by solid-phase synthesis: atom economy and green process. Inorg Chem. 2012 Dec 3;51(23):13023-33. doi: 10.1021/ic3021436. Epub 2012 Nov 15.
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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.
Kotb A Metwalley, prof study chair
pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Liver Diseases, 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 3 inclusion and 4 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 8 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 Hager R Mahmoud, Resident (+20 11 16532651, hagar.18313535@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of liver function test abnormalities (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07807553, which also lists 4 linked publications.
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 8 Sep 2026.