Liver Function Test Abnormalities in Pediatric Type 1 Diabetes
September 2, 2026 updated by: Hager Raey Heshmat Mahmoud, Assiut University
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
101
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hager R Mahmoud, Resident
- Phone Number: +20 11 16532651
- Email: hagar.18313535@med.aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- - Age 1 to 18 years
- Confirmed type 1 diabetes mellitus on insulin therapy
- Willingness of parents/guardians to provide informed consent
Exclusion Criteria:
- - Pre-existing chronic liver disease
- Type 2 diabetes mellitus
- Acute systemic infections
- Concurrent use of hepatotoxic medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pattern of LFT abnormalities
Time Frame: Baseline
|
Characterization of LFT abnormality patterns (hepatocellular, cholestatic, mixed, or synthetic dysfunction)
|
Baseline
|
|
Independent predictors of LFT abnormalities
Time Frame: Baseline
|
Clinical and biochemical factors independently associated with abnormal liver function tests using multivariable logistic regression analysis.
|
Baseline
|
|
Association with glycemic control
Time Frame: Baseline
|
Comparison of LFT abnormalities between patients with good and poor glycemic control based on HbA1c levels.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kotb A Metwalley, prof, pediatrics Department, Assiut University Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Martinello 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.
- Vidal-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.
- Sanyal 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 2, 2026
Primary Completion (Estimated)
October 2, 2027
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
September 2, 2026
First Submitted That Met QC Criteria
September 2, 2026
First Posted (Actual)
September 8, 2026
Study Record Updates
Last Update Posted (Actual)
September 8, 2026
Last Update Submitted That Met QC Criteria
September 2, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LFT-T1DM-Pediatric-Assiut-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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