Liver Function Test Abnormalities in Pediatric Type 1 Diabetes

Frequency, Pattern and Predictors of Liver Function Test Abnormalities in Children and Adolescents With Type 1 Diabetes Mellitus

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07807553

Enrollment

101

Registered

2026-09-08

Start date

2026-09-02

Completion date

2028-06-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Liver Diseases

Keywords

Type 1 diabetes mellitus, Liver function tests, Adolescents, Children, Predictors

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Frequency of liver function test abnormalities	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.

Secondary

Measure	Time frame	Description
Pattern of LFT abnormalities	Baseline	Characterization of LFT abnormality patterns (hepatocellular, cholestatic, mixed, or synthetic dysfunction)
Independent predictors of LFT abnormalities	Baseline	Clinical and biochemical factors independently associated with abnormal liver function tests using multivariable logistic regression analysis.
Association with glycemic control	Baseline	Comparison of LFT abnormalities between patients with good and poor glycemic control based on HbA1c levels.

Contacts

CONTACTHager R Mahmoud, Resident

hagar.18313535@med.aun.edu.eg+20 11 16532651

STUDY_CHAIRKotb A Metwalley, prof

pediatrics Department, Assiut University Hospitals

Outcome results