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NCT Number: NCT07807553

Liver Function Test Abnormalities in Pediatric Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pattern of LFT abnormalities

    Time frame: Baseline

    Characterization of LFT abnormality patterns (hepatocellular, cholestatic, mixed, or synthetic dysfunction)

  2. Independent predictors of LFT abnormalities

    Time frame: Baseline

    Clinical and biochemical factors independently associated with abnormal liver function tests using multivariable logistic regression analysis.

  3. Association with glycemic control

    Time frame: Baseline

    Comparison of LFT abnormalities between patients with good and poor glycemic control based on HbA1c levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Hager R Mahmoud, Resident

CONTACT

[email protected]

+20 11 16532651

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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