Liver Function Test Abnormalities in Pediatric Type 1 Diabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Age 1 to 18 years
Confirmed type 1 diabetes mellitus on insulin therapy
Willingness of parents/guardians to provide informed consent
Disqualifiers
- Pre-existing chronic liver disease
Type 2 diabetes mellitus
Acute systemic infections
Concurrent use of hepatotoxic medications
Trial 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.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
101 Participants
are grouped into 1 trial groupGroup A: Single cohort: Children and adolescents with type 1 diabetes mellitus
Trial outcomes
Primary outcomes
1
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.
Time frame
BaselineSecondary outcomes
1
Pattern of LFT abnormalities
Characterization of LFT abnormality patterns (hepatocellular, cholestatic, mixed, or synthetic dysfunction)
Time frame
Baseline2
Independent predictors of LFT abnormalities
Clinical and biochemical factors independently associated with abnormal liver function tests using multivariable logistic regression analysis.
Time frame
Baseline3
Association with glycemic control
Comparison of LFT abnormalities between patients with good and poor glycemic control based on HbA1c levels.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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