NCT07807553

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Jun 2028

First Submitted

Initial submission to the registry

September 2, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Diabetes Mellitus, Type 1Liver Diseases

Keywords

Type 1 diabetes mellitusLiver function testsAdolescentsChildrenPredictors

Outcome Measures

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.

    Baseline

Secondary Outcomes (3)

  • Pattern of LFT abnormalities

    Baseline

  • Independent predictors of LFT abnormalities

    Baseline

  • Association with glycemic control

    Baseline

Study Arms (1)

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.

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • \- Age 1 to 18 years
  • Confirmed type 1 diabetes mellitus on insulin therapy
  • Willingness of parents/guardians to provide informed consent

You may not qualify if:

  • \- Pre-existing chronic liver disease
  • Type 2 diabetes mellitus
  • Acute systemic infections
  • Concurrent use of hepatotoxic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 39686311BACKGROUND

  • 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.

    PMID: 29283181BACKGROUND

  • 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.

    PMID: 31367158BACKGROUND

  • 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.

    PMID: 23153303BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Liver Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesDigestive System Diseases

Study Officials

  • Kotb A Metwalley, prof

    pediatrics Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Hager R Mahmoud, Resident

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 8, 2026

Study Start

September 2, 2026

Primary Completion (Estimated)

October 2, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

September 8, 2026

Record last verified: 2026-09