ClinicalTrials.gg
Not yet recruitingNCT07807553Updated Sep 8, 2026

Liver Function Test Abnormalities in Pediatric Type 1 Diabetes

An observational study in Diabetes Mellitus, Type 1 and Liver Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
101
Ages
1 Year to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Diabetes Mellitus, Type 1 by Assiut University — 7 open to participants now, 7 under way, none of them phase 3. Diabetes Mellitus, Type 1 · Assiut University.

Planned enrollment
7th of 10
101 · median 115
Started
2026
with 2 others
Observational
10 of 11
6 open now
Registered
10th of 11
by date

Among the 11 studies in Diabetes Mellitus, Type 1 by Assiut University, this one is the 7th largest by planned enrollment of the 10 observational ones, is one of 3 that started in 2026, is one of 10 observational ones, and was the 10th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

Observationalthis study10 · 6 open
Phase 11 · 1 open

By the year they started

First in 2017; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 100 across the 1 interventional studies, 115 across the 10 observational. None of them has completed or been terminated yet.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Diabetes Mellitus, Type 1 by Assiut University, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Diabetes Mellitus, Type 1
  • Liver Diseases

Keywords

  • Type 1 diabetes mellitus
  • Liver function tests
  • Adolescents
  • Children
  • Predictors
04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • - Pre-existing chronic liver disease
  • Type 2 diabetes mellitus
  • Acute systemic infections
  • Concurrent use of hepatotoxic medications
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
101 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

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: Baseline

Secondary outcomes

  1. Pattern of LFT abnormalities

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

    Time frame: Baseline

  2. Independent predictors of LFT abnormalities

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

    Time frame: Baseline

  3. Association with glycemic control

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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 39686311 ↗
  • 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. PubMed 29283181 ↗
  • 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. PubMed 31367158 ↗
  • 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. PubMed 23153303 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Oct 2027, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 8, 2026
StartEst.
Sep 2, 2026
Primary completionEst.
Oct 2, 2027
CompletionEst.
Jun 1, 2028
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07807553
Lead sponsor
Assiut University
Responsible party
Hager Raey Heshmat Mahmoud (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 8, 2026
Start date
Sep 2, 2026 (estimated)
Primary completion
Oct 2, 2027 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Hager R Mahmoud, Resident
Contact
hagar.18313535@med.aun.edu.eg
+20 11 16532651
Kotb A Metwalley, prof
study chair · pediatrics Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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