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Th1, Th2, Th17 Phenotype in Urea Cycle Disorders

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05706714
Collaborator
(none)
100
Enrollment
1
Location
22.8
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Infection-related hyperammonemia in patients with urea cycle disorders is an important cause of morbidity and mortality. The relationship between immune system cells and the metabolic pathways used by these cells and inborn errors of metabolism is still under investigation. Current studies are generally based on experiments in mice. Our goal was to study specific T cell subsets to understand the effects of the urea cycle on T cells.

We collected blood samples from patients with lysinuric protein intolerance and urea cycle disorders for basic immunophenotyping, lymphocyte proliferation in response to phytohemagglutinin and CDmix, and cytokine analysis involving Th1, Th2, and Th17 and compared them with age-matched healthy controls. We also examined amino acid profiles in sera and supernatants before and after stimulation with PMA-ionomycin.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Th1, Th2, Th17 Phenotype in Urea Cycle Disorders
    Actual Study Start Date :
    Apr 6, 2021
    Actual Primary Completion Date :
    Dec 13, 2022
    Anticipated Study Completion Date :
    Mar 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with urea cycle disorder
    Patients with lysinuric protein intolerance
    Healthy control

    Outcome Measures

    Primary Outcome Measures

    1. Th1, Th2, Th17 phenotype [baseline]

    Secondary Outcome Measures

    1. T cell proliferation [baseline]

    Other Outcome Measures

    1. amino acid profile changes before and after stimulation [baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 53 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Children without any chronic conditions and having normal immunoglobulins and lymphocyte subsets
    Exclusion Criteria:
    • For healthy control, children having any signs for primary immune deficiencies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University-Cerrahpasa Istanbul Turkey 34098

    Sponsors and Collaborators

    • Istanbul University - Cerrahpasa (IUC)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayca Kiykim, Associate Professor, Istanbul University - Cerrahpasa (IUC)
    ClinicalTrials.gov Identifier:
    NCT05706714
    Other Study ID Numbers:
    • IFUCD
    First Posted:
    Jan 31, 2023
    Last Update Posted:
    Jan 31, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urea Cycle Disorders, Inborn

    Study Results

    No Results Posted as of Jan 31, 2023