Monocyte Soluble Activation Markers sCD14 and sCD163 in Children With Type 1 Diabetes Mellitus
1 other identifier
observational
90
0 countries
N/A
Brief Summary
The study aims to compare serum levels of sCD14 and sCD163 in children with type 1 Diabetes Mellitus with healthy controls, study the distribution of monocyte subsets in children with T1DM , correlate monocyte subsets and their soluble activation markers sCD14 and sCD163 with parameters reflecting islet β-cell insufficiency in children with T1DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
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
First Submitted
Initial submission to the registry
April 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedApril 26, 2022
April 1, 2022
1 year
April 21, 2022
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the levels of monocyte soluble activation markers among children with T1DM and healthy controls
To compare the levels of sCD14 and sCD163 among children with T1DM and healthy controls using ELISA
Baseline
Study Arms (2)
Children diagnosed to have T1DM with a minimum duration of five years
Healthy children
Interventions
Determination of serum levels of sCD14 and sCD163 using ELISA
Eligibility Criteria
Children with type 1 Diabetes Mellitus Pediatric Endocrinology Unit in Assiut University Children Hospital
You may qualify if:
- Children of any age and sex diagnosed with T1DM (according to WHO criteria) with a minimum duration of five years will be included.
You may not qualify if:
- Children with other with coexisting autoimmune, chronic, and acute inflammatory diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (11)
Ismail NA, Abd El Baky AN, Ragab S, Hamed M, Hashish MA, Shehata A. Monocyte chemoattractant protein 1 and macrophage migration inhibitory factor in children with type 1 diabetes. J Pediatr Endocrinol Metab. 2016 Jun 1;29(6):641-5. doi: 10.1515/jpem-2015-0340.
PMID: 27054595BACKGROUNDMorgan NG, Leete P, Foulis AK, Richardson SJ. Islet inflammation in human type 1 diabetes mellitus. IUBMB Life. 2014 Nov;66(11):723-34. doi: 10.1002/iub.1330. Epub 2014 Dec 11.
PMID: 25504835BACKGROUNDKim TK, Lee MS. Innate immune receptors in type 1 diabetes: the relationship to cell death-associated inflammation. Biochem Soc Trans. 2020 Jun 30;48(3):1213-1225. doi: 10.1042/BST20200131.
PMID: 32510139BACKGROUNDMarshak-Rothstein A. Autoimmunity--promoting and stabilizing innate immunity 'UNWUCHT'. Immunol Rev. 2016 Jan;269(1):7-10. doi: 10.1111/imr.12387. No abstract available.
PMID: 26683141BACKGROUNDMysliwska J, Smardzewski M, Marek-Trzonkowska N, Mysliwiec M, Raczynska K. Expansion of CD14+CD16+ monocytes producing TNF-alpha in complication-free diabetes type 1 juvenile onset patients. Cytokine. 2012 Oct;60(1):309-17. doi: 10.1016/j.cyto.2012.03.010. Epub 2012 Apr 7.
PMID: 22484242BACKGROUNDAncuta P, Weiss L, Haeffner-Cavaillon N. CD14+CD16++ cells derived in vitro from peripheral blood monocytes exhibit phenotypic and functional dendritic cell-like characteristics. Eur J Immunol. 2000 Jul;30(7):1872-83. doi: 10.1002/1521-4141(200007)30:73.0.CO;2-2.
PMID: 10940876BACKGROUNDWong KL, Tai JJ, Wong WC, Han H, Sem X, Yeap WH, Kourilsky P, Wong SC. Gene expression profiling reveals the defining features of the classical, intermediate, and nonclassical human monocyte subsets. Blood. 2011 Aug 4;118(5):e16-31. doi: 10.1182/blood-2010-12-326355. Epub 2011 Jun 7.
PMID: 21653326BACKGROUNDHarms RZ, Ostlund KR, Cabrera MS, Edwards E, Fisher M, Sarvetnick N. Confirmation and Identification of Biomarkers Implicating Environmental Triggers in the Pathogenesis of Type 1 Diabetes. Front Immunol. 2020 Sep 15;11:1922. doi: 10.3389/fimmu.2020.01922. eCollection 2020.
PMID: 33042112BACKGROUNDLaursen TL, Wong GL, Kazankov K, Sandahl T, Moller HJ, Hamilton-Dutoit S, George J, Chan HL, Gronbaek H. Soluble CD163 and mannose receptor associate with chronic hepatitis B activity and fibrosis and decline with treatment. J Gastroenterol Hepatol. 2018 Feb;33(2):484-491. doi: 10.1111/jgh.13849.
PMID: 28618015BACKGROUNDLlaurado G, Gonzalez-Clemente JM, Maymo-Masip E, Subias D, Vendrell J, Chacon MR. Serum levels of TWEAK and scavenger receptor CD163 in type 1 diabetes mellitus: relationship with cardiovascular risk factors. a case-control study. PLoS One. 2012;7(8):e43919. doi: 10.1371/journal.pone.0043919. Epub 2012 Aug 24.
PMID: 22937125BACKGROUNDRatajczak W, Atkinson SD, Kelly C. The TWEAK/Fn14/CD163 axis-implications for metabolic disease. Rev Endocr Metab Disord. 2022 Jun;23(3):449-462. doi: 10.1007/s11154-021-09688-4. Epub 2021 Sep 20.
PMID: 34542797BACKGROUND
Related Links
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
April 21, 2022
First Posted
April 26, 2022
Study Start
July 1, 2022
Primary Completion
July 1, 2023
Study Completion
August 1, 2023
Last Updated
April 26, 2022
Record last verified: 2022-04