Monocyte Soluble Activation Markers sCD14 & sCD163 in Children With Type 1

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Type 1 diabetes mellitus (T1DM) is T-cell mediated autoimmune disease in which the function of insulin-secreting pancreatic β-cells is impaired due to autoreactive immune cell-mediated destruction (insulitis). Although adaptive immunity has always been the focus for scientists in studying the pathogenesis of T1DM, yet, innate immunity also plays a critical role. Alterations in innate immune responses drive autoimmune pathogenesis, with involvement in the initial break in tolerance and the later failure of regulation. Several studies suggest that the development of T1DM is strongly associated with different immune cells, including monocytes. Specifically, an increase in the monocyte population has been shown to trigger β-cell destruction during insulitis. Intermediate monocytes may serve as M2 macrophage precursors with high anti-inflammatory properties, producing IL-10. However, other studies reported them to have an antigen-presenting function with a dendritic cell-like feature. Upon antigen stimulation, they became the main producers of inflammatory factors, like TNF-α which has been shown to correlate with the severity of T1DM. Activation of circulating monocytes to a pro-inflammatory state induces the shedding of membrane bound CD14 (mCD14) to soluble CD14. Compared to other acute phase proteins, sCD14 was found to be the most sensitive in T1DM. Soluble CD163 is present in blood serum as a result of shedding the CD163 membrane form of activated monocyte-macrophage-lineage cells in the course of inflammation. Plasma sCD163 is widely used as an immunomodulator with anti-inflammatory properties. It was found to be increased in T2DM. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05347836
Study type	Observational
Source	Assiut University
Contact	Nada M Mokhtar, MD
Phone	+201501149921
Email	nadamaher94@aun.edu.eg
Status	Not yet recruiting
Phase
Start date	July 1, 2022
Completion date	August 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03886974` - Transition to Adult Care in Type 1 Diabetes
Completed	`NCT05620251` - Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes
Completed	`NCT03623113` - The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes	N/A
Active, not recruiting	`NCT05078658` - Low-carbohydrate Diet in Children With Type 1 Diabetes	N/A
Not yet recruiting	`NCT06018324` - CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
Withdrawn	`NCT03736083` - Introducing CGM at Type 1 Diabetes Diagnosis	N/A
Completed	`NCT03177096` - Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes	N/A
Not yet recruiting	`NCT06418269` - The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes	N/A
Completed	`NCT04172077` - Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
Recruiting	`NCT04950634` - Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Completed	`NCT04450745` - Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients	N/A
Completed	`NCT03165786` - A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes	N/A
Terminated	`NCT04028960` - IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase	Phase 2
Recruiting	`NCT05324488` - Diabetes Registry Graz for Biomarker Research
Completed	`NCT02984709` - Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes	N/A
Completed	`NCT02984514` - Brown Adipose Tissue in Type 1 Diabetes	N/A
Recruiting	`NCT06372392` - Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps	N/A
Recruiting	`NCT05973799` - Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes	N/A
Recruiting	`NCT03311516` - New Insulin Therapy by Multiwave Bolus	N/A
Completed	`NCT03711656` - Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Monocyte Soluble Activation Markers sCD14 and sCD163 in Children With Type 1 Diabetes Mellitus

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms