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COMPLETED
NCT07627230

Biomarkers of Type 1 Diabetes in Children and Their Healthy Siblings

Sponsor: Privolzhsky Research Medical University

View on ClinicalTrials.gov

Summary

This prospective observational cohort study evaluated genetic, immunologic, and environmental factors associated with type 1 diabetes in children. Children with newly diagnosed type 1 diabetes and their healthy siblings were enrolled between October 2017 and June 2021. Data collection included HLA class I and class II genotyping, measurement of diabetes-associated autoantibodies to insulin (IAA), glutamic acid decarboxylase (GADA), insulinoma-associated antigen-2 (IA-2A), zinc transporter 8 (ZnT8A), and islet cell antibodies (ICA), as well as C-peptide and glycated hemoglobin (HbA1c). Healthy siblings underwent annual follow-up assessments for three years, while children with type 1 diabetes were evaluated every three months during the first year after diagnosis. Information on environmental risk factors was collected using an investigator-developed questionnaire based on anamnestic data. The study aimed to identify biomarkers and risk factors associated with the development and progression of type 1 diabetes in children.

Official title: Prospective Cohort Study of Genetic, Immunologic, and Environmental Risk Factors for Type 1 Diabetes in Children and Their Healthy Siblings

Key Details

Gender

All

Age Range

4 Months - 29 Years

Study Type

OBSERVATIONAL

Enrollment

1034

Start Date

2017-10-25

Completion Date

2026-01-25

Last Updated

2026-06-04

Healthy Volunteers

Yes

Locations (1)

Privolzhsky Research Medical University

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia