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Biomarkers of Type 1 Diabetes in Children and Their Healthy Siblings

NCT07627230 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1034

Last updated 2026-06-04

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Privolzhsky Research Medical University

    lead OTHER

Principal Investigators

  • Ksenia Georgievna Korneva, MD, PhD · Privolzhsky Research Medical University, Nizhny Novgorod, Russia

  • Olga Borisovna Bezlepkina, MD, DSc · National Medical Research Center for Endocrinology, Moscow, Russia

Eligibility

Min Age
4 Months
Max Age
29 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2026-01-25
Completion
2026-01-25

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07627230 on ClinicalTrials.gov