NCT07627230Completed
Biomarkers of Type 1 Diabetes in Children and Their Healthy Siblings
Prospective Cohort Study of Genetic, Immunologic, and Environmental Risk Factors for Type 1 Diabetes in Children and Their Healthy Siblings
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1034 (actual)
- First submitted
- 30 May 2026
- Start date
- 25 Oct 2017
- Primary completion date
- 25 Jan 2026
- Lead sponsor
- Privolzhsky Research Medical University
- Diseases
- Type 1 diabetes
- NCT number
- NCT07627230
What you commit to
- Study type: Observational
- Participants enrolled: 1034
- From 25 Oct 2017 to the primary completion date, 25 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Monogenic diabetes mellitus; Secondary diabetes mellitus; Refusal or withdrawal of informed consent.
Who the study is looking for
- For children with newly diagnosed type 1 diabetes:
- Age 0 to 17 years, inclusive; Diagnosis of type 1 diabetes mellitus established according to World Health Organization (WHO) diagnostic criteria applicable during the study period.
- For healthy siblings:
- Biological brothers or sisters of a participant with type 1 diabetes mellitus; Absence of laboratory criteria for type 1 diabetes at enrollment, including blood glucose and glycated hemoglobin (HbA1c) values below diagnostic thresholds for type 1 diabetes.
- For all participants:
- Written informed consent obtained from parents or legal guardians prior to study enrollment.
Age in the registry: 4 months to 29 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Privolzhsky Research Medical University Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.