Type 1 Diabetes MellitusNCT07627230
Biomarkers of Type 1 Diabetes in Children and Their Healthy Siblings
An observational study of Type 1 Diabetes Mellitus, run by Privolzhsky Research Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 months to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 1,034 participants
- Where
- 1 siteRussia
- Study dates
- 25 Oct 2017to 25 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population included children with newly diagnosed type 1 diabetes mellitus and their healthy biological siblings recruited between October 2017 and June 2021. Healthy siblings had no laboratory evidence of type 1 diabetes at enrollment and were followed prospectively to assess the risk of disease development.
Who may be able to join
- 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.
Who cannot join
- Monogenic diabetes mellitus; Secondary diabetes mellitus; Refusal or withdrawal of informed consent.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Privolzhsky Research Medical University
Nizhny Novgorod, Nizhny Novgorod Oblast, 603000
About this study
Official title: Prospective Cohort Study of Genetic, Immunologic, and Environmental Risk Factors for Type 1 Diabetes in Children and Their Healthy Siblings
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.
Read the detailed description
Type 1 diabetes is a chronic autoimmune disease resulting from immune-mediated destruction of pancreatic beta cells. Genetic susceptibility, autoimmune processes, and environmental exposures are believed to contribute to disease development and progression.
This prospective observational cohort study included children with newly diagnosed type 1 diabetes and their healthy siblings. Participants were enrolled between October 2017 and June 2021. Baseline assessment 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).
Children with type 1 diabetes underwent follow-up clinical and laboratory assessments every three months during the first year after diagnosis. Healthy siblings underwent annual follow-up assessments for three years, including repeated evaluation of diabetes-associated autoantibodies, C-peptide, and glycated hemoglobin. HLA genotyping was performed only at baseline.
Parents completed an investigator-developed questionnaire designed to collect anamnestic information on environmental risk factors for type 1 diabetes identified in the scientific literature. The questionnaire included data on prenatal and perinatal history, infant feeding practices, infectious diseases, family history, and other environmental exposures potentially associated with type 1 diabetes risk.
Follow-up of healthy siblings continued until January 25, 2026, through telephone contact to determine whether type 1 diabetes had developed during the observation period. The collected data were used to evaluate associations among genetic, immunologic, laboratory, and environmental factors and to identify biomarkers associated with the risk and progression of type 1 diabetes in children.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Children Siblings HLA Genotyping Autoantibodies Islet Autoimmunity C-Peptide HbA1c Risk Factors Prospective Cohort Study
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children With Newly Diagnosed Type 1 Diabetes | Children with newly diagnosed type 1 diabetes enrolled between October 2017 and June 2021. Participants underwent HLA class I and class II genotyping, assessment of diabetes-associated autoantibodies (IAA, GADA, IA-2A, ZnT8A, and ICA), C-peptide measurement, and glycated hemoglobin (HbA1c) assessment. Follow-up clinical and laboratory evaluations were performed every three months during the first year after diagnosis. | |
| Healthy Siblings | Healthy siblings of children with type 1 diabetes enrolled between October 2017 and June 2021. Participants underwent HLA class I and class II genotyping, assessment of diabetes-associated autoantibodies (IAA, GADA, IA-2A, ZnT8A, and ICA), C-peptide measurement, and glycated hemoglobin (HbA1c) assessment. Follow-up laboratory evaluations were performed annually for three years. Long-term follow-up continued through telephone contact to determine whether type 1 diabetes developed during the observation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a Prediction Model for Type 1 Diabetes in Healthy Siblings
Development of a prediction model for type 1 diabetes based on HLA class I and class II genotypes, diabetes-associated autoantibodies (IAA, GADA, IA-2A, ZnT8A, and ICA), C-peptide, glycated hemoglobin (HbA1c), and environmental risk factors in healthy siblings of children with type 1 diabetes.
Measured: Up to January 25, 2026
Secondary outcomes (4)
Development of Type 1 Diabetes in Healthy Siblings
Occurrence of type 1 diabetes among healthy siblings during follow-up.
Measured: October 2017 to January 25, 2026
Diabetes-Associated Autoantibody Profile
Assessment of diabetes-associated autoantibodies (IAA, GADA, IA-2A, ZnT8A, and ICA) in children with type 1 diabetes and their healthy siblings.
Measured: Up to 3 years
HLA Class I and Class II Genotypes
Assessment of HLA class I and class II genotypes associated with susceptibility to type 1 diabetes.
Measured: Baseline
C-Peptide and Glycated Hemoglobin (HbA1c)
Assessment of endogenous insulin secretion and glycemic status using C-peptide and glycated hemoglobin measurements.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start25 Oct 2017
- Primary completion25 Jan 2026
- Study completion25 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Privolzhsky Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasia E. Bolshakova, Privolzhsky Research Medical University
- Investigators
- Ksenia Georgievna Korneva, MD, PhD, Principal investigator, Privolzhsky Research Medical University, Nizhny Novgorod, RussiaOlga Borisovna Bezlepkina, MD, DSc, Study chair, National Medical Research Center for Endocrinology, Moscow, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627230
- Sponsor's protocol ID
- T1D-SIB-2017
- Status last verified
- May 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korneva KG, Strongin LG, Kolbasina EV, Budylina MV, Makeeva NV, Zagainov VE. Diagnostic Capabilities of Islet Autoantibodies in Children with New-Onset Type 1 Diabetes Mellitus and Healthy Siblings. Sovrem Tekhnologii Med. 2021;12(6):29-34. doi: 10.17691/stm2020.12.6.04. Epub 2020 Dec 28.
PubMed 34796016Korneva KG, Chichevatov DA, Bezlepkina OB, Strongin LG, Zagainov VE. [Prognostic significance of dynamic evaluation of C-peptide level in prediction type 1 diabetes mellitus in children]. Probl Endokrinol (Mosk). 2026 May 20;72(2):78-85. doi: 10.14341/probl13645. Russian.
PubMed 42227094Korneva KG, Chichevatov DA, Strongin LG, Zagainov VE. Role of Dynamic Autoantibody Measurement in Predicting Type 1 Diabetes in Children. Russian Medical Journal. 2025;31(5):458-469. doi:10.17816/medjrf686278
Korneva KG, Strongin LG, Nazarova KYu, Zagainov VE. Potential Risk Factors for Type 1 Diabetes Development. Diabetes Mellitus. 2022;25(3):256-266.
Korneva KG, Strongin LG, Zagainov VE. Predictive and Immunological Markers of Type 1 Diabetes Risk. Diabetes Mellitus. 2021;24(2):167-174.
Korneva KG, Strongin LG, Almazova AM, Kolbasina EV, Budylina MV, Makeeva NV, Zagainov VE. Risk Factors for Type 1 Diabetes Manifestation in Children of the Volga Region. Endocrinology: News, Opinions, Training. 2019;8(4):7-14.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Genetic, Immunologic, and Environmental Risk Factors for Type 1 Diabetes in Children and Their Healthy Siblings
- ClinicalTrials.gov ID
- NCT07627230
- Acronym / sponsor ID
- T1D-SIB-2017
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Children Siblings HLA Genotyping Autoantibodies Islet Autoimmunity C-Peptide HbA1c Risk Factors Prospective Cohort Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- Privolzhsky Research Medical UniversityUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 1 diabetes is a chronic autoimmune disease resulting from immune-mediated destruction of pancreatic beta cells. Genetic susceptibility, autoimmune processes, and environmental exposures are believed to contribute to disease development and progression.
This prospective observational cohort study included children with newly diagnosed type 1 diabetes and their healthy siblings. Participants were enrolled between October 2017 and June 2021. Baseline assessment 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).
Children with type 1 diabetes underwent follow-up clinical and laboratory assessments every three months during the first year after diagnosis. Healthy siblings underwent annual follow-up assessments for three years, including repeated evaluation of diabetes-associated autoantibodies, C-peptide, and glycated hemoglobin. HLA genotyping was performed only at baseline.
Parents completed an investigator-developed questionnaire designed to collect anamnestic information on environmental risk factors for type 1 diabetes identified in the scientific literature. The questionnaire included data on prenatal and perinatal history, infant feeding practices, infectious diseases, family history, and other environmental exposures potentially associated with type 1 diabetes risk.
Follow-up of healthy siblings continued until January 25, 2026, through telephone contact to determine whether type 1 diabetes had developed during the observation period. The collected data were used to evaluate associations among genetic, immunologic, laboratory, and environmental factors and to identify biomarkers associated with the risk and progression of type 1 diabetes in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children With Newly Diagnosed Type 1 Diabetes | – | –Children with newly diagnosed type 1 diabetes enrolled between October 2017 and June 2021. Participants underwent HLA class I and class II genotyping, assessment of diabetes-associated autoantibodies (IAA, GADA, IA-2A, ZnT8A, and ICA), C-peptide measurement, and glycated hemoglobin (HbA1c) assessment. Follow-up clinical and laboratory evaluations were performed every three months during the first year after diagnosis. |
| Healthy Siblings | – | –Healthy siblings of children with type 1 diabetes enrolled between October 2017 and June 2021. Participants underwent HLA class I and class II genotyping, assessment of diabetes-associated autoantibodies (IAA, GADA, IA-2A, ZnT8A, and ICA), C-peptide measurement, and glycated hemoglobin (HbA1c) assessment. Follow-up laboratory evaluations were performed annually for three years. Long-term follow-up continued through telephone contact to determine whether type 1 diabetes developed during the observation period. |
Who may qualify
- Ages
- 4 months to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population included children with newly diagnosed type 1 diabetes mellitus and their healthy biological siblings recruited between October 2017 and June 2021. Healthy siblings had no laboratory evidence of type 1 diabetes at enrollment and were followed prospectively to assess the risk of disease development.
Key inclusion criteria (6 listed)
- 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.
- 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.
- Written informed consent obtained from parents or legal guardians prior to study enrollment.
Key exclusion criteria (1 listed)
- Monogenic diabetes mellitus; Secondary diabetes mellitus; Refusal or withdrawal of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of a Prediction Model for Type 1 Diabetes in Healthy Siblings
Time frame: Up to January 25, 2026
Development of a prediction model for type 1 diabetes based on HLA class I and class II genotypes, diabetes-associated autoantibodies (IAA, GADA, IA-2A, ZnT8A, and ICA), C-peptide, glycated hemoglobin (HbA1c), and environmental risk factors in healthy siblings of children with type 1 diabetes.
4 secondary outcomes
Development of Type 1 Diabetes in Healthy Siblings
Time frame: October 2017 to January 25, 2026
Diabetes-Associated Autoantibody Profile
Time frame: Up to 3 years
HLA Class I and Class II Genotypes
Time frame: Baseline
C-Peptide and Glycated Hemoglobin (HbA1c)
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Results publication: PubMed 34796016Korneva KG, Strongin LG, Kolbasina EV, Budylina MV, Makeeva NV, Zagainov VE. Diagnostic Capabilities of Islet Autoantibodies in Children with New-Onset Type 1 Diabetes Mellitus and Healthy Siblings. Sovrem Tekhnologii Med. 2021;12(6):29-34. doi: 10.17691/stm2020.12.6.04. Epub 2020 Dec 28.
- Results publication: PubMed 42227094Korneva KG, Chichevatov DA, Bezlepkina OB, Strongin LG, Zagainov VE. [Prognostic significance of dynamic evaluation of C-peptide level in prediction type 1 diabetes mellitus in children]. Probl Endokrinol (Mosk). 2026 May 20;72(2):78-85. doi: 10.14341/probl13645. Russian.
- Results publicationKorneva KG, Chichevatov DA, Strongin LG, Zagainov VE. Role of Dynamic Autoantibody Measurement in Predicting Type 1 Diabetes in Children. Russian Medical Journal. 2025;31(5):458-469. doi:10.17816/medjrf686278
- Results publicationKorneva KG, Strongin LG, Nazarova KYu, Zagainov VE. Potential Risk Factors for Type 1 Diabetes Development. Diabetes Mellitus. 2022;25(3):256-266.
- Results publicationKorneva KG, Strongin LG, Zagainov VE. Predictive and Immunological Markers of Type 1 Diabetes Risk. Diabetes Mellitus. 2021;24(2):167-174.
- Results publicationKorneva KG, Strongin LG, Almazova AM, Kolbasina EV, Budylina MV, Makeeva NV, Zagainov VE. Risk Factors for Type 1 Diabetes Manifestation in Children of the Volga Region. Endocrinology: News, Opinions, Training. 2019;8(4):7-14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ksenia Georgievna Korneva, MD, PhD principal investigator
Privolzhsky Research Medical University, Nizhny Novgorod, Russia
Olga Borisovna Bezlepkina, MD, DSc study chair
National Medical Research Center for Endocrinology, Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Privolzhsky Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a Prediction Model for Type 1 Diabetes in Healthy Siblings (time frame: Up to January 25, 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07627230, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.