Investigating Genetic Risk for Type 1 Diabetes

Completed

• Conditions: Diabetes Mellitus; Metabolic Disease; Endocrine System Diseases; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Autoimmune Diseases; Immune System Diseases

• Registration Number: NCT03503747
• Lead Sponsor: University of Oxford

Brief Summary

The objective of this study is to determine the percentage of children with genetic markers putting them at increased risk of developing type 1 diabetes, and to offer the opportunity for these children to be enrolled into a phase II b primary prevention trial.

Detailed Description

This is a population screening study to undertake (with prospective consent) additional testing of the newborn screening blood to identify children at increased genetic risk of type 1 diabetes. This study will enrol newborn babies whose mothers have given consent to additional testing for the newborn blood screening (routinely performed when the baby is approximately 5 days old).

Women will be approached by research staff in the second or third trimester of pregnancy (≥18 weeks gestation) when attending for antenatal care. At this point, the study will be discussed with the woman and if interested a patient information sheet will be provided as well as the opportunity to ask questions. If they agree to participate, a qualified member of the research team will take written informed consent. This consent will allow a) completion of a questionnaire and b) prospective consent to use the surplus neonatal screening blood sample for genetic testing.

The punch from the blood sample will analysed for the child's risk of type 1 diabetes. If found to be at high risk (\>10%) they will be contacted by a member of the clinical study team to discuss the results and invite them to participate in a phase II prevention trial.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-20
• Study Start: 2018-04-25
• Status Verified: 2020-12
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15640

Inclusion Criteria

• Parent/guardian of participant is willing and able to give informed consent for participation in the study.
• Participant has provided blood for the newborn screening blood test, with sufficient sample remaining after routine testing.

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Exclusion Criteria

• Parent/legal guardian unwilling or unable to give written informed consent to participate in the study
• Unable to understand written or verbal English which would preclude them from understanding the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of the number of participants with high-risk genetic markers for the development of type 1 diabetes.	February 2021	The number of children with a greater than 10% (high) risk of developing type 1 diabetes will be quantified, based on risk scores derived from SNPs that show the presence of HLA DR3, HLA DR4, and HLA DQ8 alleles as well as SNPs from HLA class I and non-HLA type 1 diabetes susceptibility genes, and from HLA class II protective alleles.

Trial Locations

Locations (1)

Oxford University Hospitals NHS Trust; 🇬🇧 Oxford, United Kingdom