Investigating Genetic Risk for Type 1 Diabetes

Diabetes Mellitus Clinical Trial

— INGR1D  

Official title:

Investigating Genetic Risk for Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503747
• Other study ID #: OVG 2017/09
• Status: Completed
• Start date: April 25, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2020
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15640
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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.

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of the number of participants with high-risk genetic markers for the development of type 1 diabetes.	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.	February 2021

External Links

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