Investigating Genetic Risk for Type 1 Diabetes (INGR1D)

September 23, 2021 updated by: University of Oxford
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

15640

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom
        • Oxford University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 4 months (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will include all infants where the mother has consented to the additional screening test being performed.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of the number of participants with high-risk genetic markers for the development of type 1 diabetes.
Time Frame: 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.
February 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2018

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVG 2017/09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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