Trials / Completed

CompletedNCT03503747

Investigating Genetic Risk for Type 1 Diabetes

Status: Completed
Phase: —
Study type: Observational
Enrollment: 15,640 (actual)

Sponsor: University of Oxford · Academic / Other
Sex: All
Age: 0 Months – 4 Months
Healthy volunteers: —

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.

Conditions

Timeline

Start date: 2018-04-25
Primary completion: 2021-08-31
Completion: 2021-08-31
First posted: 2018-04-20
Last updated: 2021-09-24

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03503747. Inclusion in this directory is not an endorsement.