Investigating Genetic Risk for Type 1 Diabetes (INGR1D)

• ClinicalTrials.gov Identifier: NCT03503747
• Recruitment Status: Recruiting
• First Posted: April 20, 2018
• Last Update Posted: May 15, 2018
• Sponsor: University of Oxford
• Information provided by (Responsible Party): University of Oxford

Tracking Information

• First Submitted Date: January 30, 2018
• First Posted Date: April 20, 2018
• Last Update Posted Date: May 15, 2018
• Actual Study Start Date: April 25, 2018
• Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 19, 2018)

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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03503747 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigating Genetic Risk for Type 1 Diabetes
• Official Title: Investigating Genetic Risk for Type 1 Diabetes
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: The study will include all infants where the mother has consented to the additional screening test being performed.

Condition

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

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 19, 2018): 30000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2021
• Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 4 Months (Child)
• Accepts Healthy Volunteers: Not Provided
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03503747
• Other Study ID Numbers: OVG 2017/09
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: University of Oxford
• Study Sponsor: University of Oxford
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Oxford
• Verification Date: May 2018