Investigating Genetic Risk for Type 1 Diabetes (INGR1D)
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ClinicalTrials.gov Identifier: NCT03503747 |
Recruitment Status :
Recruiting
First Posted : April 20, 2018
Last Update Posted : May 15, 2018
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Condition or disease |
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Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
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 |
Estimated Enrollment : | 30000 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Investigating Genetic Risk for Type 1 Diabetes |
Actual Study Start Date : | April 25, 2018 |
Estimated Primary Completion Date : | February 2021 |
Estimated Study Completion Date : | February 2021 |

- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 4 Months (Child) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503747
United Kingdom | |
Oxford University Hospitals NHS Trust | Recruiting |
Oxford, United Kingdom | |
Contact: Manu Vatish, PhD 01865 221009 manu.vatish@obs-gyn.ox.ac.uk |
Additional Information:
Responsible Party: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT03503747 History of Changes |
Other Study ID Numbers: |
OVG 2017/09 |
First Posted: | April 20, 2018 Key Record Dates |
Last Update Posted: | May 15, 2018 |
Last Verified: | May 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
type 1 diabetes Infants INGR1D |
Diabetes Mellitus Diabetes Mellitus, Type 1 Metabolic Diseases Glucose Metabolism Disorders |
Autoimmune Diseases Immune System Diseases Endocrine System Diseases |