Investigating Genetic Risk for Type 1 Diabetes (INGR1D)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03503747|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : May 15, 2018
|Condition or disease|
|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|
|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.
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
|Oxford University Hospitals NHS Trust||Recruiting|
|Oxford, United Kingdom|
|Contact: Manu Vatish, PhD 01865 221009 email@example.com|