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

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.

Condition or disease
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases Autoimmune Diseases Immune System Diseases

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes 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.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03503747

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United Kingdom
Oxford University Hospitals NHS Trust Recruiting
Oxford, United Kingdom
Contact: Manu Vatish, PhD    01865 221009   
Sponsors and Collaborators
University of Oxford

Additional Information:
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Responsible Party: University of Oxford 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Metabolic Diseases
Glucose Metabolism Disorders
Autoimmune Diseases
Immune System Diseases
Endocrine System Diseases