Genetically Informed Screening for Early-Stage Type 1 Diabetes
ConditionDiabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-79
SponsorMassachusetts General Hospital
About this trial
This study is a test to find out if genetic information can be used to help healthcare providers identify diseases. Specifically, the investigators want to find out how genetic information can help healthcare providers identify people who may benefit from early screening for type 1 diabetes, even before people feel sick. This study aims to guide future research to improve screening, prevent disease, slow progression, and expand treatment options for type 1 diabetes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18-79 years who had participated in the Mass General Brigham (MGB) Biobank and agreed to be recontacted for future study
Disqualifiers
Individuals with current or prior treatment with immune checkpoint inhibitors (e.g., PD-1, PD-L1, or CTLA-4 inhibitors), as well as individuals with diabetes secondary to pancreatic disease, including pancreatic cancer, pancreatitis, pancreatic surgery/pancreatectomy, cystic fibrosis, or hemochromatosis
Trial population
Adults aged 18-79 years who had participated in the Mass General Brigham (MGB) Biobank and agreed to be recontacted for future study
Trial design
Design model
Ecologic or community
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Comparisons between high genetic risk vs. the rest of the cohort
The distribution of clinical features between the top 2.5% of the T1D polygenic score and the remainder of the MGB Biobank will be compared, and within the high genetic-risk stratum, between autoantibody-positive and autoantibody-negative participants. Analyses will summarize standardized differences and use logistic regression for autoantibody positivity (primary outcome), adjusted for age, sex, and ancestry PCs. To prioritize features for future recall-by-genotype enrichment, the investigators will quantify incremental discrimination (ΔAUC), partial R², and likelihood-ratio tests. Missing covariates will be mitigated via brief surveys and multiple imputation.
Time frame
12 monthsLocations
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: