학술논문

Biomarker discovery study design for type 1 diabetes in The Environmental Determinants of Diabetes in the Young (TEDDY) study
Document Type
article
Source
Diabetes/Metabolism Research and Reviews. 30(5)
Subject
Autoimmune Disease
Diabetes
Nutrition
Pediatric
Metabolic and endocrine
Autoantibodies
Biomarkers
Case-Control Studies
Diabetes Mellitus
Type 1
Diet
Epidemiologic Methods
Gene Expression
Humans
Islets of Langerhans
Metabolomics
Metagenomics
Microbiota
TEDDY study group
TEDDY
batch effects
biomarker discovery
nested case-control design
type 1 diabetes
Clinical Sciences
Endocrinology & Metabolism
Language
Abstract
AimsThe Environmental Determinants of Diabetes in the Young planned biomarker discovery studies on longitudinal samples for persistent confirmed islet cell autoantibodies and type 1 diabetes using dietary biomarkers, metabolomics, microbiome/viral metagenomics and gene expression.MethodsThis article describes the details of planning The Environmental Determinants of Diabetes in the Young biomarker discovery studies using a nested case-control design that was chosen as an alternative to the full cohort analysis. In the frame of a nested case-control design, it guides the choice of matching factors, selection of controls, preparation of external quality control samples and reduction of batch effects along with proper sample allocation.Results and conclusionOur design is to reduce potential bias and retain study power while reducing the costs by limiting the numbers of samples requiring laboratory analyses. It also covers two primary end points (the occurrence of diabetes-related autoantibodies and the diagnosis of type 1 diabetes). The resulting list of case-control matched samples for each laboratory was augmented with external quality control samples.