The TrialNet Natural History Study of the Development of Type 1 Diabetes:objectives, design, and initial results

J Mahon, J Sosenko, L Rafkin-Mervis, H Krause-Steinrauf, J lachin, C Thompson, PJ Bingley, E Bonifacio, J Palmer, G Eisenbarth, J Wolfsdorf, J Skyler

Research output: Contribution to journalArticle (Academic Journal)peer-review

116 Citations (Scopus)

Abstract

ABSTRACT Objectives: TrialNet's goal to test preventions for type 1 diabetes has created an opportunity to gain new insights into the natural history of pre-type 1 diabetes. The TrialNet Natural History Study (NHS) will assess the predictive value of existing and novel risk markers for type 1 diabetes and will find subjects for prevention trials. Research design and methods: The NHS is a three-phase, prospective cohort study. In phase 1 (screening), pancreatic autoantibodies (glutamic acid decarboxylase, insulin, ICA-512, and islet cell antibodies) are measured. Phase 2 (baseline risk assessment) includes oral glucose tolerance tests (OGTTs) in antibody-positive subjects and estimation of 5-yr diabetes risks according to the OGTT and number of confirmed positive antibody tests. Phase 3 (follow-up risk assessments) requires OGTTs every 6 months. In phases 2 and 3, samples are collected for future tests of T-lymphocyte function, autoantibody isotypes, RNA gene expression, and proteomics. The primary outcome is diabetes onset. Results: Of 12 636 relatives screened between March 2004 and December 2006, 605 (4.8%) were positive for at least one biochemical antibody. Of these, 322 were confirmed antibody positive and completed phase 2, of whom 296 subjects were given preliminary 5-yr diabetes risks of
Translated title of the contributionThe TrialNet Natural History Study of the Development of Type 1 Diabetes:objectives, design, and initial results
Original languageEnglish
Pages (from-to)97 - 104
Number of pages8
JournalPediatric Diabetes
Volume10(2)
DOIs
Publication statusPublished - Apr 2009

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