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Heterogeneity in recent‐onset type 1 diabetes – a clinical trial perspective
Author(s) -
Bollyky Jennifer B.,
Xu Ping,
Butte Atul J.,
Wilson Darrell M.,
Beam Craig A.,
Greenbaum Carla J.
Publication year - 2015
Publication title -
diabetes/metabolism research and reviews
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.307
H-Index - 110
eISSN - 1520-7560
pISSN - 1520-7552
DOI - 10.1002/dmrr.2643
Subject(s) - medicine , national health and nutrition examination survey , type 1 diabetes , overweight , cohort , population , body mass index , diabetes mellitus , clinical trial , pediatrics , gerontology , endocrinology , environmental health
Background Type 1 diabetes (T1D) TrialNet is a National Institutes of Health‐sponsored clinical trial network aimed at altering the disease course of T1D. The purpose of this study is to evaluate age‐dependent heterogeneity in clinical, metabolic and immunologic characteristics of individuals with recent‐onset T1D, to identify cohorts of interest and to aid in planning of future studies. Methods Eight hundred eighty‐three individuals with recent‐onset T1D involved in five TrialNet studies were categorized by age as follows: ≥18 years, 12–17 years, 8–12 years and <8 years. Data were compared with healthy age‐matched subjects in the National Health and Nutrition Examination Survey. Results Only 2.0% of the individuals overall were excluded from trial participation because of insufficient C‐peptide values (<0.2 pmol/mL). A disproportionate number of these subjects were <8 years old. Leukopenia was present in 21.2% of individuals and lymphopenia in 11.6%; these frequencies were markedly higher than age‐matched healthy National Health and Nutrition Examination Survey population. Of the cohort, 24.5% were overweight or obese. Neither high‐risk human leukocyte antigen type DR3 nor DR4 was present in 31% of adults and 21% of children. Conclusions The ability of recent‐onset T1D patients to meet key entry criteria for TrialNet studies, including C‐peptide >0.2 pmol/mL, varies by age. Lower C‐peptide level requirements for younger participants and other aspects of heterogeneity of recent‐onset T1D patients, such as white blood cell count abnormalities and body mass index should be considered in the design of future clinical studies. Copyright © 2015 John Wiley & Sons, Ltd.