1. Heterogeneity in recent-onset type 1 diabetes - a clinical trial perspective.
- Author
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Bollyky JB, Xu P, Butte AJ, Wilson DM, Beam CA, and Greenbaum CJ
- Subjects
- Adolescent, Adult, Age Factors, Autoantibodies analysis, Biomarkers blood, Body Mass Index, C-Peptide blood, Child, Cohort Studies, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 immunology, Diabetes Mellitus, Type 1 metabolism, Humans, Italy, Middle Aged, North America, Young Adult, Diabetes Mellitus, Type 1 complications, Leukopenia complications, Lymphopenia complications, Obesity complications, Overweight complications, Pediatric Obesity complications
- Abstract
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.)
- Published
- 2015
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