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Diabetes Metab Res Rev. 2015 Sep;31(6):588-94. doi: 10.1002/dmrr.2643. Epub 2015 Apr 23.

Heterogeneity in recent-onset type 1 diabetes - a clinical trial perspective.

Author information

1
Division of Systems Medicine, Department of Pediatrics, Stanford University, Stanford, CA, USA.
2
Pediatric Epidemiology Center, University of South Florida, Tampa, FL, USA.
3
Department of Pediatrics, Division of Endocrinology, Stanford University, Stanford, CA, USA.
4
Western Michigan University Homer Stryker MD School of Medicine, Kalamazoo, MI, USA.
5
Benaroya Research Institute, Seattle, WA, USA.

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.

KEYWORDS:

C-peptide; type 1 diabetes TrialNet; type 1 diabetes clinical trials

PMID:
25689602
PMCID:
PMC4815427
DOI:
10.1002/dmrr.2643
[Indexed for MEDLINE]
Free PMC Article

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