Abstract
Background:Diabetes is a complex, multi-symptomatic disease whose complications drives increases in healthcare costs as the diabetes prevalence grows rapidly world-wide. Real-world electronic health records (EHRs) coupled with patient biospecimens, biological understanding, and technologies can characterize emerging diagnostic autoimmune markers resulting from proteomic discoveries.Methods:Circulating autoantibodies for C-terminal fragments of adiponectin receptor 1 (IgG-CTF) were measured by immunoassay to establish the reference range using midpoint samples from 1862 participants in a 20-year observational study of type 2 diabetes and cardiovascular arterial disease (CVAD) conducted by the Fairbanks Institute. The White Blood Cell elastase activity in these patients was assessed using immunoassays for Bikunin and Uristatin. Participants were assigned to four cohorts (healthy, T2D, CV, CV+T2D) based on analysis of their EHRs and the diagnostic biomarkers values and patient status were assessed ten-years post-sample.Results:The IgG-CTF reference range was determined to be 75–821 ng/mL and IgG-CTF out-of-range values did not predict cohort or comorbidity as determined from the EHRs at 10 years after sample collection nor did IgG-CTF demonstrate a significant risk for comorbidity or death. Many patients at sample collection time had other conditions (hypertension, hyperlipidemia, or other risk factors) of which only hypertension, Uristatin and Bikunin values correlated with increased risk of developing additional comorbidities (odds ratio 2.58–13.11, P<0.05).Conclusions:This study confirms that retrospective analysis of biorepositories coupled with EHRs can establish reference ranges for novel autoimmune diagnostic markers and provide insights into prediction of specific health outcomes and correlations to other markers.
Highlights
Diabetes is a complex, multi-symptomatic disease whose complications drives increases in healthcare costs as the diabetes prevalence grows rapidly world-wide
This study confirms that retrospective analysis of biorepositories coupled with electronic health records (EHRs) can establish reference ranges for novel autoimmune diagnostic markers and provide insights into prediction of specific health outcomes and correlations to other markers
The types of diagnostic tests used in this study agreed with the standards of care that would be expected for patients with type 2 diabetes (T2D) and cardiovascular disease (CV) over this study period
Summary
Multi-symptomatic disease whose complications drives increases in healthcare costs as the diabetes prevalence grows rapidly world-wide. CVAD has the greatest economic burden, affecting one in four American adults and accounting for 6 million hospitalizations per year as well as nearly 40% of all deaths (~17 million per year) Patients with both diabetes and CVAD exhibit significantly higher hazard ratios for additional complications than those with diabetes alone [2,3]. Insulin resistance and chronic inflammation are strongly associated with the progression of metabolic syndrome and CVAD in diabetes patients [4,5]. These are complex, multi-factorial conditions and numerous biomarkers have been proposed, but few have proven effective for patient management [5].
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