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Systematic Assessment of Immune Marker Variation in Type 1 Diabetes: A Prospective Longitudinal Study.

ABSTRACT: Immune analytes have been widely tested in efforts to understand the heterogeneity of disease progression, risk, and therapeutic responses in type 1 diabetes (T1D). The future clinical utility of such analytes as biomarkers depends on their technical and biological variability, as well as their correlation with clinical outcomes. To assess the variability of a panel of 91 immune analytes, we conducted a prospective study of adults with T1D (<3 years from diagnosis), at 9-10 visits over 1 year. Autoantibodies and frequencies of T-cell, natural killer cell, and myeloid subsets were evaluated; autoreactive T-cell frequencies and function were also measured. We calculated an intraclass correlation coefficient (ICC) for each marker, which is a relative measure of between- and within-subject variability. Of the 91 analytes tested, we identified 35 with high between- and low within-subject variability, indicating their potential ability to be used to stratify subjects. We also provide extensive data regarding technical variability for 64 of the 91 analytes. To pilot the concept that ICC can be used to identify analytes that reflect biological outcomes, the association between each immune analyte and C-peptide was also evaluated using partial least squares modeling. CD8 effector memory T-cell (CD8 EM) frequency exhibited a high ICC and a positive correlation with C-peptide, which was also seen in an independent dataset of recent-onset T1D subjects. More work is needed to better understand the mechanisms underlying this relationship. Here we find that there are a limited number of technically reproducible immune analytes that also have a high ICC. We propose the use of ICC to define within- and between-subject variability and measurement of technical variability for future biomarker identification studies. Employing such a method is critical for selection of analytes to be tested in the context of future clinical trials aiming to understand heterogeneity in disease progression and response to therapy.

SUBMITTER: Speake C

PROVIDER: S-EPMC6753618 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Systematic Assessment of Immune Marker Variation in Type 1 Diabetes: A Prospective Longitudinal Study.

Speake Cate C Bahnson Henry T HT Wesley Johnna D JD Perdue Nikole N Friedrich David D Pham Minh N MN Lanxon-Cookson Erinn E Kwok William W WW Sehested Hansen Birgit B von Herrath Matthias M Greenbaum Carla J CJ

Frontiers in immunology 20190913

Immune analytes have been widely tested in efforts to understand the heterogeneity of disease progression, risk, and therapeutic responses in type 1 diabetes (T1D). The future clinical utility of such analytes as biomarkers depends on their technical and biological variability, as well as their correlation with clinical outcomes. To assess the variability of a panel of 91 immune analytes, we conducted a prospective study of adults with T1D (<3 years from diagnosis), at 9-10 visits over 1 year. A ...[more]

PMID: 31572352

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Project description:INTRODUCTION:Diabetes mellitus (DM) has had a wide-ranging impact on healthcare politics. Secondary diseases and complications caused by diabetes are relevant cost and utilisation factors in the healthcare system. For decades, diabetes self-management education (DSME) has played a major role in the treatment of patients with type 2 DM (T2DM). The aim of this training is to empower patients to actively influence their diabetes process by gaining knowledge about health-related behaviours, such as healthy nutrition and exercise, and cardiovascular risks. The aim of the project is to analyse the practice of structured diabetes education and the effects of different learning types of participants. This project focuses on the needs of socioeconomically deprived patients and aims to improve DSME for this group. This patient group has a higher prevalence of T2DM, more complications and worse therapy-relevant parameters. METHODS AND ANALYSIS:The study will be conducted as a prospective longitudinal study. Patients will be recruited in outpatient physician offices over a period of 12 months. Patients will be included if they are 18 years and older, have T2DM and are scheduled to participate in DSME for the first time. A pseudonymised, written survey with standardised questionnaires will be administered. The data will be analysed using inferential statistical methods, such as correlation analysis, regression models and variance analytical designs. ETHICS AND DISSEMINATION:The study will be carried out following the principles of the Declaration of Helsinki and good scientific standards. Ethical approval of the Ethics Review Committee of the Medical Faculty at Martin-Luther-University, Halle-Wittenberg, was obtained. All participants in the study will receive comprehensive information and will be included after written informed consent is obtained. The results will be published in international peer-reviewed journals and presented at several congresses. TRIAL REGISTRATION NUMBER:DRKS00016630.

Project description:Introduction: Beside positive effects on athlete's health, competitive sport can be linked with an increased risk of illness and injury. Because of high relative increases in training, additional physical and psychological strains, and an earlier specialization and professionalization, adolescent athletes needs an increased attention. Training can alter the immune system by inducing a temporary immunosuppression, finally developing infection symptoms. Previous studies identified Epstein Barr Virus (EBV) as potential indicator for the immune status. In addition to the identification of triggering risk factors for recurrent infections, the aim was to determine the interaction between training load, stress sense, immunological parameters, and clinical symptoms. Methods: A controlled, prospective, longitudinal study on young athletes (n = 274, mean age: 13.8 ± 1.5 yrs) was conducted between 2010 and 2014. Also 285 controls (students, who did not perform competitive sports, mean age: 14.5 ± 1.9 yrs) were recruited. Athletes were examined 3 times each year to determine the effects of stress factors (training load: training hours per week [Th/w]) on selected outcome parameters (clinical [susceptibility to infection, WURSS-21: 21-item Wisconsin Upper Respiratory Symptom Survey], immunological, psychological end points). As part of each visit, EBV serostatus and EBV-specific IgG tiers were studied longitudinally as potential immune markers. Results: Athletes (A) trained 14.9 ± 5.6 h weekly. Controls (C) showed no lower stress levels compared to athletes (p = 0.387). Twelve percent of athletes reported recurrent infections (C: 8.5%, p = 0.153), the presence of an upper respiratory tract infection (URTI) was achieved in 30.7%. EBV seroprevalence of athletes was 60.3% (C: 56.6%, p = 0.339). Mean EBV-specific IgG titer of athletes was 166 ± 115 U/ml (C: 137 ± 112 U/ml, p = 0.030). With increasing Th/w, higher stress levels were observed (p < 0.001). Analyzes of WURSS-21 data revealed no relationship to training load (p = 0.323). Also, training load had no relation to EBV serostatus (p = 0.057) or the level of EBV-specific IgG titers (p = 0.364). Discussion: Young elite athletes showed no increased sense of stress, no higher prevalence of recurrent infections, and no different EBV-specific serological parameters compared to controls. Also, no direct relationship between training loads, clinical complaints, and EBV-specific immune responses was found. With increasing training loads athletes felt more stressed, but significant associations to EBV-specific serological parameters were absent. In summary, EBV serostatus and EBV-specific IgG titers do not allow risk stratification for impaired health. Further investigations are needed to identify additional risk factors and immune markers, with the aim to avoid inappropriate strains by early detection and following intervention.

Dataset Information

Systematic Assessment of Immune Marker Variation in Type 1 Diabetes: A Prospective Longitudinal Study.

Publications

Systematic Assessment of Immune Marker Variation in Type 1 Diabetes: A Prospective Longitudinal Study.

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