Infections are a major complication and contributor to the morbidity and mortality associated with hematopoietic cell transplantation (HCT);Evidence is beginning to emerge regarding the contribution of abnormal glycemic status, newly termed malglycemia (defined as hyperglycemia: blood glucose [BG] >126 mg/dL, hypoglycemia: BG <70 mg/dL, or increased glycemic variability: standard deviation >29 mg/dL), to infections and related complications among HCT recipients. Ultimately, glycemic control may contribute to infection prevention. To address this issue, the primary aims of this pilot study are to determine the correlations between glycemic status and infection rates among autologous HCT recipients at the NYU Langone Medical Center (NYUMC) and evaluate three of the potential contributors (age, body/mass index [BMI], and glucocorticoid use) to glycemic status in this patient population. A secondary aim is to determine which proinflammatory cytokine are overexpressed as the glycemic index increases in autologous HCT recipients. This will be the first prospective study of this nature. HCT recipients are a unique, homogenous group that can provide salient information regarding associations between glycemic status and infections under the stress of cancer and cancer-related treatments. In this repeated measures pilot study, 75 patients scheduled to receive autologous HCT at NYUMC will be enrolled. Daily fasting BG measurements that are part of routine laboratory testing in this patient population will be evaluated for the level, timing, and frequency of malglycemic states in comparison to infection onset. Contributors to glycemic status will be compared to variations in glycemic status between patients in the areas of age, BMI, and use of glucocorticoids. Inflammatory biomarkers will be measured on a random subsample of 25 patients. Samples will be taken just prior to the start of the conditioning regimen and then compared to samples during the neutropenic/pre- engraftment phase on days 1, 5, 9, and 14 post transplant. Serum samples (5 mL/sample) for biomarker measurements will be obtained during routine laboratory blood draws so as to not induce further risk or stress to the patient. In analyzing the data, rates or correlation coefficients will be used to describe associations between glycemic status and the development of infection, as well as to evaluate associations between age, BMI, and glucocorticoid use and glycemic status, and either X2 (or Fisher exact tests, if warranted) for discrete variables, or t-tests for continuous variables, will be used to test their significance. Correlation coefficients will also be used to evaluate associations between continuous measures of glycemic levels and proinflammatory cytokine expression. The information provided through this research is in direct alignment with the mission and strategic plan of the National Institute of Nursing Research within the key area of "integrating biological and behavioral science for better health. This research will not only benefit HCT recipients, but will translate to improved care of patients with various types of cancers and chronic conditions.

Public Health Relevance

To address the significant problem of infections in patients with cancer, the aims of this study are to determine the correlations between glycemic status and infection rates, evaluate three of the potential contributors to malglycemia, and to enhance understanding of immune function under the stress of malignancies, evaluate proinflammatory cytokine expression in comparison to glycemic status among autologous HCT recipients. Findings from this study can lead to nursing-centric interventions for better glycemic control as a novel approach to better infection control among HCT recipients and may be translatable to other populations of patients with cancer and other chronic conditions.

National Institute of Health (NIH)
National Institute of Nursing Research (NINR)
Mentored Patient-Oriented Research Career Development Award (K23)
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National Institute of Nursing Research Initial Review Group (NRRC)
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Roary, Mary
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New York University
Schools of Nursing
New York
United States
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