Research Leadership Introductions & Overview

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2 Research Leadership Introductions & Overview Robert Deininger - VP for Research Operations Steven Smith, MD Chief Scientific Officer, SVP 2

3 ORA Classes now available with CEUs! Protocol Development CEUs 1.5 hrs Informed Consent CEUs 1.5 hrs Sample Size and Statistical Power CEUs 1 hr Study Design CEUs 1 hr Biostatistics and Epidemiology CEUs 1 hr And more coming soon! 3

4 To assure that you have the current version of forms for submission to ORA, please download forms from the Forms and Template Tab in IRBNet each time you use them. Recent revisions have been made to: Conflict of interest disclosure Significant Financial Interest disclosure COI training materials and certification Research Review Application 4

5 New Face: Jennifer Green, IND Coordinator for Dr. Baumgartner. Certification: Neuroscience: Karin Donaldson passed the Certified Clinical Research Coordinator (CCRC) exam Grants: FHCI R&D received 3 grants -1 with Eagles Foundation and 2 with SBMRI internal, Bankhead Coley with collaborator at Sanford-Burnham 5

6 FHCI R&D- Papers published/accepted for publication: PLOS One Litherland et al Persistent STAT5 Phosphorylation and Epigenetic Dysregulation of GM-CSF and PGS2/COX2 Expression in Type 1 Diabetic Human Monocytes. Molecular Genetics & Metabolism Almodovar et al Genomic structure and genetic drift in C57BL/6 congenic metabolic mutant mice. The Breast Journal Decker et al Obesity and Non-Adherence Correlate with Elevated Serum Estradiol Levels in Postmenopausal Women Receiving Adjuvant Aromatase Inhibitor Therapy. 6

7 Thrombosis: Journal of Thrombosis and Hemostasis Assessment of Protein C Anticoagulant Pathway by thrombin generation assay in the presence of endothelial cells Authors: Coll E, Robles-Carrillo L, Reyes E, Francis JL and Amirkhosravi A. 7

8 Orlando Sentinel Article October 18, 2013 FHCI: Dr. David Decker Guest Columnist 8

9 LINDY M. MOORE, MS, CES Authors: Lindy M. Moore, MS, CES; Angela M. Fals, MD, FAAP; Pamela J. Jennelle, BSc; Jeanette F. Green, MSN, ARNP; Julie Pepe, PhD 9

10 Body Mass Index (BMI) is used to determine pediatric risk for overweight and obesity. Waist to Hip Ratio (WHR) is an indicator of central adiposity, and in adults is considered to be a valid assessment tool to determine risk or presence of metabolic syndrome, diabetes, and cardiovascular disease. Studies have indicated that WHR is a superior measurement tool for identifying cardiovascular risk in adults. However, there is limited evidence based research on the use of WHR with a pediatric population. We sought to examine the relationship between WHR and variables associated with metabolic syndrome. 10

11 Primary objective: To identify whether WHR was correlated with blood laboratory values for known metabolic syndrome markers including insulin, LDL, HDL, triglycerides, and total cholesterol. Secondary objective: To examine differences in WHR for subgroups based on Tanner Stage, waist circumference, acanthosis nigricans, BMI and BMI percentile. Variables: Anthropometric measures: height, weight, BMI, BMI %ile, body fat %, waist and hip circumference, WHR Laboratory tests : total cholesterol, triglycerides, high density lipoprotein, low density lipoprotein, insulin Physical exam: Tanner stage, presence of acanthosis nigricans 11

12 Setting & Design: A retrospective chart analyses was conducted on all patients enrolled in a pediatric weight management program at Florida Hospital for Children between May 2010 and May Participants: Participants included 754 adolescents with a BMI equal to or greater than the 85 th percentile for age and gender. Mean age was 11 with a range of 6-17 years. There were 452 females and 302 males. The racial breakdown was 20% African American; 35% Caucasian; 39% Hispanic, and 6% Other. There were 716 obese children (95%) with a BMI percentile 95 and 38 overweight children (5 %) with a BMI percentile between

13 Retrospective chart reviews were conducted on all patients enrolled in the program to extract the laboratory values and results of physical examination. Demographic data was extracted from questionnaires filled out by the patient and their adult caregiver. Weight clinic staff were trained and adhered to standard protocol in use of the following equipment to obtain measures: Seca stadiometer for height; Tanita bioelectrical impedance scale for weight, BMI, and body fat; loaded cloth tape measure for waist and hip circumference. The pediatric obesity medicine physician determined Tanner stage and presence or absence of acanthosis nigricans. 13

14 Correlations between WHR and Labs Correlations between WHR and BMI, body fat percentage, and waist circumference WHR and BMI percentile A one way ANOVA found a significant effect in WHR by BMI percentile, F (1, 754) = , p <.001, η 2 =.029. The subjects were restricted, as there were only overweight and obese subjects in this study. The average WHR for overweight subjects was M =.8452 (SD =.066) while the average WHR for obese subjects was M =.9007 (SD =.071). 14

15 We found that WHR was significantly correlated with laboratory markers of metabolic syndrome except total cholesterol. This suggests that WHR is a useful tool for identification of risk for metabolic syndrome markers in children. Additional research should be conducted to identify the safe and high risk range for pediatric patients, similar to what exists for the adult population. 15

16 Reportable New Information Form To replace Local SAE Reporting Form & Major Deviation Report Form. Test it out in Real Time Goal Increase Compliance! Feel free to call IRB to schedule some one-on-one time NOTE: All IRB forms (New or Revised) will be proposed at Research Matters meetings and a Comment Period will follow. 16

17 Change Request Form Use in conjunction with Reportable New Information Form Question 1 Be sure to answer all A what; B why; C how When submitting revisions to documents, PLEASE use tracked changes. It is required and reduces review time. 17

18 Please submit COI documents and other ORA documents to our department mailbox at A schedule of all classes offered by the ORA is available on the ORA website under the calendar tab. 18

19 Thank you for your attendance at Research Matters! 19