BIOGRAPHICAL SKETCH. NAME: Courcoulas, Anita P.

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1 OMB No /0002 (Rev. 08/12 Approved Through 8/31/2015) NAME: Courcoulas, Anita P. BIOGRAPHICAL SKETCH era COMMONS USER NAME: courcoulasap POSITION TITLE: Professor of Surgery; Director, Minimally Invasive Bariatric and General Surgery EDUCATION/TRAINING INSTITUTION AND LOCATION DEGREE Completion Date FIELD OF STUDY Brown University (Providence, RI) B.S Psychology/English Boston University, School of Medicine (Boston, MA) M.D Medicine University of Pittsburgh, Graduate School of Public Health () M.P.H Epidemiology A. Personal Statement As Professor of Surgery and Chief of the Minimally Invasive Bariatric and General Surgery Program at Magee- Women s Hospital of UPMC I have a strong record of excellence in clinical research and clinical care at one of the largest academic bariatric surgery programs in the country. My interests are in the study of risk stratification in bariatric surgery, volume-outcome relationships, and other outcomes in bariatric surgery target populations. I am the Principal Investigator of the NIH-NIDDK funded Triabetes Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes. Additionally, I am the Principal Investigator of the Pittsburgh site for the NIH-NIDDK funded Longitudinal Assessment of Bariatric Surgery (LABS) Study and the NIH-NIDDK funded Adolescent Bariatrics: Assessing Health Benefits and Risks (Teen-LABS) Study. B. Positions and Honors Positions and Employment Research Fellow, Liver Transplantation Database, UPMC Graduate School of Public Health, Visiting Assistant Professor of Surgery, Department of Surgery, UPMC School of Medicine, Pittsburgh PA Assistant Professor of Surgery Tenure Stream, Department of Surgery, Director, Bariatric Surgery, University of Pittsburgh Medical Center Shadyside Hospital, Fellowship Program Director, University of Pittsburgh Medical Center, Laparoscopic Bariatric Surgery Fellowship Program, Executive Committee Member, Surgical Innovation Center (SIC), Department of Surgery, Present Chief, Division of Minimally Invasive Bariatric and General Surgery, UPMC, Present Fellowship Program Director, UPMC, SAGES Fellowship Program, Associate Professor of Surgery Tenure Stream, Dept. of Surgery, UPMC School of Medicine, Pittsburgh PA Present Professor of Surgery with Tenure, Department of Surgery, UPMC School of Medicine, Other Experience and Professional Memberships 1997 American Association for the Advancement of Science 1997 Pennsylvania Medical Society 1997 Allegheny County Medical Society

2 1997 The Society for Surgery of the Alimentary Tract 1997 American Society for Bariatric Surgery 1998 Pittsburgh Gut Club and Western Pennsylvania Endoscopic Society 1998 Pittsburgh Lipid Club 1998 The Obesity-Biology Club 1999 The International Federation for the Surgery of Obesity 1999 American Obesity Association 1999 Society of Laparoendoscopic Surgeons 2001 Central Surgical Association 2002 Society Of American Gastrointestinal Endoscopic Surgeons (SAGES) 2006 Surgical Outcomes Club 2007 Society of University Surgeons 2008 American Society for Metabolic and Bariatric Surgery Fellowship 2009 Society for Clinical and Translational Science 2010 The Obesity Society 2014 American Surgical Association Fellow Honors 2003 Best Paper by New Member Award, Central Surgical Association 2005 American Society for Bariatric Surgery Outstanding Achievement Award, Nominee Patients Choice Award America s Top Doctor, Castle Connolly Medical LTD C. Contribution to Science 1. Outcomes of Bariatric Surgery Recent work has focused on longer-term weight and health outcomes in carefully studied, multi-center cohorts with detailed data on many diverse health domains. Our group was the largest clinical site in the NIH-NIDDK-funded LABS study that has made numerous significant contributions to the field with standardized data on a large number of surgical participants in a multi-site longitudinal, observational study. a. Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, Pories W, Courcoulas A, McCloskey C, Mitchell J, Patterson E, Pomp A, Staten MA, Yanovski SZ, Thirlby R, Wolfe B. Perioperative safety in the longitudinal assessment of bariatric surgery. The New England journal of medicine. 2009; 361(5): PubMed [journal] PMID: b. Courcoulas AP, Christian NJ, Belle SH, Berk PD, Flum DR, Garcia L, Horlick M, Kalarchian MA, King WC, Mitchell JE, Patterson EJ, Pender JR, Pomp A, Pories WJ, Thirlby RC, Yanovski SZ, Wolfe BM. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA. 2013; 310(22): PubMed [journal] PMID: c. Kleiner DE, Berk PD, Hsu JY, Courcoulas AP, Flum D, Khandelwal S, Pender J, Pomp A, Roerig J, Machado LL, Wolfe BM, Belle SH. Hepatic pathology among patients without known liver disease undergoing bariatric surgery: observations and a perspective from the longitudinal assessment of bariatric surgery (LABS) study. Seminars in liver disease. 2014; 34(1): PubMed [journal] PMID: d. Courcoulas AP, Christian NJ, O'Rourke RW, Dakin G, Patchen Dellinger E, Flum DR, Melissa Kalarchian PD, Mitchell JE, Patterson E, Pomp A, Pories WJ, Spaniolas K, Steffen K, Wolfe BM, Belle SH. Preoperative factors and 3-year weight change in the Longitudinal Assessment of Bariatric Surgery (LABS) consortium. Surgery for obesity and related diseases: official journal of the American Society for Bariatric Surgery. 2015; PubMed [journal] PMID: Bariatric Surgery for the Treatment of Type 2 Diabetes - There is much interest in understanding the mechanisms and durability of the effect of bariatric surgical procedures, especially gastric bypass, on type 2 diabetes outcomes. Some work in this area has been descriptive in large cohorts and other work has focused on comparative effectiveness of surgical versus non-surgical treatment options. We received one of the AARA stimulus funds comparative effectiveness research grants to study medical versus surgical treatments for lower BMI people with type 2 diabetes. This was a very successful randomized controlled trial that was

3 featured at an NIH-NIDDK and NIH-NHLBI Workshop in 2013 on the Long term outcomes from bariatric surgery that I co-chaired. a. Inge TH, Miyano G, Bean J, Helmrath M, Courcoulas A, Harmon CM, Chen MK, Wilson K, Daniels SR, Garcia VF, Brandt ML, Dolan LM.Reversal of type 2 diabetes mellitus and improvements in cardiovascular risk factors after surgical weight loss in adolescents. Pediatrics. 2009; 123(1): PubMed [journal] PMID: b. Courcoulas AP, Yanovski SZ, Bonds D, Eggerman TL, Horlick M, Staten MA, Arterburn DE. Long-term outcomes of bariatric surgery: a National Institutes of Health symposium. JAMA surgery. 2014; 149(12): PubMed [journal] PMID: c. Courcoulas AP, Goodpaster BH, Eagleton JK, Belle SH, Kalarchian MA, Lang W, Toledo FG, Jakicic JM. Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. JAMA surgery. 2014; 149(7): PubMed [journal] PMID: d. Courcoulas AP, Belle SH, Neiberg RH, et al. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. JAMA Surgery. Published online July 01, doi: /jamasurg PMID: Research Priorities and Advances in Bariatric Surgery Due to the rapid advancement of the science and literature in the field of bariatric surgery, the focus and prioritization of research goals has been an important topic of both academic and clinical interest. Several reviews and opinion pieces by this author and her colleagues have contributed to aligning current research efforts with the important needs. In addition, clinical trials for new devices have been an important part of understanding the role of new technology and innovation in the field of bariatric surgery, to which this author has also contributed. a. Courcoulas AP, Flum DR. Filling the gaps in bariatric surgical research. JAMA. 2005; 294(15): PubMed [journal] PMID: b. Courcoulas AP. Progress in filling the gaps in bariatric surgery. JAMA. 2012; 308(11): PubMed [journal] PMID: c. Arterburn DE, Courcoulas A. Bariatric surgery for obesity and metabolic conditions in adults. BMJ (Clinical research ed.). 2014; 349:g3961.PubMed [journal] PMID: d. Eid GM, McCloskey CA, Eagleton JK, Lee LB, Courcoulas AP. StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients: a randomized clinical trial. JAMA surgery. 2014; 149(4):372-9.PubMed [journal] PMID: Psychosocial Outcomes and Special Populations in Bariatric Surgery An important area for study are the psychosocial predictors of effects and the psychosocial outcomes of bariatric surgery. Our group was one of the first to characterize the baseline/pre-surgical characteristics of the population seeking surgery. We have studied the impact of surgery on depression and substance misuse and completed one of the first populationbased studies on the increased risk of suicide. We have also been interested in the outcomes of surgery in special populations, such as adolescents. The work from Teen LABS has made significant contributions to a growing body of literature by examining baseline co-morbid conditions, short term safety outcomes, and outcomes from various health domains including psychosocial and musculoskeletal. a. Kalarchian MA, Marcus MD, Levine MD, Courcoulas AP, Pilkonis PA, Ringham RM, Soulakova JN, Weissfeld LA, Rofey DL. Psychiatric disorders among bariatric surgery candidates: relationship to obesity and functional health status. The American journal of psychiatry. 2007; 164(2):328-34; quiz 374.PubMed [journal] PMID: b. Tindle HA, Omalu B, Courcoulas A, Marcus M, Hammers J, Kuller LH. Risk of suicide after long-term follow-up from bariatric surgery. The American journal of medicine. 2010; 123(11): PubMed [journal] PMID: c. King WC, Chen JY, Mitchell JE, Kalarchian MA, Steffen KJ, Engel SG, Courcoulas AP, Pories WJ, Yanovski SZ. Prevalence of alcohol use disorders before and after bariatric surgery. JAMA. 2012; 307(23): PubMed [journal] PMID: d. Kalarchian MA, Marcus MD, Courcoulas AP, Cheng Y, Levine MD. Preoperative Lifestyle Intervention in Bariatric Surgery: A Ramdomized Clinical Trial. Surg Obes Relat Dis May 8. pii: S (15) doi: /j.soard [Epub ahead of print] PMID: Bariatric Surgery in Adolescents The utilization of bariatric surgery in the younger population is a more recent area of research focus, based on clinical experience and as the only adult primary site in the Teen

4 LABS Consortium. The work from Teen LABS has made significant contributions to this growing body of literature by examining baseline co-morbid conditions, short term safety outcomes, and outcomes from health domains including psychosocial and musculoskeletal. a. Inge TH, Zeller M, Harmon C, Helmrath M, Bean J, Modi A, Horlick M, Kalra M, Xanthakos S, Miller R, Akers R, Courcoulas A. Teen-Longitudinal Assessment of Bariatric Surgery: methodological features of the first prospective multicenter study of adolescent bariatric surgery. Journal of pediatric surgery. 2007; 42(11): PubMed [journal] PMID: b. Inge TH, King WC, Jenkins TM, Courcoulas AP, Mitsnefes M, Flum DR, Wolfe BM, Pomp A, Dakin GF, Khandelwal S, Zeller MH, Horlick M, Pender JR, Chen JY, Daniels SR. The effect of obesity in adolescence on adult health status. Pediatrics. 2013; 132(6): PubMed [journal] PMID: c. Inge TH, Zeller MH, Jenkins TM, Helmrath M, Brandt ML, Michalsky MP, Harmon CM, Courcoulas A, Horlick M, Xanthakos SA, Dolan L, Mitsnefes M, Barnett SJ, Buncher R. Perioperative outcomes of adolescents undergoing bariatric surgery: the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study. JAMA pediatrics. 2014; 168(1):47-53.PubMed [journal] PMID: d. Inge TH, Courcoulas AP, Jenkins TM, Michalsky MP, Helmrath MA, Brandt ML, Harmon CM, Zeller MH, Chen MK, Xanthakos SA, Horlick M, Buncher CR: Teen-LABS Consortium. Weight Loss and Health Status 3 Years after Bariatric Surgery in Adolescents. N Engl J Med. 2016; 374: PubMed [journal] PMID: Complete List of Published Work: direction=ascending D. Research Support Ongoing Research Support (Selected) 5U01DK Courcoulas (PI) 9/30/2003 6/30/2016 Effect of Bariatric Surgery on Insulin & CVD This is a multi-site cooperative agreement designed to study medical, physiological, and behavioral effects of bariatric surgery. At the University of Pittsburgh, this is the grant that funds the Longitudinal Assessment of Bariatric Surgery (LABS). Additionally, this grant funds two substudies (LABS-3): Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery (Role: Consultant) and Psychosocial Issues and Bariatric Surgery (Role: Co-Investigator). Role: PI Industry (Schauer) Courcoulas (PI) 2/19/2015 2/18/2017 Ethicon Endo-Surgery & Covidien ARMMS-T2D: Alliance of Randomized trials of Medicine vs. Metabolic Surgery in Type 2 Diabetes This project provides mid-term bridge multi-center extension to four randomized trials comparing surgical and medical treatments in Type 2 Diabetes which includes the Triabetes Study (A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes). This study compares outcomes of 3 of the most common bariatric surgical procedures with a comprehensive medical treatment for Type 2 Diabetes in a large cohort of randomized patients (>300) with body mass index between 30 and 40. IU34DK Courcoulas (PI) 8/27/ /30/2017 Alliance of Randomized trials of Medicine vs. Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) Consortium This project provides the planning phase to obtain a U01 grant for long-term multi-center study designed to assess the durability and effectiveness of bariatric surgery compared to medical/lifestyle management of T2D in obese patients at seven or more years. The U34 project will focus on harmonization of four randomized trials comparing surgical and medical treatments in Type 2 Diabetes which includes the Triabetes Study (A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes).

5 R01DK Gallagher (PI) 09/30/05 06/30/2016 Body Composition and REE Response to Bariatric Surgery This ancillary study to the LABS consortium identifies and measures the important components of weight change in patients undergoing different types of bariatric surgery on measure of fat mass and its distribution and FFM (including bone mineral density, skeletal muscle, and specific organs) over 4 years. Role: Consultant 5UM1DK Inge (PI) 09/23/2011 3/31/2017 Adolescent Bariatrics: Assessing Health Benefits and Risks (Teen LABS). This is a prospective, longitudinal study that examines the impact of gastric bypass surgery as treatment for severe obesity by measuring comorbidities, health outcomes, complications and quality of life in adolescents. R01DK Courcoulas (PI) 05/16/2012 4/30/2016 A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes Extension to the Triabetes Study for longer-term follow-up of a Randomized Trial to compare Surgical and Medical Treatments for Type 2 Diabetes and to compare outcomes of 2 of the most common bariatric surgical procedures with a comprehensive medical treatment for Type 2 Diabetes in a randomized fashion for patients with body mass index between 30 and 40. Role: PI (sole) R01DK Arterburn (PI) 9/15/15 7/31/2019 Long-term Benefits and Risks of Bariatric Surgery in Integrated Care Systems (DURABLE) The proposed project will be the largest study to date to investigate the long-term relationships between bariatric surgery and durable improvements in body weight, hypertension, and renal disease, as well as its association with major operative complications and long-term survival. These outcomes will be compared to a population-based cohort of severely obese patients who have not had weight loss surgery. Role: Scientific Co-Investigator PCORI Arterburn (PI) 2/1/2016-1/31/2018 PCORnet Bariatric Surgery Study The main goal of the proposed study is to provide accurate estimates of the one-, three-, and five-year benefits and risks of the three most common bariatric procedures. This study will involve 10 of PCORnet s Clinical Data Research Networks (CDRNs) including 53 healthcare organizations and more than 60,000 bariatric patients. Role: Co-Investigator R01DK Stylopoulos (PI) 9/24/2015-8/31/2018 Intestinal Metabolic Reprogramming as a Key Mechanism of Gastric Bypass in Humans This is a descriptive, observational, longitudinal trial where the metabolism of the Roux limb of the small intestine will be analyzed in patients who have had Roux-in-Y Gastric Bypass surgery (RYGB). This analysis will include the time course of its adaptive changes in patients with Class II and Class III obesity, who have eight Type 2 diabetes (T2DM) or people who do not (study groups). Role: Co-Investigator

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