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1 Statement of Funds

There are no other funds for this related project pending or on hand through other sources.

Dietary INtake and TAste changes for KEeping weight off after bariatric surgery: INTAKE after weight loss intervention

Summary

Although bariatric surgery is known to be effective for the treatment of obesity and associated disease risks, treatment response varies. We hypothesize that one reason for inconsistency in long-term treatment response is a variable change in taste preferences that leads to changes in food intake. The primary objective of this study is to investigate the relationship between taste preference and dietary intake post bariatric surgery. Obese adults (BMI>35kg/m2, 18-55 years old) undergoing elective vertical sleeve gastrectomy (n=17) or Roux-en Y gastric bypass (n=17), and controls who are undergoing medical weight loss (n=17) will be recruited (total n=51 adults). Participants will be asked to complete taste tests using a range of fat and sweet solutions at baseline (1-4 weeks prior to intervention), and again at 3, 6, and 12 months after the intervention. Participants will also be asked to complete validated questionnaires regarding reward sensitivity, binge eating disorder, and impulsivity at these study visits. Within 10 days of each taste test, but prior to any intervention, three 24-hour dietary recalls will be collected for each participant. It is expected that adults undergoing bariatric surgery will experience a decreased preference for sweet and fat and this will be associated with a decrease in dietary fat and sugar intake. Results of this study will contribute to the knowledge of post-surgical treatment success and potentially result in changes in the approach to treating obesity.

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2 Background

Although bariatric surgery is known to be effective for the treatment of obesity and associated disease risks, treatment response varies. A better understanding of the mechanisms through which bariatric surgery facilitates weight loss may help identify individuals at risk for poor surgical outcomes, weight regain, and/or need for additional treatments and therapies after surgery.

While the number of bariatric surgeries performed has increased (1), the most popular surgeries are Sleeve Gastrectomy (42.1%), Roux-en-Y Gastric Bypass (RYGB) (34.2%), and gastric band (14.0%). Patients undergoing RYGB generally have excellent results, with weight loss reaching 75-80% of excess body weight, resolution of diabetes, and improvements in many other obesity-related conditions. Vertical sleeve gastrectomy produces similar weight loss and improvements in comorbidities. (2) However, these procedures are not

successful in all patients. Rates of treatment failure, defined as inadequate reductions in either BMI or % excess weight have been found in 11-20% in patients with pre-surgical morbid obesity and 9.1-34.9% in patients with super obesity (BMI >50) 2-10 years after RYGB. (3-5) Studies of patients 1-10 years post-bariatric surgery have found weight regain of >10% of weight lost in 47-60.6% of participants (6, 7) and weight regain of >15% of total weight lost in 15% of participants (8). In order to reduce rates of treatment failure, more evidence is needed to uncover potential contributors to inadequate weight reduction and weight regain. A growing body of research has revealed that bariatric surgery techniques work not only through anatomic alterations resulting in gastric restriction and/or malabsorption, but also by producing numerous metabolic effects and changes in dietary behavior. (9) Similarly, factors associated with weight regain have been categorized into anatomic, behavioral, psychological, and hormonal/metabolic elements. (10)

A novel hypothesis explaining obesity suggests that abnormalities in taste and food preferences lead to

increased liking and wanting of food, which in turn leads to overeating. We hypothesize that bariatric surgical interventions, conversely, induce alterations in taste that facilitate weight loss through changes in dietary intake. Taste is a salient concern to individuals when making decisions about food purchasing or consumption (11, 12). Taste is also important in determining hedonic response to foods, which has been identified as an important factor in reinforcing food intake. (13) Salbe et al.(14) found that greater hedonic response to sweet and creamy solutions was correlated with greater weight gain at the end of five years among an obesity-prone population of Pima Indians. Increased taste sensitivity, or the ability to detect a taste at a lower concentration, has been found for all tastes after bariatric surgery, with sweet being the most commonly studied. (15-17) Most studies have found decreased preference for sweets or fat after bariatric surgery, however these studies have methodological limitations including small sample size, reliance on surveys instead of measured taste preferences, and assessing a limited or undefined timeframe after surgery. (18-20)

It is possible that change in taste preferences decreases the reward value of food, disrupts reward mechanisms encouraging overconsumption, or contributes to reinforcement of dietary intake changes following bariatric surgery. In 1994, Brolin (21) noted a reduction in sweets and soda consumption 24 months after RYGB

compared to pre-operative levels. Several other studies have also noted reductions in proportion of calories from sweetened foods and beverages after RYGB, although this finding is not universal. (22) More recently, Olbers found reductions in the proportion of calories consumed up to one year after surgery for both gastric banding and gastric bypass patients, with a significantly greater reduction in the gastric bypass group. (23) Dietary factors associated with weight regain after bariatric surgery include eating more calories, snacks and sweets, and oily or fatty foods (6), grazing (7), and experiencing loss of control over eating/food urges (7, 8). Taste may drive changes in dietary intake, however many other variables also play a potential role in dietary selection including cost, convenience, food access, cultural and family traditions, social norms, health considerations, and psychological and behavioral factors related to eating.

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3

The proposed study will help clarify whether taste changes following surgery are related to alterations in diet and possibly other psychological or behavioral responses to surgery. To date, the relationship of taste changes to diet intake and weight trajectory has not been studied in humans post bariatric surgery.

Capturing actual dietary intake data allows for an objective assessment of changes in the amount and types of food and beverages consumed over the course of the study. These dietary variables could potentially mediate the relationships between neurobehavioral factors and treatment response to bariatric surgery. Dietary intake data will allow us to analyze the potential relationships between specific dietary changes or patterns and taste preference, feeding behaviors, and weight trajectory. Understanding these relationships could improve identification of patients at risk for poor treatment response to bariatric surgery and potentially inform specific treatments to improve outcomes.

The Johns Hopkins Institute for Clinical and Translational Research (ICTR) Nutrition Core has been working with Dr. Kimberley Steele, the PI for this application, in a study entitled “Neurobiologic Alterations in Bariatric Surgery: Taste Responsiveness and Weight loss.” Dr. Steele’s study is investigating functional magnetic resonance imaging (fMRI) changes and taste preferences using blind taste tests with a variety of sucrose and fat-containing solutions before the initiation of weight loss (surgery or usual care) and 2 weeks, 3 months, 6 months, and 12 months after weight loss treatment. Participants also complete a set of validated questionnaires at all visits to better define their reward sensitivity, binge eating behavior, and impulsivity. The fMRI study is making important contributions to address many of the limitations in the current taste literature and adds a novel neurobiological component. However, participants must be eligible and willing to complete an fMRI scan. This limits participation of individuals with super obesity who are unable to fit in the scanner, those with central nervous system dysfunction, neurological illnesses, and those taking psychotropic medications. Considering that 27-47% of bariatric surgery patients require psychotherapeutic medications, this may represent a significant exclusion factor. (24-26) Dr. Steele’s fMRI study also does not currently include any assessment of diet intake. We therefore propose a sub-study that will include taste tests, validated eating behavior questionnaires, and diet assessment in individuals who qualify for all aspects of the parent study except the fMRI scan. We will examine data from the baseline and 3, 6, and 12 month time points. At two-weeks prior to surgery, the surgery

intervention groups are required to begin a liquid weight loss diet. We will complete diet recalls prior to the pre-surgical weight loss diet. Additionally, two weeks post-bariatric surgery we anticipate postoperative recovery pureed diet to be a significant confounder of the taste/intake relationship and therefore we will not collect diet data at this 2-week post-surgery time.

The proposed study will enable further investigation into whether change in taste after surgery, or lack thereof, is associated with consumption, behavioral drivers of food intake, and perhaps treatment outcome. Importantly, our study will include subpopulations that are highly vulnerable to treatment failure such as those with pre-surgical super obesity or those taking psychotropic medications. Dr. Steele’s fMRI study has had two years of successful recruitment, and we expect equal or better recruitment given the expanded inclusion criteria and reduced participant burden. Data from this preliminary trial have the potential to identify trends and possible associations for further investigation. A larger trial could ultimately increase understanding of the role of taste in body weight regulation, improve treatment protocols, and perhaps lead to creating novel surgical and non-surgical therapies for obesity.

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4 Hypothesis

Specific Aim 1. To determine whether percent of calories from added sugar, total sugar, and fat (from 24-hour diet recalls) are correlated with taste responsiveness to sweet and fat (from taste tests) at all time points.

Hypothesis 1A: At 3 months, 6 months, and 12 months post-intervention, percent of calories from added sugar, total sugar, and fat will be positively correlated with taste preference for all treatment groups.

Hypothesis 1B: Preference for sweet taste and intake of total and added sugar (as a % of calories) are directly related, such that a change in preference for sweet compared to baseline will be predictive of a change in percent of calories from added sugar and total sugar in all groups at all post intervention time points.

Hypothesis 1C: Preference for fat and intake of fat (as a % of calories) are directly related, such that a change in preference for fat compared to baseline will be predictive of a change in percent of calories from fat in all groups at all post intervention time points.

Specific Aim 2. To determine whether change in taste (from taste tests) at 3, 6, and 12 months is

associated with weight loss at 12 months, controlling for total calories consumed (from 24 hour recalls). Hypothesis 2A: Taste preference for both sweet and fat at baseline 3, 6, and 12 months post-intervention will be indirectly related to weight reduction at 12 months.

Hypothesis 2B: Decreased preference for sweet at 3, 6, and 12 months compared to baseline will be directly related to weight reduction at 12 months after controlling for total calorie intake.

Hypothesis 3B: Decreased preference for fat at 3, 6, and 12 months compared to baseline will be directly related to weight reduction at 12 months after controlling for total calorie intake.

Descriptive statistics will be used to summarize data from eating behavior questionnaires in order to characterize potential behavioral mediators, (frequency of food craving, binge behaviors, food restraint).

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5 Methods

Study Design: This is a pilot study testing taste changes before and after weight loss intervention in three treatments groups: vertical sleeve gastrectomy (VSG), Roux-en Y gastric bypass (RYGB), or diet and exercise. Participants in each study group will participate in a taste evaluation by responding to a 100mm visual analog scale and will complete 3 diet recalls at 4-6 weeks prior to the intervention, and 3, 6, and 12 months post intervention.

Participants: A total of 51 adults will be enrolled in the study. Subjects will include 34 patients who qualify for bariatric surgery (VSG, n=17 and RYGB, n=17) at the Johns Hopkins Center for Bariatric Surgery and 17 obese controls treated with a diet-induced weight loss plan at The Johns Hopkins Weight Management Center. Obese participants must meet inclusion and exclusion criteria as outlined below.

Inclusion Criteria: To be eligible for the study, patients must meet all of the following inclusion criteria at screening and must continue to meet these criteria to remain enrolled in the study.

Bariatric Participants:

1. Ages 18 to 55 years old 2. BMI of 35 or greater

3. Completed and signed informed consent.

4. Medically and psychologically evaluated and approved for RYGB or VSG surgery by The Johns Hopkins Center for Bariatric Surgery

Obese Controls: Must meet criteria 1 - 3 as above Exclusion Criteria:

1. Smokes > 2 packs of cigarettes per day 2. Pregnant or lactating

3. Currently experiencing a serious medical condition that would place the subject at risk or interfere with the study participation.

4. Have a less than 5th grade reading level.

5. Have any reasons that may cause altered taste acuity. For example: Zinc and/or B12 deficiency, Inflammatory Bowel Disease, severe gingivitis or on medication that may alter taste (Metronadiozole). 6. Lactose intolerance

Baseline Measures

At least two weeks prior to any pre-intervention weight loss, all participants will be contacted to obtain a verbal consent for three twenty-four hour pre-intervention diet recalls. All study participants will undergo a standard medical examination 1-4 weeks prior to the intervention and after written informed consent for the study. Weight will be measured in light clothes without shoes by trained research staff using a calibrated Scaletronix digital scale. Scale calibration will be checked daily by study personnel using standard weights. Height to the nearest 0.1 cm will be measured in duplicate using a calibrated, wall-mounted Harpenden stadiometer. The participant will stand shoeless on a firm, level surface, with the head in the Frankfort plane. Body mass index (BMI) will be calculated (kg of measured body weight/height in m2). Waist circumference will be measured by trained research staff using an anthropometric measuring tape, at a horizontal plane that is one cm above the navel. Duplicate measurements will be made of all anthropometric measures to ensure precision. Taste preferences will be evaluated using the standard 9-point hedonic preference scale (Figure 1) in order to support specific aims 1 and 2. Subjects will be asked to complete the validated questionnaires described below. The survey results will be used to describe potential mediators of behavior that may affect taste and intake as described in specific aim 1. All surveys will be delivered electronically.

Food Craving Inventory (FCI): This questionnaire is a reliable measure of general and specific food liking and food craving. (27)

Binge Eating Scale (BES): This questionnaire assesses binge eating behaviors primarily by identifying behavioral characteristics (e.g. how much food is consumed) and assessing the emotional cognitive response. (28)

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6

Three Factor Eating Questionnaire (TFEQ): The TFEQ is widely used in obesity research. Reliability and internal consistency has been documented. It includes three subscales (dietary restraint, disinhibition, and hunger) and can predict weight loss and regain outcomes associated with obesity treatment. (29)

Taste Evaluation (standard 100 mm visual analog scale): Twelve milk-based samples of varying sucrose and fat concentrations will be given to participants. Taste samples will be introduced in a random order to reduce taste discrimination and fatigue. The samples will be chilled to 5°C and served to participants in 30cc plastic cups. Participants will be instructed to taste the various samples without swallowing, followed by expectoration, and water mouth rinse between tastings. The 100 mm visual analog preference scale (Figure 1) will be utilized to assess the participant’s taste responsiveness.

Figure 1. 100 mm Visual analog taste preference scale

Table 1. Taste Test Sample Components Table 1 describes the sucrose and fat-containing

samples that will be used for the taste test. Four products (skim milk, whole milk, half and half, and heavy cream) will be combined with sucrose at levels 0, 10, and 20% wt/wt,totaling 12 taste samples (tastants).

Dietary intake collection:

Within 10 days of the taste test, three 24-hour

dietary recalls will be collected for each participant. Trained research staff from Johns Hopkins Institute for Clinical and Translational Research (ICTR) Research Nutrition Core will administer 24 hour dietary recalls by phone using the United States Department of Agriculture Multiple Pass Method within the Nutrition Data System for Research (NDSR). Study participants will receive the Food Amounts Booklet which contains information to assist them in giving 24 hour recalls. Three recalls (goal: 2 weekdays and one weekend day) will be conducted within 10 days of the taste test in order to support specific aims 1 and 2.

Follow-up: Anthropometric measures (height, weight, and waist circumference), taste tests, dietary recalls, and surveys will be repeated at 3, 6, and 12 months post intervention for all three study groups.

Sample Size: This study is a pilot project which will not provide adequate power to determine statistically significant change in taste perception or dietary intake of fat and sugar. We do expect to see a trend towards change in taste. Data from this pilot study will be used to establish power for a larger study.

Data Analysis: Baseline characteristics among the three treatment groups described using ANOVA for

continuous variables and fisher’s exact tests for categorical variables. Chi Square will be used to describe eating behavior survey results at each visit. For exploratory analysis, spaghetti plots between the percent of calories from added sugar, total sugar, total fat intake, and the taste preferences (hypothesis 1 A-C) as well as taste versus weight loss (hypotheses 2A-C) will be generated to exam how the relationship between them changes over time/visits and whether they are different among the three treatment groups. If the plots show linear trend in the relationship, time/visits will be used as a continuous variable in the regression models. Otherwise, the visit variable will be categorical. The linear mixed effects regression model will be used to regress the percent calories on taste preferences (hypothesis 1C) and also for taste change on weight loss (hypothesis 2C), with indicator variables for treatment groups and the visit variable. A random intercept for participants will be included to account for the correlation among the repeated measures from the same participant. As the

relationship may change differently overtime for different treatment groups, the interaction terms between the visit variable and the indicator variable for the treatment groups will be explored.

Sucrose and Fat-containing Stimuli Additive Fat per 100 g

(g)

Sucrose Levels (% wt/wt)

Skim milk 0.1 0 10 20

Milk 3.5 0 10 20

Half and half 10.5 0 10 20

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09BudgetSheet_r2

Detailed budget for 12 month period from January 02 2017 through January 1, 2018. Dollar amount requested (Omit cents) 30,000

Total for the grant request may not exceed $30,000.

* Salary funds should be used for staff required to execute the study, but should not be used for salary support for the primary investigator. If salary support exceeds 50% of the project budget, then specific justification is required.

**Funds requests for travel for the presentation of a SAGES funded study should be limited to $1,000.

POSITION TITLE SALARY FRINGE BENEFITS SUB-TOTALS

% Hrs/ Week

1. Kimberley Steele Principal Investigator* 10 4

2. Amy Schweitzer Project Director 10 4

Christopher Stewart Research Coordinator 6% 2 2401 816 3218

4. 5.

CONSULTANT COSTS

EQUIPMENT

(List all Items&Total Equipment Cost) Subtotal

SUPPLIES

(List all Items&Total Supplies Cost) $4,794

TRAVEL** $578

PATIENT CARE COSTS $1,020

CONSORTIUM/CONTRACTUAL COSTS

OTHER EXPENSES

(List all Items & Total Cost) $20,390

TOTAL DIRECT COSTS $30,000

SAGES Annual Meeting

Patient compensation $20 per participant *51 participants

SAGES RESEARCH GRANT APPLICATION

BUDGET SHEET

TIME/EFFORT

n/a

Biostats services 5 hours at $100 per hour.

24 hour recall $32.50 x 3 per study visit x 4 visits x 51 participants Items

Items: Taste test supplies (skim milk, whole milk, half and half, heavy cream, sugar, cups) $23.5 x 4 time points X 51 subjects)

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References

1 Surgery ASfMaB. New Procedure Estimates for Bariatric Surgery. Connect the official news magazine of ASMBS 2014 [cited 2016 6/13/2016]; May 2014:[Available from: http://connect.asmbs.org/may-2014-bariatric-surgery-growth.html

2 Bour ES. Evidence supporting the need for bariatric surgery to address the obesity epidemic in the United States. Current sports medicine reports. 2015 Mar-Apr;14(2):100-3.

3 Christou NV, Look D, Maclean LD. Weight gain after short- and long-limb gastric bypass in patients followed for longer than 10 years. Annals of surgery. 2006 Nov;244(5):734-40.

4 Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obesity surgery. 2008 Jun;18(6):648-51.

5 Valezi AC, de Almeida Menezes M, Mali J, Jr. Weight loss outcome after Roux-en-Y gastric bypass: 10 years of follow-up. Obesity surgery. 2013 Aug;23(8):1290-3.

6 Freire RH, Borges MC, Alvarez-Leite JI, Toulson Davisson Correia MI. Food quality, physical activity, and nutritional follow-up as determinant of weight regain after Roux-en-Y gastric bypass. Nutrition. 2012 Jan;28(1):53-8.

7 Kofman MD, Lent MR, Swencionis C. Maladaptive eating patterns, quality of life, and weight outcomes following gastric bypass: results of an Internet survey. Obesity. 2010 Oct;18(10):1938-43.

8 Odom J, Zalesin KC, Washington TL, et al. Behavioral predictors of weight regain after bariatric surgery. Obesity surgery. 2010 Mar;20(3):349-56.

9 Madsbad S, Dirksen C, Holst JJ. Mechanisms of changes in glucose metabolism and bodyweight after bariatric surgery. The Lancet Diabetes & Endocrinology. 2014;2(2):152-64.

10 Dykstra MA, Switzer NJ, Sherman V, Karmali S, Birch DW. Roux en Y Gastric Bypass: How and Why it Fails? Surgery: Current Research. 2014;04(02).

11 Dressler H, Smith C. Food choice, eating behavior, and food liking differs between lean/normal and overweight/obese, low-income women. Appetite. 2013 Jun;65:145-52.

12 Glanz K, Basil M, Maibach E, Goldberg J, Snyder DAN. Why Americans Eat What They Do. Journal of the American Dietetic Association. 1998;98(10):1118-26.

13 Mela DJ. Determinants of food choice: relationships with obesity and weight control. Obesity research. 2001 Nov;9

Suppl 4:249S-55S.

14 Salbe AD, DelParigi A, Pratley RE, Drewnowski A, Tataranni PA. Taste preferences and body weight changes in an obesity-prone population. The American journal of clinical nutrition. 2004 Mar;79(3):372-8.

15 Bueter M, Miras AD, Chichger H, et al. Alterations of sucrose preference after Roux-en-Y gastric bypass. Physiology & behavior. 2011 Oct 24;104(5):709-21.

16 Scruggs DM, Buffington C, Cowan GS, Jr. Taste Acuity of the Morbidly Obese before and after Gastric Bypass Surgery. Obesity surgery. 1994 Feb;4(1):24-8.

17 Burge. Changes in Patients’ Taste Acuity after Roux-en-Y Gastric Bypass for Clinically Severe Obesity. 1995.

18 Pepino MY, Bradley D, Eagon JC, Sullivan S, Abumrad NA, Klein S. Changes in taste perception and eating behavior after bariatric surgery-induced weight loss in women. Obesity. 2014 May;22(5):E13-20.

19 Thirlby RC, Bahiraei F, Randall J, Drewnoski A. Effect of Roux-en-Y gastric bypass on satiety and food likes: the role of genetics. Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract. 2006 Feb;10(2):270-7.

20 Tichansky DS, Boughter JD, Jr., Madan AK. Taste change after laparoscopic Roux-en-Y gastric bypass and

laparoscopic adjustable gastric banding. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2006 Jul-Aug;2(4):440-4.

21 Brolin RE, Robertson LB, Kenler HA, Cody RP. Weight loss and dietary intake after vertical banded gastroplasty and Roux-en-Y gastric bypass. Annals of surgery. 1994 Dec;220(6):782-90.

22 Mathes CM, Spector AC. Food selection and taste changes in humans after Roux-en-Y gastric bypass surgery: a direct-measures approach. Physiology & behavior. 2012 Nov 5;107(4):476-83.

23 Olbers T, Bjorkman S, Lindroos A, et al. Body composition, dietary intake, and energy expenditure after laparoscopic Roux-en-Y gastric bypass and laparoscopic vertical banded gastroplasty: a randomized clinical trial. Annals of surgery. 2006 Nov;244(5):715-22.

24 Latner JD, Wetzler S, Goodman ER, Glinski J. Gastric bypass in a low-income, inner-city population: eating disturbances and weight loss. Obesity research. 2004 Jun;12(6):956-61.

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25 Pawlow LA, O'Neil PM, White MA, Byrne TK. Findings and outcomes of psychological evaluations of gastric bypass applicants. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2005 Nov-Dec;1(6):523-7; discussion 8-9.

26 Sarwer DB, Cohn NI, Gibbons LM, et al. Psychiatric diagnoses and psychiatric treatment among bariatric surgery candidates. Obesity surgery. 2004 Oct;14(9):1148-56.

27 White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and validation of the food-craving inventory. Obesity research. 2002 Feb;10(2):107-14.

28 Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addictive behaviors. 1982 1982/01/01;7(1):47-55.

29 Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. Journal of psychosomatic research. 1985 //;29(1):71-83.

30 Miller GD, Norris A, Fernandez A. Changes in nutrients and food groups intake following laparoscopic Roux-en-Y gastric bypass (RYGB). Obesity surgery. 2014 Nov;24(11):1926-32.

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10 Local/Institution Review Board

In anticipation of receiving funding, Dr. Steele has received IRB approval from Johns Hopkins Medical

Institute IRB for change in research to include taste tests and the collection of diet recalls in those who are not eligible for fMRI scans but otherwise meet inclusion criteria for this sub study.

eIRB:

FYI - Do not reply IRB Approved Confirmation

Study Number: CIR00022015

Study Name:

Change In Research: CIR00022015 For: NA_00084380

Parent Study Name: Neurobiologic Alterations in Bariatric Surgery: Taste Responsiveness and Weight loss

PI: Kimberley Steele

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11 Available Resources

All other resources required to carry-out this proposal are easily accessible to the Program Director, Dr. Schweitzer, and PI-Dr. Steele. Amy Schweitzer, PhD, RD, LDN, a member of the ICTR Nutrition Core, was responsible for coordinating the writing of the grant and will continue to direct the project with Dr. Steele, and others from the ICTR Nutrition Core: Susan Oh, Diane Vizthum, MS, RD, LDN, and Caitlin Krekel, MPH, RD, LDN. Dr. Steele will be responsible for recruiting of the bariatric patients and diet-induced weight loss patients. The Institute for Clinical and Translational Research (ICTR) Clinical Research Units and Research Nutrition Core will be utilized to carry-out taste tests, questionnaires, and diet recalls as well as provide additional resources under the direction of Susan Oh, MS, RD, LDN. The ICTR provides five hours of Biostatistician’s time, clinical space, dedicated research nursing staff under the National Center for Research Resources and the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health through Grant Number 1UL1TR001079. An additional 5 hours at $100/hr of additional Biostatistics time are required to perform basic data analysis. Taste test supplies and dietary recalls costs are outlined in the table above.

Additional funds to support travel to SAGES annual meeting, the remaining costs will be met with Johns Hopkins University tuition remission.

Johns Hopkins ICTR: • efforts by Dr. Steele • efforts by Susan Oh

• five hours of Biostatistician time,

• the following facilities and equipment in the outpatient research department of Johns Hopkins University:

o telephones for conducting diet recalls,

o computers for conducting surveys, communicating with team members, for storing and evaluating data, etc

o Nutrition Data System for Research (NDSR), o exam room,

o Harpenden stadiometer, o Scaletronix digital scale,

o Commercial, hospital grade refrigeration

The SAGES Grant if awarded will provide: • Effort by the study coordinator,

• Additional five hours of Biostatistician effort

• 12 diet recalls each for all 51 participants (total =612) • Patient compensation

• Taste test supplies and equipment including: o Skim milk

o Whole milk o Heavy cream oil o Sampling vessels

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OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015)

BIOGRAPHICAL SKETCH

Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Kimberley Eden Steele, M.D., Ph.D., F.A.C.S. eRA COMMONS USER NAME: ksteele3

POSITION TITLE: Associate Professor

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include

postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

INSTITUTION AND LOCATION

DEGREE (if applicable) Completion Date MM/YYYY FIELD OF STUDY

University of Toronto, Toronto Ontario Canada University of Toronto, Toronto Ontario Canada Ross University School of Medicine, Dominica Penn State University School of Medicine, Hershey Pennsylvania

The Johns Hopkins University School of Medicine, Baltimore, Maryland

The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland BS Honors BS MD Surgical Residency Surgical Fellowship Ph.D. 05/1990 05/1995 06/2000 06/2005 06/2006 05/2014 Biology / Anthropology Human Biology/German Medicine Surgery

Minimally Invasive and Bariatric Surgery Graduate Training in Clinical Investigation

A. Personal Statement

As a bariatric surgeon and clinician scientist, I have been actively involved in studying various aspects of obesity and the associated diseases. My interest in this area began during my bariatric fellowship, when I was struck by the variability in long-term surgical outcomes among bariatric patients. Eager to learn why this was so, I began my first project studying the relationship between body mass index (BMI) and dopamine (DA). I published our results in 2010, under a grant from the Association of Women Surgeons. In our 5 subjects, DA receptor availability increased following gastric bypass surgery. Ours was the first of only two published studies examining the relationship of DA and obesity in the bariatric population. Following this research, I received a 2-year NIH Roadmap K12 Clinical Research Award and completed my Ph.D. We have now begun a project using fMRI to study the changes in taste that may occur following bariatric surgery. It has been my observation that many Roux-en Y gastric bypass (RYGB) patients develop an aversion to sweets and high-fat foods immediately following surgery. This aversion does not persist indefinitely, returning to a pre-surgical pattern within a year. The taste changes that occur in the bariatric patient may be a result of neurobiologic changes in the reward regions of the brain, specifically the dorsal and ventral striatum. Elucidation of the mechanisms responsible for these taste changes could lead to the development of alternative or improved weight loss methods, such as pharmacologic agents, to induce weight loss. As a result of this study, I have had the honor and pleasure to work with my colleagues in research nutrition including Dr. Amy Schweitzer. Dr. Schweitzer and the nutrition team were instrumental in the design and writing of this grant submission. The team is eager to elucidate the relationship between taste preference and dietary intake post bariatric surgery. A better understanding of whether taste changes following surgery are related to alterations in diet and possibly other psychological or behavioral responses to the specific weight loss intervention could improve identification of patients at risk for poor treatment response to bariatric surgery and potentially inform specific treatments to improve outcomes.

1. Steele KE, Prokopowicz GP, Schweitzer MA, Magnuson TH, Lidor AO, Kuwabawa H, Kumar A, Brasic J, Wong DF. Alterations of Central Dopamine Receptors Before and After Gastric Bypass Surgery. Obesity Surgery, 2010; 20:369-374. 2. Steele KE, Lidor A, Magnuson T, Wong D, Schweitzer MA. Obesity and the Brain: Implications for the Surgeon.

Bariatric Times. 2011; 8(7):12–13.

B. Positions and Honors

2006-2007 Instructor, Johns Hopkins University School of Medicine, Department of Surgery

2006-2011 Co-Director of the Surgical Clerkship, Johns Hopkins University School of Medicine-JHBMC 2007-2014 Assistant Professor, Johns Hopkins University School of Medicine, Department of Surgery 2009-present Director of Adolescent Bariatric Surgery, Johns Hopkins Center for Bariatric Surgery 2009-present Director of Surgical Simulation and Education - Johns Hopkins Bayview Medical Center 2010-present Director of the Johns Hopkins Center for Bariatric Research and Innovation

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2012-2014 Associate Director of the Center for Trials and Outcomes Research (CSTOR) Department of Surgery 2014-present Associate Professor, Johns Hopkins University School of Medicine, Department of Surgery

Other Experience and Professional Memberships:

2001-2005 Pennsylvania Medical Society, Dauphin County 2003-present American College of Surgeons (ACS) 2004-present Association of Women Surgeons (AWS)

2004-present Society of American Gastrointestinal Endoscopic Surgeons (SAGES) 2006-present Association of Surgical Education (ASE)

2006-present American Society of Metabolic and Bariatric Surgeons (ASMBS) 2007-present Fellow of the American College of Surgeons (FACS)

2009-present Association of Academic Surgeons (AAS)

2006-present Bariatric Center of Excellence Committee at Johns Hopkins Bayview Medical Center 2007-present Surgical Resident Education Committee at Johns Hopkins University School of Medicine

01/17-19/2009 Consultant: Center for Disease Control and Prevention, US Medical Eligibility Criteria for Contraceptive Use

2009-present Operating Room Diversity and Professionalism Committee at Johns Hopkins Bayview Medical Center 2009-present Membership Committee, The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2009-present Research Committee, Association of Metabolic and Bariatric Surgery (ASMBS)

2012-2013 Venous Thromboembolism Prevention Committee – Johns Hopkins Bayview Medical Center

Awards and Honors:

1986 Prudential Insurance Company Four Year College Scholarship for Academic Excellence 1986 Ontario Provincial Scholarship Award for Academic Achievement

1995 University of Toronto: Innis College Scholarship Fund for Excellent Academic Achievement 1995 University of Toronto: Award for Outstanding Academic Performance

1997 Distinguished Scholar and Class Valedictorian, GPA 4.0, Ross University School of Medicine 2001 Peace Tree Book Honor Award for Excellence in Patient Care, Penn State Hershey Medical Center 2002 Resident Physician Humanitarian Award-Jane Witmer Kienle, MD, Penn State Hershey Medical Center 2002 Member of the Penn State Pediatric Heart Surgical Team who traveled and operated with Dr. John L Myers,

Variety Children’s Lifeline, Hospital de Ninos, Dr. Roberto Gilbert, Quayaquil, Ecuador

2003 Resident Case Study Challenge Winner Year 3 Penn State College of Medicine Surgical Residents 2006 Nominated for Association of Women Surgeons Female Surgical Resident of the Year

2008 The Johns Hopkins Bayview Medical Center Shining Star Award-for outstanding clinical care

2011 Outstanding Faculty Teacher: Surgical Clerkship Teaching Award - The Johns Hopkins University School of Medicine

2012 Clinician Scientist Award - The Johns Hopkins University School of Medicine.

2103 Clinician Scientist Award – Renewal, The Johns Hopkins University School of Medicine.

2104 The American Metabolic and Bariatric Surgery (ASMBS) Excellence in Nutrition Award 2014, Annual ASMBS Meeting, Boston MA.

C. Contribution to Science

During my tenure at Johns Hopkins my main research focus has been on the gut-brain axis and its relationship to obesity. As well, I am involved in over 17 various protocols in collaboration with a diverse group of investigators all interested in obesity and its related diseases. These projects range from novel methods to treat obesity and its complications, deep venous thrombosis management in the morbidly obese, bariatric surgical outcomes and surgical education projects.

NOTES and Surgical Devices

Working with the our gastroenterology colleagues, we have been interested in finding new and novel techniques that require less invasive approaches to diagnostic testing, surgical innovations and treatments in the morbidly obese. As first author, I was involved in demonstrating a novel technique in obtaining liver samples via a transgastric approach. As well, utilizing a transoral approach we were able to demonstrate successful closure of gastrogastric fistula. In 2011, I worked with our bariatric fellow to develop a technique for successfully closing internal hernia defects using a single incision approach.

1. Steele KE, Schweitzer MA, Lyn-Sue J, Kantsevoy SV. Flexible Transgastric Peritoneoscopy And Liver Biopsy: A

Feasibility Study In Humans. Gastrointestial Endoscopy, 2008 Jul; 68. (1):61-6.

2. Steele KE, Mitchell M, Okolo P, Schweitzer M. Transoral Endoscopic Closure of a Gastric Fistula. Surgery for Obesity and Related Diseases: Official journal of the American Metabolic and Bariatric Surgery 2009; 5(2):283-4.

3. Tymitz K, Steele KE, Schweitzer M. Laparoscopic single-incision repair of internal hernia defects using an

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VTE in the Bariatric Surgical Patient

In 2014, I graduated from the Johns Hopkins Bloomberg School of Public Health with a Ph.D. in Graduate Training in Clinical Investigation. My thesis work was entitled: Venous Thromboembolism Prevention in the Bariatric Surgical Patient: Are we doing enough? This work included two retrospective cohort studies, a systematic review and meta-analysis and randomized double blinded clinical trial in which we demonstrated that fondaparinux (5mg a single dose drug) was as effective as lovenox (40 mg twice daily) in the prevention of VTE in the morbidly obese.

1. Steele KE, Schweitzer M, Shore A, Makary M, Nguyen H, Lidor A, Prokopowicz G, Magnuson T. Long-term Risk of

Venous Thromboembolism Following Bariatric Surgery. Obesity Surgery. 2011 Sep; 21(9):1371-6.

2. Steele KE., Canner J., Prokopowicz G., Verde F., Beselman A., Wyse R., Chen J., Streiff M., Magnuson T., Lidor A., Schweitzer MA.; The EFFORT Trial - Preoperative Enoxaparin versus Postoperative Fondaparinux For

Thromboprophylaxis in Bariatric Surgical Patients: A randomized double-blind pilot trial. Surgical Obesity and Related

Diseases (SOARD) (accepted October 2014 in press)

3. Abdalla G, Mathuk R, Verde Franco, Volyapul V, Magnuson T, Schweitzer M, Steele KE. The Diagnostic Accuracy of

Magnetic Resonance Venography in the Detection of Deep Venous Thrombosis: A systematic review and meta-analysis.

Clinical Radiology 2015 (Accepted March 2015, in press)

Outcomes in Bariatric Surgery

While many of my projects have concentrated on translational research and clinical trials, I have also been involved (as first author, co-author and senior author) in multiple retrospective and outcomes projects ranging from suboptimal weight loss predictors, complications of obesity surgery in Type II Diabetics, the effect of obesity surgery on health care utilization and costs among diabetics, to the effect of mandatory centers of excellence on patient outcomes.

1. Melton-Meaux GB, Steele KE, Schweitzer MA, Prokopowicz GP, Lidor AO, Magnuson TH. Suboptimal weight loss after

gastric bypass surgery: correlation of demographics, co-morbidities, and insurance status with outcomes. Journal of

Gastrointestinal Surgery, 2008, 12 (2): 250-255.

2. Steele KE, Prokopowicz GP, Chang H, Richards T, Clark J, Weiner J, Bleich S, Wu A, Segal J. Risk of Complications

after Bariatric Surgery Among Individuals With and Without Type 2 Diabetes Mellitus. Surgical Obesity and Related

Diseases. 2012 May-Jun;8(3):305-30. Epub 2011 Jun 15.

3. Bleich S, Chang H, Steele KE, Segal J. Impact of Bariatric Surgery on Healthcare Utilization and Costs among Patients

with Diabetes. Medical Care. 2012 Jan;50(1):58-65.

4. Bae, J, Shade J, Abraham A, Eric Schneider, Schweitzer M, Magnuson T, Steele KE. Effect of Mandatory Centers of

Excellence on Demographic Characteristics of Patients Undergoing Bariatric Surgery. JAMA Surg 2015 (in press) Surgical Simulation and Education

I have always been interested in surgical education and simulation as I have a love for teaching. I was the Associate Director of the Johns Hopkins Surgical Clerkships for 5 years. Presently, I am the Director of Surgical Education and Simulation on the Johns Hopkins Bayview campus and developed a surgical curriculum utilized by the Hopkins and Duke University Surgical Residency Programs. I have been working with our surgical residents and medical students on determining the effect of warm-up on surgical performance and outcomes.

1. Moran-Atkin, Abdalla G., Chen G., Lidor A., Schweitzer M., Magnuson T., Steele KE. Pre-operative Warm-p The Key to

Improved Resident Technique: A randomized study. Surg Endosc 2015 May; 29 (5):1057-1063.

2. Abdalla G., Moran-Atkin E., Chen, G., Schweitzer M., Magnuson T., Steele KE. The effect of warm-up on surgical

performance: A systematic review. Surgical Endoscopy (accepted August 2014 in press)

Finally, I have had the honor and opportunity to be an invited critique for various manuscripts in well-established surgical journals and have authored a monograph on behalf of the American College of Obstetrics and Gynecologists.

Invited Critique & Editorials

1. Steele KE. Hospital Complication Rates with Bariatric Surgery in Michigan Centers of Excellence: The Emperor’s New Clothes? Archives of Surgery, Arch Surg. 2011; 146(3):254-255.

2. Steele KE. Recent National Trends in the Use of Adolescent Inpatient Bariatric Surgery, 2000 through 2009:

Childhood Obesity, An American Epidemic: When is surgical intervention appropriate? JAMA Surg. 2013; 148(4): 314-315.

Monographs

1. Steele KE, Burke A. American College of Obstetricians and Gynecologists (ACOG) - Clinical Updates in Women's Health Care. Weight Loss Surgery and Obesity. Vol. XI, No. 1. April 2013

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URL to a full list of published work:

http://scholar.google.com/scholar?hl=en&q=kimberley+Steele&btnG=&as_sdt=1%2C21&as_sdtp=

D. Research Support

Ongoing Research Support

American Society for Metabolic and Steele PI 07/01/2014 - 06/20/2016

Bariatric Surgery Grant

Neurochemical Changes Induced by Bariatric Surgery: The Gut-Brain Axis and its Relationship to Weight Loss.

Patients will be given a meal test before and following bariatric surgery and gut hormones, systemic inflammatory markers and the microbiome will be analyzed. Patients will also under an fMRI paradigm related to the test meal given.

Role: Project Director

DK100559-01A1NIH Steele PI 10/01/2014 - 10/01/2018

Neurobiologic Alterations in Bariatric Surgery: Taste responsiveness and weight loss

The goal of this study is to determine the changes in taste responses that occur following a weight loss intervention (Vertical Sleeve Gastrectomy, Roux-en Y Gastric Bypass and Diet-induced weight loss

Role: Project Director

Neural Brain Research Unit (NBRU)

Johns Hopkins University School of Medicine Steele PI 09/01/2015 – 10/01/2018

Neurobiologic Alterations in Bariatric Surgery: Taste responsiveness and weight loss

Awarded additional funding to cover the costs of the fMRI scans for this project as stated above.

Completed Research

Association of Women Surgeons Steele PI 07/01/2006 - 06/30/2007

Grant Award

Central brain dopamine receptor activity in obese subjects before and after Roux-en Y gastric bypass surgery

Intra-departmental Young Steele PI 01/01/2008 - 06/30/2011

Investigators Award

Association of Taq 1 A1 Allele with Suboptimal Weight Loss in Obese Patients Undergoing Roux-en-Y Gastric Bypass. Patients tested for the presence of the A1 allele, and also assessed for the amount of weight loss between preoperative and 2-year postoperative visits.

Investigator Initiated Grant (GSK) Steele PI 01/01/2009 - 12/01/2013

A RCT (pilot study) to determine the feasibility of conducting a RCT comparing fondaparinux sodium once daily with enoxaparin twice daily with respect to preventing venousthromboembolism (VTE) after bariatric surgery. MRV will be used to examine the 2 week postoperative patient for VTE.

5KL2RR025006NIH Steele PI 07/01/2011 - 05/31/2013

Clinical Scholar Award (KL2)

The Johns Hopkins University School of Medicine

Completed my PhD at the Johns Hopkins Bloomberg School of Public Health in Graduate Training and Clinical Investigations. June 2014.

Clinician Scientist Award Steele PI 07/01/2013 – 06/30/2015

The Johns Hopkins University School of Medicine

Neurobiologic Alterations in Bariatric Surgery: Taste Response and Weight Loss

The goal of this study is to better understand the mechanisms responsible for weight loss after bariatric surgery by assessing the effect of bariatric surgical procedures on taste preferences and activation of brain reward systems as assessed by functional magnetic resonance imaging.

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12 Participation in SAGES

As a member of SAGES since 2005, Dr. Steele has been active in promoting and recruiting new members to the society, including Johns Hopkins surgical residents, Ob/Gyn residents, and medical students. She has also been an active member on the Membership Committee since 2007. She has authored and presented multiple

abstracts and video presentations at the SAGES conferences. She is also published in the SAGES official journal Surgical Endoscopy.

References

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