Obesity Research Abstracts

The following abstracts were presented during the poster session at Overcoming Obesity 2016 in Chicago. Looking to submit a clinical obesity research abstract? Find out if we are currently accepting abstracts for the fall conference.

Obesity Metabolic Comorbidities with Associated Disease Burden in Children and Adolescents

POSTER CONTEST WINNER!

Authors: Valerie O’Hara, DO; Nancy Browne, PNP, FAANP; Samreen Fathima, BDS, MPH; Starr Johnston, RN; Kathrin Hastey, FNP; Barbara Sorondo, MD, MBA; Janet Bayleran, PhD

Introduction: Limited data exist describing demographics, weight categories and disease burden in youth with overweight and obesity.

Aim: To study the prevalence rates of obesity metabolic comorbidities and disease burden in 2-18 year olds referred to WOW: a pediatric multidisciplinary weight management program using BMI% and obesity class.

Methods: Demographics, anthropometric measures, laboratory values collected at baseline in 383 children referred to WOW participating in IRB-approved protocol. Descriptive statistics based on the percentage of the 95th%ile & stratification analyses based on age, gender and initial BMI percentiles were conducted.

Results: 383 youth enrolled; 6% 2-5 years, 56% 6-11years, 24% 12-14 years, 14% 15-18 years. 15.4% overweight; 19.6% obesity Class I; 35.5% severe obesity Class II; 29.5% severe obesity Class III. Insulin: 42.3% of 281 children abnormal fasting insulin; 24.4% pre-diabetes per impaired fasting glucose and/or elevated HbA1c levels. Vitamin D: 71.2% of 281 insufficient or deficient. Triglycerides: 71% of 352 borderline or high; Cholesterol: 42% of 324 borderline or high; HDL: 54% of 319 borderline or low; LDL: 29.3% borderline or high. Abnormal insulin: 9% 2-5 years, 32.7% 6-11 years, 60.9% 12-14 years, 63.2% 15-18 years. Abnormal HbA1c: 16.8% 6-11 years, 15.9% 12-14 years, 11.4% 15-18 years. Abnormal LDL: 45.5% 2-5 years, 47.7% 15-18 years. Abnormal cholesterol: 58.4% 2-5 years. Abnormal triglycerides: 69% 2-5 years, 72% 6-11 years, 72% 12-14 years, 78% 15-18 years.

Conclusion: Children with BMI > 95th percentile in each age category (including 2-5 year olds) present with significant disease burden, particularly hyperinsulinemia, hypertriglyceridemia, and Vitamin D deficiency. Data highlight the existing (not “at risk for”) abnormal laboratory data/disease burden in pediatric patients with obesity presenting to WOW. Providers caring for children > 95th percentile should consider laboratory assessment for specific obesity related comorbidities and earlier referral to higher intensity interventions.

The Need for Education on Overweight and Obesity

Authors: Bradley Tanner, MD; Karen Rossie, DMD, PhD; Mary P Metcalf, PhD, MPH, CHES

Introduction: To address the obesity epidemic physicians must be ready, willing and able to assist patients. Understanding their actual and perceived needs and barriers is essential.

Methods: With support from the NIH we conducted a series of physician surveys to assess interest and need for obesity medicine education. In the surveys, physicians who had self-referred to a course on obesity medicine were asked about current practice and attitudes.

Results: Only 56% of 33 physicians reported entering a diagnosis of obesity in the medical record for patients who are obese and only 52% tell all their patients their diagnosis. Only 15% measure waist circumference in their obese patients. Respondents have little time for counseling interventions; 63% have less than 5 minutes available.

In a survey of 139 physicians 24% were either doubtful of the value of obesity interventions or saw “some value.” Only 20% said that interventions would help or provide “enormous benefit” to almost all patients. When asked about their understanding of biological topics including gut hormones, CNS transmitters, and biological mechanisms 59% rated understanding as “very low” or “fairly low”, although 72% noted that such knowledge was “important” or “very important.” When asked about their confidence in skills related to evaluation, counseling, treatment and referral, 56% expressed strong or some confidence. The areas of weakest confidence were in prescribing medications (37%), surgery, and behavioral support referral (22%).

Conclusion: We found limitations in physician skills, time available for obesity interventions and enthusiasm for the value of interventions. Respondents recognized weaknesses in their understanding of the biology of obesity and saw value in improving. Confidence was high except for typical medical tasks (medications, surgical referral). Efforts to address the educational need would benefit from focusing on the biology and science of obesity. Education should account for the very limited time available and focus on skills development rather than confidence.

Reduction in the Risk of Developing Type 2 Diabetes with Liraglutide 3.0 mg in Individuals with Prediabetes and Obesity or Overweight from the SCALE Obesity and Prediabetes Randomized, Double-blind, Placebo-controlled Trial

Authors: Carel le Roux, MBChB, MSc, FRCP, FRCPath, PhD; Arne Astrup, MD, DMSc; Ken Fujioka, MD; Frank Greenway, MD; David CW Lau, MD, PhD, FRCPC; Luc Van Gaal, MD, PhD; Rafael Violante Ortiz, MD; John PH Wilding, DM, FRCP; Trine V Skjøth, MD; Jason Brett, MD; Xavier Pi-Sunyer, MD, MPH

Background: The 3-year part of this trial investigated the effect of liraglutide 3.0 mg, as an adjunct to diet + exercise, in delaying onset of T2D (primary endpoint) in adults with prediabetes and obesity (BMI ≥30 kg/m²) or overweight (≥27 kg/m²) with comorbidities.

Methods: Participants were randomized 2:1 to once-daily subcutaneous liraglutide 3.0 mg or placebo plus 500 kcal/day deficit diet and 150 min/week exercise. Efficacy data are observed means, with last observation carried forward for missing values. Clinicaltrials.gov ID: NCT01272219.

Results: Of 2254 randomized individuals with prediabetes (age 47.5±11.7 years, 76.0% female, weight 107.6±21.6 kg, BMI 38.8±6.4 kg/m2, mean±SD), 1128 completed 160 weeks (52.6% on liraglutide, 45.0% on placebo). At Week 160, mean weight loss (WL) was 6.1% with liraglutide vs. 1.9% with placebo (estimated treatment difference -4.3% [95%CI -4.9;-3.7], p less than 0.0001). More individuals achieved ≥5% WL (estimated odds ratio [OR] 3.2 [2.6;3.9]) receiving liraglutide vs placebo (49.6% vs 23.7%) and more achieved >10% WL (OR 3.1 [2.3;4.1]) (24.8% vs 9.9%), both p less than 0.0001. Based on the Kaplan-Meier plot of cumulative probability of a diagnosis of diabetes taking censoring into account, 3% of individuals in the liraglutide group vs. 11% in the placebo group were diagnosed with diabetes by week 160 while on treatment. At week 160, the estimated time to onset of diabetes was 2.7 times longer with liraglutide than with placebo while on treatment (95% CI 1.9; 3.9, p less than 0.0001), corresponding to a hazard ratio of 0.2. Liraglutide was generally well tolerated. Gallbladder-related events (2.9 vs 1.2/100 patient-years of observation [PYO]) and confirmed pancreatitis (0.29 vs 0.13 events/100 PYO) were low, but more frequent with liraglutide.

Conclusion: Liraglutide 3.0 mg, plus diet + exercise over 3 years was associated with greater weight loss and reduced risk of T2D compared to placebo. This abstract has been supported by Novo Nordisk.

Divergence of Patient and Clinician Perceptions of Obesity and Weight Management

Authors: Lee M Kaplan, MD, PhD; Angela Golden, DNP, FNP-C, FAANP; Patrick O’Neil, MD; Joseph Nadglowski; Theodore Kyle, RPh, MBA; Ronette L Kolotkin, PhD; Michelle Look, MD, FAANP; Ching Lum; Morten Donsmark, PhD; Nikhil Dhurandhar, PhD

Background and aim: Obesity is a chronic disease associated with significant morbidity, for which few affected individuals receive adequate medical care. The ACTION (Awareness, Care & Treatment In Obesity MaNagement) study was designed to identify barriers reported by people with obesity (PWO) and clinicians that may hinder the initiation of such care.

Material and methods: Focus groups including 43 PWO (class I: N=14; class II: N=13; class III: N=16) and individual interviews with 24 clinicians (12 primary care providers and 12 obesity specialists) were conducted, transcribed, and coded thematically.

Results: In total, 75% of PWO perceived themselves as ‘healthy’, although nearly three-quarters had obesity-related comorbidities. While PWO and clinicians considered obesity a combination of disease and lifestyle, their primary emphases differed widely; 65% of PWO considered obesity primarily a lifestyle issue, and 88% of clinicians considered it a disease. Motivation was perceived as a key barrier to weight loss by both PWO and clinicians (77% vs. 75%, respectively); limited patient understanding of their condition less so (35% vs. 42%). Relative to clinicians, PWO more often cited barriers of food habits (88% vs. 38%), social relationships (79% vs. 38%) and feeling deprived while dieting (56% vs. 8%), and less often cited limited patient understanding of how to lose weight (9% vs. 58%). Importantly, PWO indicated that developing health complications or receiving a ‘wake-up call’ in relation to their health would motivate them to address their obesity.

Conclusions: Perceptions of obesity appear to vary between PWO and clinicians. This discordance may be a barrier to effective communication and treatment, and thus contribute to suboptimal patient-clinician interactions. This qualitative association provides the basis for quantitative examination of these perceptions and their causes, the understanding of which could enhance patient-clinician collaboration in the treatment of obesity. This abstract has been supported by Novo Nordisk.

Demographics of Women Whose Macrosomic Infants are Admitted to the Neonatal Intensive Care Unit

Authors: Darlene A. Calhoun, DO; Jose N. Tolosa, MD

INTRODUCTION. Nearly half a million macrosomic infants are born each year in the United States-a number comparable to the number born prematurely. While macrosomia-associated risk factors with maternal diabetes have been well studied, little information is known about mothers whose macrosomic infants require NICU admission.

OBJECTIVES. We proposed to determine the: 1) number of deliveries ≥ 4000 grams from 1/01/2010- 12/31/ 2015, 2) number of deliveries of infants ≥ 4000 grams requiring NICU admission, and 3) maternal demographics for all mothers whose infant was admitted to the NICU.

METHODS. A retrospective review of maternal charts involving the delivery of an infant ≥ 4000 grams was performed from 1/01/2010-12/31/2015. IRB approval was obtained for the study. Maternal information included: history of diabetes, maternal pre-pregnancy BMI, maternal weight gain during pregnancy, mode of delivery, race, and grade of infant macrosomia.

RESULTS. 19,308 deliveries occurred in the six year period, and 1859 (9.6%) were infants ≥ 4000 g. The number of macrosomic infants increased 39% in 2014-2015 compared to 2010-2013. Of these, 213 infants were admitted to the NICU, representing 7.8-11.3% of NICU admissions. The majority (74%) were Grade I macrosomia and most (62.9%) were male. Cesarean section delivery occurred in 63% of these cases compared with a baseline hospital rate of 31%. Most mothers were Caucasian (59.6%) and did not have diabetes (69%). While 34.7% of these mothers had a normal pre-pregnancy BMI, 63.7% were classified as either overweight or obese. Nearly half (47.7%) of mothers gained more weight than recommended, and a greater number of these women had normal (38.8%) or overweight (28.8%) pre-pregnancy BMI.

CONCLUSIONS. Maternal pre-pregnancy obesity and excessive weight gain during pregnancy are increased in mothers whose macrosomic infants require care in the NICU. The majority of these mothers did not have diabetes. Because a significant number of macrosomic infants require NICU admission, further studies are warranted to assess risk factors.

The C3-convertase Stabilization among Patients with Abdominal Obesity

Authors: Eliashevich S.O., MD; Drapkina O.M., MD, PhD; Shoibonov B.B., MD, PhD

Background: The abdominal obesity is associated with a low-grade chronic inflammatory status, to which the complement system is an important contributor. In several reports, C3 and the degree of C3 activation (C3a and C3a-desArg) have been linked to diabetes and cardiovascular disease (CVD). However, the studies of C3-convertase functional activity haven’t been taken yet.

Aim: To evaluate the C3-convertase stabilization of the classical pathway of complement system activation in middle-aged individuals with abdominal obesity at low cardiovascular risk.

Patients and methods: A pilot study, including 45 patients without evidence of atherosclerosis at low CVD risk according to SCORE, was designed. Abdominal obesity was detected by IDF criteria. All patients underwent a comprehensive clinical evaluation with lipid profile, including the cholesterol of modified LDL (mLDL-C) level, and glucose analyzes. The C3-convertase functional activity (%) – a key enzyme complex of the classical pathway complement activation, were assessed by using original techniques.

Results: Analysis included 45 participants (mean age: 41(9) years; body mass index: 27(5) kg/m2; and 47% male). Mean lipid values were as follows: total cholesterol: 5.4 (1) mmol/l; LDL-C: 3.8 (1) mmol/l; HDL-C: 0.98 (0.3) mmol/l; triglycerides 2.5 (1.5 – 2.1) mmol/l. 27 (60%) participants of the sample had signs of abdominal obesity. Among them 41 % (11) with overweight, 44 % (12) with obesity. There were found significant differences in the mLDL-C level of patients with abdominal obesity and without it (p less than 0,01): 1.2 mmol/l (0.8 – 1.4) and 0.7 mmol/l (0.6 – 0.9),accordingly (p less than 0,01). The activity of stabilized C3-convertase was high (mean 18.5 (7.6)%) in the majority of patients (82%), independently of BMI, waist circumference, blood pressure and lipid variables. Conclusion: The observed fact of C3-convertase stabilization, apparently, can serve as a predictor of the autoimmune nature of abdominal obesity.

Thyroid Treatment in Weight Loss Patients: Ecological Physiology Provides a New Paradigm

Authors: Carol N. Rowsemitt, PhD, RN, FNP; Thomas Najarian, MD

Chronic decreased metabolism occurs in weight loss. Current thought on thyroid fails to understand this condition. Evaluation is primarily with thyroid stimulating hormone (TSH); treatment is with levothyroxine (T4). We explain why both are wrong for most weight loss patients. Viewing the hypothalamic-pituitary-thyroid axis as having a stable set point is a mistake. Eco-physiological studies inform us that animals evolved to adjust to environmental changes. Feedback loop set points change to achieve these adaptations. Most studied is seasonal breeding: e.g., adult male hamsters basically undergo puberty every spring, and reverse the process every fall. Higher levels of testosterone are needed to suppress gonadotropin secretion in summer than in winter, proving a set point change. In humans, dieting lowers the set point for the active thyroid hormone, liothyronine (T3), so the hypothalamus redefines the range of normal free T3 to be at a lower level than when well-fed. When a patient presents with symptoms of low thyroid and a weight-loss plateau despite appropriate behaviors, but has normal TSH, most clinicians conclude the thyroid is fine. But free T3 is often at the low end of normal or the ratio of free T3/reverse T3 is low. (Reverse T3 either decreases metabolism or is a marker for decreased metabolism.) In either case, treatment with a source of T3 returns T3 to mid- or high-normal. Hypothyroid symptoms resolve, and weight loss restarts. Yet TSH is zero due to the decreased set point. The patient is hyperthyroid in one measure only: TSH. Most providers would conclude the patient is hyperthyroid and discontinue T3, resulting in recurrence of hypothyroid symptoms and plateau. Treating with T4 will fail, as T4 does not increase T3 in the famine state. Understanding this framework leads us to focus on symptoms and thyroid hormone levels. While many questions remain, failure to recognize the eco-physiological changes in the famine response may be dooming many patients to only a 10% weight loss with possible regain even while continuing a low calorie diet.

Projecting Adulthood Perceived Psychosocial Variables and Health Behaviors from Childhood Experiences: Focus of African-American College Students

Author: Katherine Fickert

In order to properly inform caregivers how to set their children up for a healthier lifestyle, we must know how and where to place emphasis. The current study examines the attributes from childhood that may carry over into adulthood, which may help the adult make healthier choices. The current study will look into social and familial support, as well as education, and proximity to food deserts. It will focus on how all these effect the person’s perceived competence and self-efficacy in diet and exercise. The students were recruited from numerous classes around campus in which they gave the researchers an email address. Jackson State University, given IRB approval, also supplied the researcher with a list of current undergraduate email addresses. The survey was then distributed via Qualtrics Survey Software to each person who on the email list. There were a total of 41 individuals whom completed the survey, all of which were required to be collegiate African-Americans. The data was then analyzed using IBM’s Statistical Package for the Social Sciences (SPSS), 23rd version. According to SPSS, there is a negative correlation between discouragement from family and the participant’s self-efficacy for exercise both with ability to stick with it and time commitment. There was a positive correlation between discouragement from family and feeling confident the individual could control calorie intake. The data indicates that the higher the level of perceived competence, the more active the individual. The data also indicates a higher level of perceived competence with a healthy diet, the healthier their diet actually is. One indication that can be made from the data is that there may be no relationship between having a health class (whether it emphasizes healthy diet or exercise) and having healthy habits as an adult. These findings indicate that there needs to be further investigation between psychosocial variables and health behaviors. Moreover, research is needed in this area to bridge the gap of what happens in childhood and how it may affect an individual.

Comparison of Clinical Outcomes among Insured and Self-financed Patients with Obesity in a Non-surgical, Medically Supervised Weight Loss Program: A Retrospective Cohort Study

Authors: Macklin Guzman, DHSc, MPH; Kumudini Sagi, MPH; Sara VanWyk, MPH, CCRP; Edward Zbella, MD; Sejal Shah Alvarez, MD

Introduction. Research suggests that health insurance coverage increases participation in weight loss programs and may improve health outcomes; however, limited evidence exists on the health impact of commercial health insurance status among obese patients enrolled in a medically-supervised weight loss program.

Methods. A retrospective cohort study (N=1,233) was performed over a 16-week period. Inclusion criteria: starting BMI ≥30, age ≥18 years, and site visits ≥2. Patients were categorized by insurance status: insured (n=301); self-financed (n=932). Parameters evaluated: changes in total body weight, body composition, BMI, blood pressure, and total site visits. To assess the differences between study groups, T-test and Mann-Whitney U tests were used for continuous variables and chi-square test was used for categorical variables. Multiple linear regression was used to evaluate predictors of weight loss and Cox proportional hazard model was used to examine the impact of insurance on weight loss.

Results. Univariate analysis revealed that insured patients had more median (Mdn) site visits (12vs.10,P=0.001), total Mdn days in the program (73vs.63,P=0.001), greater decrease in both systolic (-4mmHg,P=0.746) and diastolic (-4mmHg,P=0.032) Mdn blood pressure compared to self-financed group (-2mmHg). Self-financed patients lost more Mdn body weight (-7.2kg vs.-5.8kg,P=0.000) and showed increased reduction in Mdn body fat percentage (-2.5%vs.-2.0%,P=0.026). Regression analysis revealed that initial weight and longer program duration independently predicted weight loss (P less than 0.05). Sensitivity analysis showed that insured patients were 27% less likely to lose weight compared to the self-financed group (Hazard ratio =0.73; 95% CI:0.63-0.83).

Conclusion. The findings suggest that self-financed patients have better weight loss outcomes with fewer visits compared to insured patients. However, given the relative proximity of some outcome measures, the degree of clinical relevance should also be considered despite statistical significance.

Vitamin D Deficiency and Pubertal Status are Associated with Markers of Insulin Resistance in Pediatric Patients with Overweight and Obesity

Authors: Marisa Censani MD, Dipl. ABOM; Tiffany Schumaker, DO; Hoda T Hammad MS, MPH

Introduction. Obesity is a risk factor for vitamin D deficiency. Serum 25-hydroxyvitamin D (25OHD) levels are inversely related to BMI. There is scarce and conflicting data regarding influence of puberty on vitamin D status; the relationship of 25OHD and markers of cardiometabolic risk in pubertal and prepubertal patients is not delineated. Our aim was to examine the relationship between 25OHD, puberty, and markers of abnormal glucose metabolism and metabolic syndrome.

Methods. A cross-sectional analysis of 332 patients, age 6-17 years, seen at Weill Cornell Medicine between 4/2013 and 5/2015 with 25OHD levels obtained. Age, gender, and pubertal stage (Tanner 1-5) and markers of cardiometabolic risk were collected.

Results. 178 of 332 patients (61 boys and 117 girls; age: 12.1±3.3 years; BMI:28.9±8.8 kg/m2) met criteria for overweight and obesity (BMI>85th percentile). Mean vitamin D level was statistically different between pubertal and prepubertal groups (20.3±8.6 vs. 23.45±9.3 respectively; p=0.03) and significantly higher in those at Tanner 1 (23.2±9.7) vs. Tanner 5 (19.5±7.3) (p=0.02). 25OHD was associated inversely with BMI (p less than 0.0001), age (p=0.0002), fasting insulin (p less than 0.05), total cholesterol (p less than 0.05) and triglycerides (p less than 0.02) with HOMA-IR (p=0.07) and HbA1c (p=0.06) approaching significance. In patients with fasting metabolic parameters (n=82), puberty was associated with greater degree of insulin resistance, with fasting insulin and HOMA-IR statistically higher in pubertal than prepubertal subjects (p less than 0.0001).

Conclusion. Vitamin D deficiency was significantly associated with cardiometabolic risk factors. Findings suggest that deficiency may have negative effects on insulin sensitivity. Pubertal status and more specifically advanced stages of puberty (Tanner 5) may be risk factors for deficiency and overall lower vitamin D levels, and appear to play a role in the degree of insulin resistance. This study highlights the role of 25OHD level monitoring in pediatric patients with obesity and the possible need for increased supplementation during puberty.

Comparable Efficacy and Safety of Liraglutide 3.0 mg across Baseline BMI Subgroups

Authors: Ralph DeFronzo, MD; Gabriella Lieberman, MD; Søren Kruse Lilleøre, MSc; Jason Brett, MD; Sten Madsbad, MD, DMSc

Aims: The 3-year part of the SCALE Obesity and Prediabetes trial examined effects of liraglutide 3.0 mg, as adjunct to diet and exercise, in delaying the onset of type 2 diabetes (primary endpoint) in adults with prediabetes and BMI ≥30 kg/m2, or ≥27 kg/m2 with comorbidities. Here we evaluate glycemic control endpoints and safety in BMI subgroups post hoc.

Methods: Individuals randomized 2:1 to once-daily s.c. liraglutide 3.0 mg or placebo, with a 500 kcal/day deficit diet and 150 min/week exercise, were divided into baseline BMI subgroups: 27–29.9 (n=62), 30–34.9 (n=624), 35–39.9 (n=737) and ≥40 kg/m2 (n=831). Efficacy data are from an ANCOVA, with LOCF imputation. Clinicaltrials.gov ID: NCT01272219.

Results: Baseline characteristics of 2254 randomized individuals were (mean±SD): age 47.5±11.7 years, 76.0% female, weight 107.6±21.6 kg, BMI 38.8±6.4 kg/m2, A1C 5.7±0.3%. A Kaplan-Meier plot (accounting for censoring) of the cumulative probability for a diabetes diagnosis showed 3% of patients on liraglutide vs. 11% on placebo were diagnosed with diabetes by week 160 while on treatment. No significant interactions between treatment and baseline BMI subgroup were seen for weight or glycemic control endpoints, interaction p values were: body weight (%), p=0.48; body weight (kg), p=0.97; A1C (%), p=0.06; FPG (mmol/L), p=0.55; fasting insulin (% relative change), p=0.31; HOMA-B beta-cell function (% relative change), p=0.50; HOMA-IR insulin resistance (% relative change), p=0.59; 2-h oral glucose tolerance test (plasma glucose, area under the curve, h*mmol/L), p=0.97; proportion (%) individuals with normoglycemia, p=0.92, revealing a consistent treatment effect of liraglutide 3.0 mg across subgroups. Total and serious adverse events, gastrointestinal and hypoglycemic events had similar incidences across BMI subgroups.

Conclusions: Liraglutide 3.0 mg, as adjunct to diet and exercise, consistently improved glycemic control endpoints and beta-cell function, and enhanced insulin sensitivity across BMI subgroups. This abstract has been supported by Novo Nordisk.

The Best Fast Mediterranean Diet, a Modified American Style

Authors: Saad Sakkal. MD; Luna Sakkal,RD; Maysa Mounla-Sakkal; Mohamed Loutfy Sakkal

Introduction: Mediterranean Diet is established as proven successful for brain, heart and metabolic health. It improves cardiovascular risk factors/events, atherosclerosis, DM, and obesity. Intermittent Fasting improves metabolic parameters, weight loss, and Telomere length with longevity benefits. We tested impact of adding both in medical obesity program, and pre-bariatric surgery in a version adaptable to American Style.

Methods: we summarize the results of 200 patients treated. Average age was 40 years, F128/M72, Metabolic Syndrome 181, Diabetes 82, Prediabetes 104, Hypertension 102, prehypertension 76, Hyperlipedemia168. Lifestyle changes: include relaxation, sleep hygiene, pollution/smoking free and treating psychosocial dysfunction. Diet: Real fresh food, in smaller portions, mostly plants based anti- inflammatory, low glycemic index, low salt, natural, high fiber, and healthy fat. It include Daily: 4-12 cups of water, 4-12 nuts/seeds, 4 fruits and vegetables, and one serving of yogurt, olive oil, plant protein and 3 omega tablet; Weekly 4 eggs, seafood, and dairy , 2 turkey and chicken; Monthly red meat and sweet if weight goals are accomplished. We advise reasonable avoidance of: sugar, salt, sweet, soft drinks, snacks, and stuffs that are fried. Fasting: 12 hours or more based on tolerance, two days weekly, break the fast on water and fruit first, followed by vegetable, protein (plant or meat), followed by starch only at the end of the meal if still hungry. A small CHO free snack is the other meal fo fasting day. We check ketones.

Results: Compared to low fat or CHO diets: At 6 months: average weight loss was 18.4 Lbs., low fat diet 10 Lbs., low CHO of 14.6.At one year maintenance of weight was even better: Mediterranean with fasting 26 lbs., low fat 8.4 lbs., and low CHO 17.2 lbs.

Conclusion: Modified Mediterranean Diet-American style seems as good as or better than Low CHO, low fat, and standard Western Mediterranean diet. It should be considered another alternative in the person with obesity treated medically or pre-bariatric surgery.

Identification of Pre-Diabetes in UAB Weight Loss Clinic

Authors: Sowmya Chandra Reddy, MD; Amy H Warriner, MD; Monica Agarwal, MD; Ivania Rizo, MD; Laura Q. Rogers, MD; Taraneh Soleymani, MD

Introduction: Prevalence of obesity, pre-diabetes and diabetes is increasing at an alarming rate. 86 million Americans now have pre-diabetes and 9 out of 10 are unaware they have pre-diabetes. Point of care (POC) hemoglobin A1c (HbA1c) testing allows for immediate access to HbA1c values during an office visit. We planned a prospective screening of patients seen at UAB weight loss clinic using HbA1c to identify the pre-diabetes group.

Methods: New patients seen at the clinic have point of care HbA1c values tested at initial visit unless a recent HbA1c is available within last 3 months. A Siemens DCA Vantage POC HbA1c machine is used for all testing.

Results: We collected data from 2014 through 2016. Overall, 49.9% (498 of 998 total tests) of HbA1c values collected in the Siemens point of care HbA1c device were 5.7% or greater. In the data obtained from the UAB electronic medical record, there were 386 unique point of care HbA1c values for new patients. Of those, 122 (31.6%) were in the pre-diabetes range (5.7% – 6.4%). The majority of the patients identified as having pre-diabetes based on POC HbA1c had not been previously identified as having pre-diabetes. Patients with HbA1c values in the pre-diabetes or diabetes categories were older (median= 53 +/- 13) than patients with normal HbA1c values (median = 44+/-14). Waist circumference was similar in patients in the pre-diabetes or diabetes categories (120+/-20 vs 123+/-15) and slightly lower among those with a normal HbA1c (109+/-18).

Discussion: Point of care HbA1c assays are a time-efficient tool for identifying persons with or at-risk of diabetes during an office visit. It is especially important for identifying and treating people with pre-diabetes who would otherwise go unrecognized. By screening at weight loss clinic we are able to target a high risk group.

Conclusion: POC testing is a useful tool for identifying people with pre-diabetes in a weight loss clinic at an academic medical center who are at risk of progressing to diabetes.

Exercise Testing of Children with Obesity and Severe Obesity Using the Bruce Treadmill Protocol: New Reference Values

Authors: Suzanne E. Cuda, MD; Julee A. Guinn, MS

Introduction: The Bruce protocol is used extensively in exercise studies. The original pediatric standards were published in 1978 based on 327 Canadian children 4-18 years in 6 age groups: 4-5, 6-7, 8-9, 10-12, 13-15 and 16-18. Body composition was not included but assumed normal. To date, no published standards for children with obesity exist. This study was done to establish standards.

Methods: 85 children 4-18 years with overweight or obesity were eligible. Exercise was performed on a programmable treadmill. A four lead electrocardiogram was monitored at rest and 3 minute intervals. Systemic blood pressure was obtained pre and 4 minutes post exercise. Only 4-5 year olds were allowed to hold the guardrails. Exercise was terminated when the child indicated, by holding the guardrails or verbally. Maximal effort was based on heart rate and observed exertion. Exclusions include a lack of cognitive understanding, balance instability, or lack of maximal effort.

Results: 85 children were tested: 8 16-18 year olds (yrs): 2 females (F), 6 males (M), 22 13-15 yrs: 7 F, 15 M, 37 10-12 yrs: 16 F, 21 M, 11 8-9 yrs: 8 F, 3 M, 5 6-7 yrs: 2F, 3 M, and 2 4-5 yrs: 1F, 1M. Duration was less for F than M at every age but not statistically significant. When grouped for percent body mass index (BMI), 6 children had BMIs less than the 95th percentile (overweight), 27 had BMIs between the 95th and the 119th percent (obese), 35 had BMIs between 120-149 percent (severely obese), and 17 had BMIs at 150 percent or greater (very severely obese). Overweight children achieved durations 97% of the 10th percentile published in the original standards. Obese achieved durations 75% of the 10th percentile, severely obese achieved durations 67% of the 10th percentile, and very severely obese had durations at 55% of the 10th percentile.

Conclusions: Increased BMI correlates directly with decreased performance on the Bruce protocol. This study develops a reference for assessing cardiorespiratory fitness, a predictor of early cardiovascular disease, in children with obesity.

Correlation of TGY/HDL Ration as Surrogate Testing for Elevated Fasting Insulin Levels

Author: W. Allen Rader, MD

Background: Routinely measured markers that might predict the presence of Insulin Resistance (IR) have been studied. The critical levels of insulin levels that determine probable insulin resistance and levels of normal vary between institutions and labs. Studies are published now linking the TGY/HDL directly to cardiovascular risk. Most published studies using the TGY/HDL ratio were in known diabetics. But studies are done even in health subjects. The insulin level that correlates best with Insulin resistance as compared to the HOMA-IR is debated but one study has it as low as 9

Purpose: Our goal was determine if the TGY/HDL ratio in a population of patients attending an obesity treatment clinic might predict the fasting insulin level, one of the markers of insulin resistance.

Methods: Data was extracted from the computerized records of our 4 clinics of Idaho Weight Loss and of the 2 clinics of Dr Warren Willey. Patients that had TGY HDL and fasting insulin levels obtainable from the records that sought treatment in the clinics were included. 1783 patients had data that were included in the analysis.

Main Outcome Measures: The studied lab values were collected tabulated and grouped according to TGY/HDL levels. The corresponding fasting insulin levels were tabulated and a graph generated showing the results.

Results:
Graph

Conclusions: In this time of value based medicine, using commonly obtained lab values of the TGY and HDL, calculating a ratio then using this ratio to predict the probability of the fasting insulin level being elevated has great value in a clinical practice. In our data set by the time the TGY/HDL ration reaches 3, if one uses 10 as an elevated TGY/HDL, 72% of patients seeking weight loss in our weight loss clinics have elevated insulin levels. Further studies are needed to see if this number can be used to successfully direct nutritional and medical therapy.

Relationships between Fasting Serum Amylase and Ghrelin, Peptide YY3-36 Levels in Healthy Men with Obesity

Author: Young Jin Tak, MD, PhD

Objectives: Appetite and carbohydrate metabolism are important contributors to the development of obesity. Recently, low serum amylase was shown to be associated with obesity and metabolic disorder. We investigated the relationship between amylase and ghrelin, peptide YY (PYY) levels in healthy men with obesity.

Methods: Twenty-one men with obesity were enrolled in this cross-sectional study; all subjects were asymptomatic with no medical history. Fasting serum amylase, ghrelin, PYY3-36, anthropometry and nutrition intake were measured. Linear regression analyses were performed to examine associations between amylase and ghrelin or PYY3-36.

Results: The mean age and waist circumference (WC) of the subjects were 51.5 ± 10.9 years, and 97.0 ± 4.4 cm. Amylase was found to be correlated with WC (r = -0.438, P = 0.054), ghrelin (r = 0.533, P = 0.015) and PYY3-36 (r = -0.511, P = 0.021). Multivariate linear regression analysis revealed a negative association between amylase and PYY3-36 (β = -0.428, P = 0.045), but a non-significantly positive association between amylase and ghrelin (β = 0.260, P = 0.146).

Conclusions: Amylase levels were found to be associated to ghrelin and PYY3-36 in healthy men with obesity. Amylase, ghrelin, and PYY3-36 may play role in obesity, further research is required to identify the underlying mechanism.

Dietary Supplementation of Oleoylethanolamide (OEA) Results in Weight Loss in Humans: The First-in-Human Case Studies

Authors: Belton Douglas Hallmark, MD; Kyle Rose, RD, LD; Jay N. Yepuri, MD, MS; Shashidhara Marulappa, DVM, MS, MBA

Introduction: RiduZone™ (OEA/The Product) is an FDA acknowledged, safe, new dietary supplement that support a healthy weight, appetite and body fat composition in humans. OEA produced in the small intestine and is a metabolite of dietary oleic acid. OEA is also the most potent known agonist of the PPAR-α receptor. OEA acts in the small intestine and induces satiety and stimulates lipolysis in. In animal studies oral administration of OEA resulted in weight loss, calorie restriction and serum cholesterol reduction. In humans, the amount of endogenously produced OEA from dietary precursor is insufficient to induce weight loss.

Methods: In one study, fifty (n=50) human subjects interested in losing weight were advised to take the product, 2-3 times/day, 15-30 minutes before a meal for 4-12 weeks. Subjects included those who had not used weight loss products before, those who experienced adverse events with other weight loss products, those whose weight loss plateaued on other weight loss agents such as phentermine, those trying to implement life style changes (portion control and regular exercise), and those actively being managed for medical conditions including impaired glucose tolerance, dyslipidemia, hypertension and cardiovascular diseases.

In a second study, 4 subjects with baseline weights of 229, 242, 375 and 193 lbs respectively, were instructed to take the product. Subjects took 4 capsules (1 capsule 15-30 minutes before meals and they were to take an extra capsule prior to their largest meal of the day) daily for 28 days. The last subject had previously undergone lap band placement. Subjects were instructed to make no changes to their diet and exercise habits.

Results: In the first study, subjects lost an average of 1-2 lbs/week. There were no side effects except for one patient experiencing transient nausea that was resolved in less than a week.

In the second study, 3 out of 4 subjects reported weight loss (3, 7, 15 and 0 lbs respectively). All 4 subjects reported a 10-15% decrease in portion size, prolonged inter-meal intervals, and no side effects.

Conclusion: The early first-in-human study results support the fact that the product is a safe and effective tool for calorie restriction and weight loss. Subjects with history of lap-band placement (or other bariatric procedures) may require a longer duration of treatment to experience desired weight change. Further studies with larger sample size are warranted for further confirmation.

Challenging Traditional Cardiovascular Risk Methods

Authors: Amy Savagian, MD; Jeff Gerber, MD; Ivor Cummings

Diabetes, obesity, and cardiovascular disease define the healthcare crisis of our time. In this presentation, data will be presented to show that elevated insulin levels and direct imaging are more sensitive tools to assess cardiovascular risk than traditional cholesterol panels and Framingham risk scores. Imaging and insulin levels will allow us to detect early cardiovascular disease preventing many deaths.

One of the pioneers in evaluating metabolic syndrome, Joseph R. Kraft, MD, performed over 16,000 insulin and glucose assays on patients. He was once quoted saying, “Those identified with cardiovascular disease, not identified with diabetes, are simply undiagnosed.” From Dr. Kraft’s work we should posit the theory, if there is cardiovascular disease then there is elevated insulin. The secondary research presented here involves the analysis and synthesis of dozens of studies, books and articles. The research we evaluated showed that elevated insulin levels lead to multiple metabolic effects seen in metabolic syndrome, atherosclerosis and cardiovascular disease. Elevated insulin could therefore be used as an early tool to detect cardiovascular disease. We also evaluated other tools in early assessment of atherosclerosis and cardiovascular disease. The most significant of these that was coronary artery calcium scores.

The current recommended approach to assess cardiovascular disease is a cholesterol panel with secondary questioning for risk factors. Insulin assays and calcium scores are far more sensitive tools for assessing cardiovascular risk. CAC scores and insulin levels should be used to help direct therapy. Further research is needed to show that these testing methods are superior. Given the underlying mechanisms, lifestyle changes, including low glycemic, real food nutrition plans should be a significant part of the treatment plan for cardiovascular disease.

A Structured Multicomponent Intervention Over Twelve Week Results in Significant Weight Loss in Adult Asian Indians with Obesity

Authors: Suchitra Behl, MD; Anoop Misra, MD

OBJECTIVE: To evaluate the effect of orlistat along with lifestyle modifications for twelve weeks in adult Asian Indians patients unable to lose weight through lifestyle modifications.

METHODS: Obesity was defined BMI criteria per the Consensus Statement for Asian Indians using a cut-off of ≥ 25 kg/m2. Patients with uncontrolled diabetes, acute or chronic kidney/liver disease, cardiovascular disease, heart failure, untreated endocrine disorders, pregnancy, malignancy, uncontrolled depression and excess alcohol consumption were excluded from joining the program. Body composition analysis was measured using leg-to-leg bioelectrical impedance method (TANITA MC-190, Tanita Corporation, Tokyo, Japan) in the first and last visit. The body weight was recorded at baseline, at 6 weeks and at 12 weeks. Patients were seen once a month by a physician and were advised orlistat (120mg) with every meal. They were counseled every two weeks by a trained nutritionist on hypo-caloric diet up to a minimum of 1200 kcal and moderate intensity physical activity for at least 30 min/day on all or most days of the week.

RESULTS: Ninety-three patients ( mean age 36.29 years, mean weight 91.05 kg ) joined the program out of which fifty-six patients completed twelve weeks. Analysis of the results of those who completed the program showed a mean weight loss 5.95 kg (6.3%).