Preoperative Depression Status and 5 Year Metabolic and Bariatric Surgery Outcomes in the PCORnet Bariatric Study Cohort.

OBJECTIVE: To examine whether depression status before metabolic and bariatric surgery (MBS) influenced 5-year weight loss, diabetes, and safety/utilization outcomes in the PCORnet Bariatric Study. SUMMARY OF BACKGROUND DATA: Research on the impact of depression on MBS outcomes is inconsistent with few large, long-term studies. METHODS: Data were extracted from 23 health systems on 36,871 patients who underwent sleeve gastrectomy (SG; n=16,158) or gastric bypass (RYGB; n=20,713) from 2005-2015. Patients with and without a depression diagnosis in the year before MBS were evaluated for % total weight loss (%TWL), diabetes outcomes, and postsurgical safety/utilization (reoperations, revisions, endoscopy, hospitalizations, mortality) at 1, 3, and 5 years after MBS. RESULTS: 27.1% of SG and 33.0% of RYGB patients had preoperative depression, and they had more medical and psychiatric comorbidities than those without depression. At 5 years of follow-up, those with depression, versus those without depression, had slightly less %TWL after RYGB, but not after SG (between group difference = 0.42%TWL, P = 0.04). However, patients with depression had slightly larger HbA1c improvements after RYGB but not after SG (between group difference = - 0.19, P = 0.04). Baseline depression did not moderate diabetes remission or relapse, reoperations, revision, or mortality across operations; however, baseline depression did moderate the risk of endoscopy and repeat hospitalization across RYGB versus SG. CONCLUSIONS: Patients with depression undergoing RYGB and SG had similar weight loss, diabetes, and safety/utilization outcomes to those without depression. The effects of depression were clinically small compared to the choice of operation.

Night eating, weight, and health behaviors in adults participating in the Daily24 study.

BACKGROUND: Night eating syndrome (NES) is associated with adverse health outcomes. This study evaluated the relationship between night eating severity, weight, and health behaviors. METHODS: Participants (N = 1017; 77.6% female, mean Body Mass Index (BMI) = 30.5, SD = 7.8 kg/m2, age = 51.1, SD = 15.0 years) were recruited from three health systems. Participants completed the Night Eating Questionnaire (NEQ) and questionnaires assessing sleep, chronotype, physical activity, diet, weight, and napping. RESULTS: In the overall sample, higher NEQ scores were associated with higher BMI (p < .001) and consumption of sugar-sweetened beverages (p < .001), as well as lower fruit/vegetable consumption (p = .001). Higher NEQ scores were associated with increased odds of having overweight/obesity (p < .001), eating fast food (p < .001), moderate-vigorous physical activity (p = .005), and smoking (p = .004). Participants who exceeded the screening threshold for NES (n = 48, 4.7%) reported elevated BMI (p = .014), an increased likelihood of overweight/obesity (p = .004), greater sugar-sweetened beverages consumption (p < .001), napping less than twice per week (p = .029), shorter sleep duration (p = .012), and a later chronotype (M = 4:55, SD = 2:45). CONCLUSION: Night eating severity was associated with obesity and intake of fast food and sugar-sweetened beverages. Interventions to address night eating and associated behaviors may enhance the efficacy of weight management interventions and promote engagement in positive health behaviors.

Restriction of range effects in post-metabolic and bariatric surgery outcomes research: considerations for clinical decision making.

BACKGROUND: Preoperative psychopathology does not consistently predict postoperative outcomes in patients who undergo metabolic and bariatric surgery (MBS). Individuals with elevated pre-MBS psychopathology may be less likely to undergo surgery, which may create a floor effect given the limited range of scores on measures of psychopathology included in postoperative analyses, thereby decreasing the power to detect clinically significant differences between groups. OBJECTIVES: Our objective was to compare rates of clinically significant pre-MBS psychopathology across domains of functioning in patients who did and did not undergo MBS: surgical completers (SCs, n = 286) and nonsurgical completers (NSCs, n = 125). SETTING: Academic medical center, United States. METHODS: Participants (n = 411) were a racially diverse sample of MBS candidates who completed a preoperative psychosocial evaluation including measures of disordered eating, alcohol and tobacco use, pain catastrophizing, anxiety, and depressive symptomatology. RESULTS: Compared with SCs, NSCs had larger scale score variance on measures of psychopathology and were more likely to be Black; to report clinically significant scores on measures of binge eating, depression, anxiety, and pain catastrophizing; and to use tobacco. CONCLUSION: Results support the presence of a restriction-of-range effect but do not demonstrate a floor effect. These data suggest that current outcome data for MBS patients may not generalize to those who report clinically significant psychopathology at the pre-MBS psychosocial evaluation and may warrant caution when using the current literature to inform clinical decision making for this group. Findings also suggest a need for interventions that will better engage Black patients.

Psychotropic Medications in Metabolic and Bariatric Surgery: Research Updates and Clinical Considerations.

PURPOSE OF REVIEW: We review evidence for assessing and monitoring psychotropic medications in metabolic and bariatric surgery (MBS) patients. We describe weight gain side effects, potential perioperative risks, pharmacokinetic changes that occur after MBS, and conclude with clinical recommendations. RECENT FINDINGS: Research on psychiatric medication use and post-MBS weight outcomes is lacking and inconsistent; however, there is consistent evidence that, though variable, psychiatric medication use is associated with weight gain. Several meta-analyses and reviews provide guidance on lowering risk when appropriate. Perioperative lithium toxicity and SSRI discontinuation syndrome also warrant consideration, as do potential post-operative pharmacokinetic changes. In the absence of data for each psychiatric drug classification, close symptom monitoring and, where appropriate, serum concentration monitoring are recommended. MBS patients are a psychiatrically vulnerable population, and many are on psychiatric medications. Given potential weight/metabolic side effects, perioperative complications, and post-operative pharmacokinetic changes that occur with psychotropic medication use, providers should stay well informed on psychiatric medication management considerations.

Sleep disturbance and insomnia in individuals seeking bariatric surgery.

BACKGROUND: Sleep disturbance is well established in individuals with obesity, and the relationship between poor sleep and obesity is supported by population, longitudinal, experimental, and intervention studies. However, the prevalence and characteristics of poor sleep in individuals seeking bariatric surgery have thus far been poorly examined. OBJECTIVES: We sought to characterize self-reported sleep parameters in individuals seeking bariatric surgery and to compare these data with controls. SETTING: Two Academic Medical Centers, United States, and an online survey of healthy controls. METHOD: Individuals seeking bariatric surgery (n = 427) completed presurgical psychological evaluations at 2 comprehensive bariatric surgery programs. Data on medical co-morbidities and from self-report questionnaires on sleep quality, insomnia, anxiety, and depression were abstracted from charts. Data from controls (n = 180) were collected using an online survey tool and compared with bariatric cases. RESULTS: Across study sites, 40.4% of bariatric cases took at least 30 minutes to fall asleep, 46.7% had insufficient total sleep time (<6.5 hr), 65.1% reported general poor sleep quality, and 30.8% reported clinically significant insomnia symptoms. Approximately 20% of the variance in poor sleep quality and insomnia was explained by body mass index, obstructive sleep apnea, anxiety, and depression. Cases and controls were similar, although bariatric cases reported significantly poorer sleep efficiency. CONCLUSIONS: Our results suggest that similar to a control population, the majority of patients seeking bariatric surgery are experiencing sleep difficulties. Presurgical assessment and treatment of sleep problems may be beneficial to patients and may help improve weight loss treatment outcomes. Optimally, assessment would include 1 of the 2 self-report questionnaires used herein, and treatment would involve Cognitive Behavioral Therapy for Insomnia. Future research assessing sleep patterns with objective measurement tools and evaluating the impact of sleep on postsurgical outcomes is warranted.

The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk.

BACKGROUND: Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations. AIM: The purpose of this study was to describe the rationale and design of the Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older. METHODS: This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼11-15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer. RESULTS: We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified ∼400 additional interested individuals. CONCLUSIONS: We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.

The Effects of a Remote-based Weight Loss Program on Adipocytokines, Metabolic Markers, and Telomere Length in Breast Cancer Survivors: the POWER-Remote Trial.

PURPOSE: We initiated a clinical trial to determine the proportion of breast cancer survivors achieving ≥5% weight loss using a remotely delivered weight loss intervention (POWER-remote) or a self-directed approach, and to determine the effects of the intervention on biomarkers of cancer risk including metabolism, inflammation, and telomere length. EXPERIMENTAL DESIGN: Women with stage 0-III breast cancer, who completed local therapy and chemotherapy, with a body mass index ≥25 kg/m2 were randomized to a 12-month intervention (POWER-remote) versus a self-directed approach. The primary objective was to determine the number of women who achieved at least 5% weight loss at 6 months. We assessed baseline and 6-month change in a panel of adipocytokines (adiponectin, leptin, resistin, HGF, NGF, PAI1, TNFα, MCP1, IL1ß, IL6, and IL8), metabolic factors (insulin, glucose, lipids, hs-CRP), and telomere length in peripheral blood mononuclear cells. RESULTS: From 2013 to 2015, 96 women were enrolled, and 87 were evaluable for the primary analysis; 45 to POWER-remote and 42 to self-directed. At 6 months, 51% of women randomized to POWER-remote lost ≥5% of their baseline body weight, compared with 12% in the self-directed arm [OR, 7.9; 95% confidence interval (CI), 2.6-23.9; P = 0.0003]; proportion were similar at 12 months (51% vs 17%, respectively, P = 0.003). Weight loss correlated with significant decreases in leptin, and favorable modulation of inflammatory cytokines and lipid profiles. There was no significant change in telomere length at 6 months. CONCLUSIONS: A remotely delivered weight loss intervention resulted in significant weight loss in breast cancer survivors, and favorable effects on several biomarkers.

A modified inpatient eating disorders treatment protocol for postbariatric surgery patients: patient characteristics and treatment response.

BACKGROUND: Bariatric surgery is currently the most effective treatment for obesity. However, outcomes vary and disordered eating may persist or emerge postsurgically. Severe postsurgical eating disorders may require inpatient treatment, and guidelines for the modification of inpatient nutritional treatment protocols for this population are lacking. OBJECTIVES: This paper describes a modified inpatient nutritional protocol for postsurgical patients with eating disorders treated on a behavioral eating disorders unit, and reports patient characteristics and treatment response. SETTINGS: This research was conducted at a university hospital. METHODS: Cases (n = 19) comprised 2% of all eating disorder admissions; 5 were underweight and required weight restoration. Clinical data collected via chart review included disordered eating behaviors, medical and psychiatric co-morbidity, and treatment course. RESULTS: All cases were status post Roux-en-Y gastric bypass (median 5 yr postsurgery). Onset of disordered eating preceded surgery in the majority, and intentional vomiting was the most commonly reported postsurgical disordered eating behavior. The sample was notable for a high level of psychiatric and medical co-morbidity. Patients responded well to the modified treatment protocols, with a majority of patients on the weight gain (60%) and weight maintenance (78%) post-bariatric surgery protocols discharged for clinical improvement. CONCLUSIONS: Postsurgical bariatric patients with eating disorders can be successfully treated on a specialized eating disorders unit. Modification of inpatient eating disorder protocols for those who have undergone bariatric surgery is necessary to address the different physiologic needs of this patient population while providing them with effective psychiatric care.

Decreased Escitalopram Concentrations Post-Roux-en-Y Gastric Bypass Surgery.

BACKGROUND: There is a high coincidence between obesity and psychiatric disorders including depression. Depressive disorders are commonly treated with antidepressants, including the selective serotonin reuptake inhibitor Lexapro (escitalopram). Although candidates for elective Roux-en-Y gastric bypass (RYGB) surgery may be treated with escitalopram, drug dosing strategies are typically not adjusted postoperatively. Therefore, studies are needed to better characterize escitalopram drug concentrations in a postsurgical setting. METHODS: Turbulent flow-liquid chromatographic-tandem mass spectrometric methods were used to quantify escitalopram concentrations in serum in study participants approved for RYGB. Blood was collected from study subjects 2 weeks before surgery, and 2 and 6 weeks postoperatively, to assess the impact of RYGB on systemic drug concentrations. RESULTS: Twelve samples from 4 study participants were collected and analyzed for serum escitalopram concentrations. Two weeks post-RYGB, although there were minimal changes in each participant's body mass index (<5%), drug concentrations were 33% (4%-71%) decreased as compared with presurgical serum concentrations. There were further decreases in drug concentrations 6 weeks postsurgery. All clinical laboratory values were within normal reference intervals. CONCLUSIONS: RYGB significantly alters the gastrointestinal tract and impacts escitalopram drug concentrations, even shortly after surgery.

Refeeding and weight restoration outcomes in anorexia nervosa: Challenging current guidelines.

OBJECTIVE: Cohort study from February 2003 through May 2011 to determine weight restoration and refeeding complication outcomes for patients with anorexia nervosa (AN) treated in an integrated inpatient-partial hospital eating disorder program designed to produce rapid weight gain and weight restoration in the majority. METHOD: Consecutive admissions (females and males, adolescents and adults; N = 361 patients, 461 admissions) at least 1.8 kg below target weight with AN or subthreshold variants were included. Main outcome measures were rates of hypophosphatemia, transfer to medicine, or death; rates of weight gain and percent achieving weight restoration. RESULTS: Hypophosphatemia was present in 7.9% of cases at admission and in 18.5% at some point during treatment. Hypophosphatemia was mild to moderate. Lower admission body mass index (BMI), but not rate of weight gain, predicted hypophosphatemia [OR = 0.65; p < .00001 (95% CI 0.57-0.76)]. Five patients (1.1%) were transferred to medicine or surgery, none because of refeeding. There were no deaths. Mean inpatient weight gain was 1.98 kg/week; mean partial hospital weight gain was 1.36 kg/week. By program discharge, 71.8% of adults reached a BMI of 19, 58.5% a BMI of 20. For adolescents, 80.4% came within 2 kg of their target weight; 76.1% came within 1 kg. DISCUSSION: Refeeding patients with AN using a hospital-based, behavioral protocol may be accomplished safely and more rapidly than generally recognized, weight restoring most patients by discharge. Helpful elements may include the program's integrated, step-down structure; multidisciplinary team approach emphasizing group therapy to effect behavior change; and close medical monitoring for those with BMI < 15.

Application of Latent Class Analysis to Identify Behavioral Patterns of Response to Behavioral Lifestyle Interventions in Overweight and Obese Adults.

BACKGROUND: Examining responders and non-responders to behavioral lifestyle interventions among overweight/obese adults with additional comorbidities may aid in refining and tailoring obesity treatment. PURPOSE: The purpose of this study is to demonstrate the use of latent class analysis to identify patterns of response to behavioral lifestyle interventions based on adherence to diet and exercise recommendations. METHOD: Repeated measures latent class analysis was applied to two clinical trial datasets, combination of two active interventions in the PREMIER Trial (n = 501) and phase 1 of the Weight Loss Maintenance Trial (WLM; n = 1685), to identify patterns of response to behavioral lifestyle interventions. Treatment response was based on adherence to daily recommendations for fruit/vegetable, fat, saturated fat, sodium, and exercise at baseline and 6 months. RESULTS: In PREMIER, three distinct latent classes emerged: responders (45.9%), non-responders (23.6%), and early adherers (30.5%). Responders and Early Adherers had greater weight loss at 6 and 18 months and were more likely to meet behavioral recommendations at 18 months than Non-responders. For WLM, there were four latent classes: partial responders (16%), non-responders (40%), early adherers (2%), and fruit/veggie only responders (41%). Non-responders in WLM had significantly less weight loss at 6 months compared to that of the other three latent classes. CONCLUSION: Latent class analysis is a useful method to apply to clinical trial data to identify distinct patterns of response to behavioral interventions. Overweight/ obese participants who respond to behavioral lifestyle treatment (i.e., meet behavioral recommendations) have significantly greater weight loss than that of participants who do not make behavioral changes.

Examining behavioral processes through which lifestyle interventions promote weight loss: results from PREMIER.

OBJECTIVE: To examine the behavioral processes through which lifestyle interventions impacted weight loss. METHODS: The analyses were limited to overweight and obese Black and White adults randomized to a PREMIER lifestyle intervention (N = 501). Structural equation modeling was conducted to test the direct and indirect relationships of session attendance, days of self-monitoring diet and exercise, change in diet composition and exercise, and 6-month weight change. RESULTS: Greater session attendance was associated with increased self-monitoring, which was in turn significantly related to reduction in percent energy from total fat consumed. Change in percent energy from fat and self-monitoring was associated with 6-month percent change in weight. Both a decrease in fat intake and increase in self-monitoring are potential mediators of the relationship between attendance and weight change. CONCLUSIONS: The findings provide a reasonable model that suggests regular session attendance and use of behavioral strategies like self-monitoring are associated with improved behavioral outcomes that are associated with weight loss.

A screening tool to assess and manage behavioral risk in the postoperative bariatric surgery patient: The WATCH.

Bariatric surgery is increasingly recognized as a highly effective treatment for individuals who are severely obese. Amount of weight loss and resolution of comorbidities surpass those of nonsurgical approaches; however, suboptimal weight loss and weight regain are not uncommon. These outcomes, though not fully understood, are likely at least partially explained by failure to make long-term behavioral and/or cognitive changes. We are unaware of any established clinical tools to guide providers in assessing postoperative behaviors and identifying those who may require specialized treatment. The goal of this paper is to introduce a brief screening tool, The WATCH, to help clinicians assess and identify patients who may be at risk for poor or untoward outcomes post bariatric surgery. We first review the literature on postoperative outcomes, including weight loss, resolution of comorbidities, suboptimal outcomes, and development of problematic eating behaviors. We then provide an easily-recalled, five-item tool that assesses outcomes, and discuss patient responses that may necessitate further intervention or referral.

Cosmetic surgery in inpatients with eating disorders: attitudes and experience.

Body image disturbance is frequent among individuals undergoing cosmetic surgery and core to the pathology of eating disorders (ED); however, there is little research examining cosmetic surgery in ED. This study examined body image related measures, ED behaviors, and depression as predictors of attitudes toward cosmetic surgery in 129 women with ED. Patients who had undergone surgery (n=16, 12%) were compared to those who had not. Having a purging diagnosis, linking success to appearance, and making physical appearance comparisons were predictive of more favorable cosmetic surgery attitudes. All of those who had undergone surgery had purging diagnoses and, on average, were older, had higher BMIs, and were more likely to make physical appearance comparisons and know someone who had undergone surgery. In ED, acceptance and pursuit of cosmetic surgery appears to be related to social group influences more than weight and shape disturbance, media influences, or mood.

Oral sensory and cephalic hormonal responses to fat and non-fat liquids in bulimia nervosa.

Sensory evaluation of food involves endogenous opioid mechanisms. Bulimics typically limit their food choices to low-fat "safe foods" and intermittently lose control and binge on high-fat "risk foods". The aim of this study was to determine whether the oral sensory effects of a fat versus a non-fat milk product (i.e., traditional versus non-fat half-and-half) resulted in different subjective and hormonal responses in bulimic women (n=10) compared with healthy women (n=11). Naltrexone (50mg PO) or placebo was administered 1h before, and blood sampling began 30 min prior to and 29 min after, a 3 min portion controlled modified sham-feeding trial. Following an overnight fast, three morning trials (fat, naltrexone; fat, placebo; and non-fat, placebo) were administered in a random double-blind fashion separated by at least 3 days. Overall, there were no differences between Fat and Non-Fat trials. Hunger ratings (p<0.001) and pancreatic polypeptide levels (p<0.05) were higher for bulimics at baseline. Bulimics also had overall higher ratings for nausea (p<0.05), fatty taste (p<0.01), and fear of swallowing (p<0.005). Bulimics had approximately 40% higher total ghrelin levels at all time points (p<0.001). Hormones and glucose levels were not altered by the modified sham-feeding paradigm. Naltrexone, however, resulted in an overall increase in blood glucose and decrease in ghrelin levels in both groups (p<0.05, for both). These data suggest that bulimic women have different orosensory responses that are not influenced by opioid receptor antagonism, evident in hormonal responses, or dependent on the fat content of a similarly textured liquid.

Repeated binge access to a palatable food alters feeding behavior, hormone profile, and hindbrain c-Fos responses to a test meal in adult male rats.

Repetitive cycles of palatable food access and chronic calorie restriction alter feeding behaviors and forebrain neural systems. The purpose of this study was to determine the behavioral, endocrine, and meal-related hindbrain neural activation in adult male Sprague-Dawley rats exposed to a binge-access feeding schedule. The binge-access schedule consisted of repeated twice-per-week episodes of acute calorie restriction (to one-third of the previous day's intake) followed by 2 h of concurrent access to high-calorie palatable food (sweetened fat: 90% vegetable shortening-10% sucrose) and chow. The binge-access rats consumed more calories during the "binge" period than rats with continuous access to sweetened fat (continuous-access group) or subjected to repeated acute calorie restriction only (chow-restricted group). The binge-access group also exhibited a approximately 25% increase in sweetened fat intake from week 1 to week 6. Persistence of the binge phenotype in the binge-access animals was demonstrated 2 wk, but not 4 wk, after ad libitum chow. The binge-access and chow-restricted groups maintained a similar normal body composition and hormonal profiles, whereas the continuous-access animals developed an obese phenotype. Terminal ghrelin levels were significantly higher in the binge-access group than in the continuous-access group. Consumption of a standardized meal resulted in more c-Fos-positive cells along the anterior-posterior nucleus of the solitary tract regions in the binge-access group than in naive controls. These results suggest that repeated cycles of acute calorie restriction followed by palatable food produce physiological alterations that may facilitate overconsumption of a highly palatable food during limited-access periods.

Insulin, glucose, and pancreatic polypeptide responses to a test meal in restricting type anorexia nervosa before and after weight restoration.

Prolonged malnutrition in individuals with anorexia nervosa (AN) has been associated with alterations in endocrine function that may play a sustaining role in the disorder. We hypothesized that abnormalities in endocrine responses to ingestion of a meal in AN are reversible and depend on weight restoration. We measured meal-induced endocrine responses in AN subjects at three time points during hospitalization: before refeeding (n = 13, mean BMI 16.7 kg/m(2)), after 2 wk of refeeding (mean BMI 18.0 kg/m(2)), and in the weight-restored state (mean BMI 20.3 kg/m(2)). Control subjects (n = 13, BMI 19-24.9 kg/m(2)) were tested once. Tests were 2.5-h sessions in which blood was drawn every 15 min before, during, and after a approximately 650-kcal test breakfast. Relative to controls, peak levels of glucose were depressed and peak levels of insulin in response to ingestion of the test meal were delayed, with response patterns in the third trial most similar to controls. Pancreatic polypeptide (PP) levels were increased in AN relative to controls regardless of weight status. The delay in insulin release and elevated PP levels did not correct with short-term refeeding and may contribute to the high relapse rates and maintenance of AN.