Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol.

INTRODUCTION: Obesity is one of the main threats to public health in western countries and increases the risk of several diseases, overall morbidity and mortality. Sustained weight loss will reduce risk factors and improve several obesity comorbidities. Options are conservative treatment such as lifestyle changes, bariatric surgery or medications. Conservative treatment has a low success rate, and bariatric surgery is typically not reversible, with the risk of complications and recurrences. Treatment of obesity with medications has in recent years shown great promise, but the side effects are many, and the long-term effect is unknown. There is also a need for an option for patients where surgery has contraindications and conservative follow-up does not succeed.The research on obesity and gut microbiota has yielded promising results regarding weight reduction and metabolic health, but more research is needed to better understand the relationship between gut microbiota and severe obesity. This study could show proof of concept that gut microbiota from a lean donor could, in addition to lifestyle intervention, contribute to weight reduction in people suffering from severe obesity. METHOD AND ANALYSIS: This study aims to investigate if a fecal microbiota transplantation (FMT) from a lean donor leads to weight reduction in participants suffering from severe obesity. The study is a single-centre, double-blinded, placebo-controlled, parallel-group study with 60 participants. Participants will be randomised 1:1 for FMT from a lean donor or placebo. FMT or placebo will be delivered once by enema.We will include participants from the outpatient clinic for severe obesity, at the Medical Department, University Hospital of North Norway, Harstad, by invitation only. The study has a follow-up period of 12 months, with study visits of 3, 6 and 12 months post FMT. The primary endpoint is a weight reduction of ≥10%, 12 months after intervention.The results of the study will be published in open access journals. At the end of the study, the participants will receive information on which treatment group they belong to. ETHICS AND DISSEMINATION: The Regional Ethical Committee in North Norway (REK) approved the study protocol (2017/1655/REK Nord). We plan to present the results from the study at (inter)national conferences and publish in open-access general peer-reviewed journals. The enema method for FMT administration used in this study was developed by our study team. TRIAL REGISTRATION NUMBER: NCT03273855.

Nutritional and food education as a complementary treatment approach in severe obese individuals.

Background: The treatment for obesity, specifically severe obesity, is a challenge for health professionals and services. It requires a multidisciplinary and holistic approach covering the complexity and difficulties of incorporating healthy habits to prevent associated diseases and mortality. Individual intervention's methods are not enough to change eating habits. Objective: To describe and investigate the contribution of nutritional and food education as a complementary therapeutic approach in the treatment of individuals with severe obesity and their family members. Methods: A multidisciplinary team adopted a group approach. A different topic was addressed at each therapeutic meeting to assist in the nutritional treatment of obesity, such as diet and healthy habits i.e. barriers to lifestyle changes. The topics were developed based on different methodological and teaching approaches to facilitate adherence to non-drug treatment. Results: Overall, there was a greater understanding towards the adoption of healthy eating habits of the whole family, greater motivation to adhere to dietary changes and adoption of a more physical active lifestyle. This interventional educational support methodology had been accepted in such a positive way for patients and their relatives. Family member participation expands the possibilities of establishing necessary and lasting changes in the lifestyle of not only the patients, but their whole families. Conclusion: Health education actions constitute an important complementary therapeutic approach in promoting health and preventing complications in individuals with severe obesity. This article can be useful to enlarge the debate on the subject and face the challenges related to the effective treatment of obesity, notably severe obesity.

Deep Brain Stimulation for Morbid Obesity: An Underutilized Neuromodulatory Treatment for Severely Obese Patients?

BACKGROUND: Morbid obesity (MO) has been steadily increasing in the last few years. Pharmacotherapy and bariatric surgeries remain the main treatment modalities for MO, although in the long-term they may lose their effectiveness. Other treatment approaches are urgently needed and deep brain stimulation (DBS) is a promising therapy. Disturbed energy homeostasis caused by intake of highly palatable and caloric foods may induce hedonic eating. The brain nuclei responsible for energy homeostasis and hedonia are the hypothalamic nuclei and nucleus accumbens. These brain structures constitute the stereotactic targets approached with DBS to treat MO. MATERIAL AND METHODS: We have performed a literature search of all available clinical applications of DBS for MO in humans. We were able to identify three case series reports and additional six case reports involving 16 patients. The selected stereotactic targets included lateral hypothalamus in eight patients, ventromedial hypothalamus in two patients, and nucleus accumbens in six patients. RESULTS: In general, the safety profile of DBS in refractory MO patients was good. Clinical improvement regarding the mean body mass index could be observed in obese patients. CONCLUSIONS: MO is a demanding condition. Since in some cases standardized treatment is ineffective, new therapies should be implemented. DBS is a promising therapy that might be used in patients suffering from MO, however, more studies incorporating more individuals and with a longer follow-up are needed to obtain more reliable results concerning its effectiveness and safety profile.

Fecal microbial transplantation and fiber supplementation in patients with severe obesity and metabolic syndrome: a randomized double-blind, placebo-controlled phase 2 trial.

Fecal microbial transplantation (FMT) from lean donors to patients with obesity has been associated with metabolic benefits, yet results so far have been inconsistent. In this study, we tested the application of daily fiber supplementation as an adjunct to FMT therapy to modulate cardiometabolic outcomes. We performed a double-blind randomized trial in patients with severe obesity and metabolic syndrome receiving oral FMT, to test high-fermentable (HF) and low-fermentable (LF) fiber supplements (NCT03477916). Seventy participants were randomized to the FMT-HF (n = 17), FMT-LF (n = 17), HF (n = 17) and LF (n = 19) groups. The primary outcome was the assessment of change in insulin sensitivity from baseline to 6 weeks using the homeostatic model assessment (HOMA2-IR/IS). After 6 weeks, only patients in the FMT-LF group had significant improvements in HOMA2-IR (3.16 ± 3.01 at 6 weeks versus 3.77 ± 3.57 at baseline; P = 0.02). No difference in HOMA2-IR was observed over this period for those in the FMT-HF group (3.25 ± 1.70 at 6 weeks versus 3.17 ± 1.72 at baseline; P = 0.8), the HF group (3.49 ± 1.43 at 6 weeks versus 3.26 ± 1.33 at baseline; P = 0.8) or the LF group (3.76 ± 2.01 at 6 weeks versus 3.56 ± 1.81 at baseline; P = 0.8). Interventions were safe and well-tolerated with no treatment-attributed serious adverse events. We provide proof of concept for the use of a single-dose oral FMT combined with daily low-fermentable fiber supplementation to improve insulin sensitivity in patients with severe obesity and metabolic syndrome.

Developing Integrated Clinical Pathways for the Management of Clinically Severe Adult Obesity: a Critique of NHS England Policy.

PURPOSE OF THE REVIEW: Pathways for obesity prevention and treatment are well documented, yet the prevalence of obesity is rising, and access to treatment (including bariatric surgery) is limited. This review seeks to assess the current integrated clinical pathway for obesity management in England and determine the major challenges. RECENT FINDINGS: Evidence for tier 2 (community-based lifestyle intervention) and tier 3 (specialist weight management services) is limited, and how it facilitates care and improve outcomes in tier 4 remains uncertain. Treatment access, rigidity in pathways, uncertain treatment outcomes and weight stigma seems to be major barriers to improved care. More emphasis must be placed on access to effective treatments, treatment flexibility, addressing stigma and ensuring treatment efficacy including long-term health outcomes. Prevention and treatment should both receive significant focus though should be considered to be largely separate pathways. A simplified system for weight management is needed to allow flexibility and the delivery of personalized care including post-bariatric surgery care for those who need it.

Recommendations Based on Evidence by the Andalusian Group for Nutrition Reflection and Investigation (GARIN) for the Pre- and Postoperative Management of Patients Undergoing Obesity Surgery.

In order to develop evidence-based recommendations and expert consensus for nutrition management of patients undergoing bariatric surgery and postoperative follow-up, we conducted a systematic literature search using PRISMA methodology plus critical appraisal following the SIGN and AGREE-II procedures. The results were discussed among all members of the GARIN group, and all members answered a Likert scale questionnaire to assess the degree of support for every recommendation. Patients undergoing bariatric surgery should be screened preoperatively for some micronutrient deficiencies and treated accordingly. A VLCD (Very Low-Calorie Diet) should be used for 4-8 weeks prior to surgery. Postoperatively, a liquid diet should be maintained for a month, followed by a semi-solid diet also for one month. Protein requirements (1-1.5 g/kg) should be estimated using adjusted weight. Systematic use of specific multivitamin supplements is encouraged. Calcium citrate and vitamin D supplements should be used at higher doses than are currently recommended. The use of proton-pump inhibitors should be individualised, and vitamin B12 and iron should be supplemented in case of deficit. All patients, especially pregnant women, teenagers, and elderly patients require a multidisciplinary approach and specialised follow-up. These recommendations and suggestions regarding nutrition management when undergoing bariatric surgery and postoperative follow-up have direct clinical applicability.

Effects of Inspiratory Exercise With Linear and Nonlinear Load on Respiratory Variables Post-Bariatric Surgery.

BACKGROUND: Obesity leads to changes in respiratory function, causing reduced lung volumes and mechanical disadvantage of the respiratory muscles. We sought to evaluate the effect of breathing exercises using devices that impose linear and nonlinear load on reversing diaphragm dysfunction and the prevalence of atelectasis after bariatric surgery. METHODS: This was a blind randomized clinical trial. Preoperatively, we assessed the subjects' maximum inspiratory pressure by measuring nasal inspiratory pressure and respiratory muscle endurance with an incremental test based on sustained maximum inspiratory pressure (sustained PImax) and the prevalence of atelectasis by chest radiograph. Subjects were then randomized into 2 groups: a linear load pressure group and nonlinear load pressure group; both groups received conventional respiratory physiotherapy. Subjects were reassessed on the second day after bariatric surgery. RESULTS: We included 40 morbidly obese women (body mass index > 40 kg/m2), age 25-55 years, who underwent bariatric surgery by laparotomy. The groups were homogeneous with respect to age (P = .11), body mass (P = .12), height (P = .75), body mass index (P = .75), nasal inspiratory pressure (P = .48), sustained PImax (P = .89), and absence of atelectasis at baseline. In the reassessment, both groups showed significant reduction in nasal inspiratory pressure (P < .001) and maintenance of sustained PImax (linear load pressure P = .51; nonlinear load pressure P = .055). The prevalence of atelectasis was 15% for linear load pressure and 25% for nonlinear load pressure, with no significant difference between groups (P = .69). CONCLUSION: Both groups were able to maintain respiratory muscle endurance after bariatric surgery. In addition, the treatment contributed to controlling atelectasis so that it did not cause clinical repercussions to the subjects. (ClinicalTrials.gov registration NCT02298517).

Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial.

BACKGROUND: The AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity. OBJECTIVES: We earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes. SETTING: United States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization). METHODS: AT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis. RESULTS: Of the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders. CONCLUSIONS: The results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior.

[Psychosocial Characteristic and Health Care for Unemployed Youths with Extreme Obesity - A Model Project]. / Psychosoziale Charakterisierung und Integrative Versorgung arbeitsloser Jugendlicher mit extremer Adipositas ­ ein Modellprojekt.

INTRODUCTION: In clinical care, unemployed youths have limited access to available obesity treatments including obesity surgery. With the implementation of a specialized obesity outpatient unit in cooperation with five German job-centers we aim to prove whether unemployed youths are interested in obesity treatment and how they adhere to a multilevel obesity treatment in terms of participation rates. MATERIALS AND METHODS: Youths (aged 15.0-24.9 years) with a body-mass-index (BMI) ≥30 kg/m2 were initially offered an individualized patient information concerning obesity treatment on the premises of the job-center. If interested, youths were included in the multicomponent treatment program (6 sessions). Those who participated in a minimum of 5 out of 6 treatment sessions were offered access to a preparation course (4 sessions) and an individualized evaluation of the indication for obesity surgery. RESULTS: Between 2012 and 2017, 83 youths (mean age 21.1 years, BMI 48.1 kg/m2, BMI 35.0-39.9 kg/m2: N=7, ≥40 kg/m2: N=71) were enrolled in the treatment program. 34 participated in ≥5/6 sessions in the multicomponent obesity treatment and 20 expressed an interest in obesity surgery. To date, 11 adolescents underwent obesity surgery with a mean BMI reduction of 14.3 kg/m2 between 3 and 36 months after obesity surgery (excess weight loss 27.3%) vs. 3.8 kg/m2 between 6 and 48 months after treatment initiation in the group of youths who did not receive obesity surgery. 13 youths were integrated in the primary labor market. DISCUSSION: Several unemployed youths accepted our treatment program and improved their health and vocational status in the course of their participation. CONCLUSIONS: The implementation of a specialized obesity outpatient unit within German job-centers is a successful strategy to characterize this high-risk-group and to determine their individual treatment needs. This finding must be confirmed with a larger sample size and by evaluating the long-term course of treatment.

Case Reports: Multifaceted Experiences Treating Youth with Severe Obesity.

The management of youth with severe obesity is strongly impacted by social determinants of health and family dynamics. We present case studies of three patients seen in our tertiary care obesity treatment clinic as examples of the challenges faced by these patients and their families, as well as by the medical team. We discuss how these cases illustrate potential barriers to care, the role of child protective services, and we reflect upon lessons learned through the care of these patients. These cases highlight the need for comprehensive care in the management of youth with severe obesity, which can include: visits to multiple medical specialists, and mental and behavioral health providers; school accommodations; linkage to community resources; and, potentially, child protective services involvement. Through the care of these youth, our medical team gained more experience with using anti-obesity medications and meal replacements. The care of these youth also heightened our appreciation for the integral role of mental health services and community-based resources in the management of youth with severe obesity.

Fractures in Adults After Weight Loss from Bariatric Surgery and Weight Management Programs for Obesity: Systematic Review and Meta-analysis.

BACKGROUND: Weight loss interventions for obesity, such as bariatric surgery, are associated with reductions in bone mineral density and may increase the risk of fractures. We undertook a systematic review and meta-analysis of bariatric surgery and lifestyle weight management programs (WMPs) with fracture outcomes. METHODS: We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials from 1966 to 2018, and our trial registry of WMP randomized controlled trials (RCTs). We included RCTs, non-randomized trials, and observational studies of bariatric surgery, and RCTs of WMPs. Studies had follow-up ≥ 12 months, mean group body mass index ≥ 30 kg/m2. The primary outcome measure was incidence of any type of fracture in participants, and the secondary outcome was weight change. We used random effects meta-analysis for trial data. RESULTS: Fifteen studies were included. Three small trials provided short-term evidence of the association between bariatric surgery and participants with any fracture (365 participants; RR 0.82; 95% CI 0.29 to 2.35). Four out of six observational studies of bariatric surgery demonstrated significantly increased fracture risk. Six RCTs of WMPs with 6214 participants, the longest follow-up 11.3 years, showed no clear effect on any type of fracture (RR 1.04; 95% CI 0.91 to 1.18), although authors of the largest RCT reported an increased risk of frailty fracture by their definition (RR 1.40; 95% CI 1.04 to 1.90). CONCLUSION: Bariatric surgery appears to increase the risk of any fracture; however, longer-term trial data are needed. The effect of lifestyle WMPs on the risk of any fracture is currently unclear.

Willing to go the extra mile: Prospective evaluation of an intensified non-surgical treatment for patients with morbid obesity.

BACKGROUND & AIMS: Bariatric surgery has been well established and considered the treatment of choice in morbid obesity. However, some patients refuse surgery because long-term effects have not been fully elucidated, quality of life might change and lifelong supplementation with vitamins and trace elements may be required. Our aim was to exhaust non-surgical treatment modalities and to evaluate such an intensified treatment alternative. METHODS: A total of 206 patients (mean age = 46 years; BMI = 49 kg/m2) enrolled since 2013 into a non-surgical multimodality obesity treatment program covered by major health insurances were prospectively evaluated over a three year period. The 12-month treatment course comprised 57 h cognitive-behavioral therapy, 53.5 h physical exercise training, and 43.5 h nutritional therapy offered in small groups. Weight loss was induced by a formula-based, very low-calorie diet for 12 weeks in combination with a gastric balloon. The primary outcome was relative weight loss (RWL). Secondary outcome measures were waist-to-hip ratio, blood pressure, antihypertensive drug treatment, anti-diabetic medication, HbA1c, and quality of life. RESULTS: 166 Patients (81%) completed treatment. Mean (±SD) weight loss after 12 months for women and men were 28.8 kg (±14.7) and 33.7 kg (±19.5), respectively, among completers. RWL was 21.9% (±10.0) and excess weight loss (EWL) was 46.9% (±22.2), whereas intention-to-treat analysis revealed a RWL of 20.0% (±10.4) and an EWL of 42.9% (±22.9). Weight loss was accompanied by improved quality of life, lowered HbA1c values, and a significantly reduced need of antihypertensive and diabetes medications over the study period. Three year follow-up data from the first 78 patients (76% follow-up rate) revealed a RWL of 13% (±13.1) and an EWL of 27.2% (±28.8). The majority of patients (51%) maintained a RWL of 10% or more, and 44% had an EWL > 30%. CONCLUSIONS: In patients with morbid obesity, an intensified non-surgical multimodality treatment program may achieve significant and sustained weight loss accompanied by improvement of disease markers as well as quality of life for at least three years.

Resistance training during a 12-week protein supplemented VLCD treatment enhances weight-loss outcomes in obese patients.

BACKGROUND: This investigation evaluated the efficacy by which resistance training enhances body composition, metabolic, and functional outcomes for obese patients undergoing a 12-week medically supervised hypocaloric treatment. METHODS: This was a single-blind, randomized, parallel-group prospective trial. Morbidly obese patients were prescribed a 12-week proprietary very low calorie diet (VLCD) treatment (Optifast®) with supplemental protein (1120 kcals/day) and were placed in one of two groups for 14 weeks: 1) Standard Treatment Control (CON) (n = 5) or 2) Resistance Training (RT) (n = 6). Both groups underwent a pedometer-based walking program; however only RT performed resistance training 3 days/week for 12 weeks. Body composition, resting energy expenditure (REE), neuromuscular function, and serum biomarkers were measured at weeks 0, 6, and 13. RESULTS: Both groups exhibited a significant loss of total body mass (TBM) (CON: -19.4 ± 2.3 kg, p = 0.0009 vs. RT: -15.8 ± 1.5 kg, p = 0.0002) and fat mass (FM) (CON: -14.7 ± 1.8 kg, p = 0.0002 vs. RT: -15.1 ± 2.1 kg, p = 0.0002) with no group differences. CON lost 4.6 ± 0.8 kg (p = 0.004) of lean mass (LM) while RT demonstrated no changes. Group differences were found for the relative proportion of total weight-loss due to FM-loss (CON: 75.6 ± 3.4% vs. RT: 96.0 ± 6.0%, p = 0.03) and LM-loss (CON: 24.4 ± 3.2% vs. RT: 4.0 ± 6.5%, p = 0.03). CON demonstrated a 328.6 ± 72.7 kcal/day (-14.3 ± 2.4%) (p = 0.02) decrease in REE while RT exhibited a non-significant decrease of 4.6 ± 1.6% (p = 0.78). RT demonstrated greater improvements in all measures of contractile function and strength when compared to CON (p < 0.05). At post-treatment, RT exhibited greater serum free fatty acids (p = 0.01), glycerol (p = 0.003), and ß-hydroxybutyrate (p = 0.005) than CON. CONCLUSION: Resistance training was advantageous for weight-loss composition by preservation of LM without compromising overall weight- or fat-loss in morbidly obese men and women undergoing a protein supplemented VLCD. These changes accompanied positive adaptations for resting metabolism and muscular function.

Improved Magnesium Levels in Morbidly Obese Diabetic and Non-diabetic Patients After Modest Weight Loss.

Serum magnesium (Mg) is reported to be reduced in individuals with obesity, hypertension, and diabetes mellitus and has been suggested as a marker for metabolic syndrome. We have studied changes in serum Mg concentrations in a group of obese patients (n = 92) with and without diabetes mellitus after weight loss induced by dieting and bariatric surgery. At inclusion, 11% (10/92) of the population had severe Mg deficiency (< 0.75 mmol/L) and median serum Mg was lower in diabetic (n = 20) compared to non-diabetic (n = 72) patients (p = 0.002). A weight loss of 10 kg after 8 weeks of lifestyle interventions was accompanied by increased serum Mg of about 5% in both diabetic and non-diabetic patients. Serum Mg remained stable thereafter in the non-diabetic patients, while it continued to increase in the diabetic patients after bariatric surgery. Six months after bariatric surgery, there was no significant difference in serum Mg concentration between the groups (p = 0.08). The optimal range of circulating Mg concentration is not known, but as even small increments in serum Mg are reported to lower the risk of cardiovascular and ischemic heart disease, our results are interesting in a public health perspective.

Effects of Self-Conditioning Techniques (Self-Hypnosis) in Promoting Weight Loss in Patients with Severe Obesity: A Randomized Controlled Trial.

OBJECTIVE: The usefulness of the rapid-induction techniques of hypnosis as an adjunctive weight-loss treatment has not been defined. This randomized controlled trial evaluated whether self-conditioning techniques (self-hypnosis) added to lifestyle interventions contributed to weight loss (primary outcome), changes in metabolic and inflammatory variables, and quality of life (QoL) improvement (secondary outcomes) in severe obesity. METHODS: Individuals (with BMI = 35-50 kg/m2 ) without organic or psychiatric comorbidity were randomly assigned to the intervention (n = 60) or control arm (n = 60). All received exercise and behavioral recommendations and individualized diets. The intervention consisted of three hypnosis sessions, during which self-hypnosis was taught to increase self-control before eating. Diet, exercise, satiety, QoL, anthropometric measurements, and blood variables were collected and measured at enrollment and at 1 year (trial end). RESULTS: A similar weight loss was observed in the intervention (-6.5 kg) and control (-5.6 kg) arms (ß = -0.45; 95% CI: -3.78 to 2.88; P = 0.79). However, habitual hypnosis users lost more weight (-9.6 kg; ß = -10.2; 95% CI: -14.2 to -6.18; P < 0.001) and greatly reduced their caloric intake (-682.5 kcal; ß = -643.6; 95% CI: -1064.0 to -223.2; P = 0.005) in linear regression models. At trial end, the intervention arm showed lower C-reactive protein values (ß = -2.55; 95% CI: -3.80 to -1.31; P < 0.001), higher satiety (ß = 19.2; 95% CI: 7.71-30.6; P = 0.001), and better QoL (ß = 0.09; 95% CI: 0.02-0.16; P = 0.01). CONCLUSIONS: Self-hypnosis was not associated with differences in weight change but was associated with improved satiety, QoL, and inflammation. Indeed, habitual hypnosis users showed a greater weight loss.

Therapeutic potential of deep brain stimulation of the nucleus accumbens in morbid obesity.

OBJECTIVE Morbid obesity is a growing problem worldwide. The current treatment options have limitations regarding effectiveness and complication rates. New treatment modalities are therefore warranted. One of the options is deep brain stimulation (DBS) of the nucleus accumbens (NAC). This review aims to summarize the current knowledge on NAC-DBS for the treatment of morbid obesity. METHODS Studies were obtained from multiple electronic bibliographic databases, supplemented with searches of reference lists. All animal and human studies reporting on the effects of NAC-DBS on body weight in morbidly obese patients were included. Articles found during the search were screened by 2 reviewers, and when deemed applicable, the relevant data were extracted. RESULTS Five relevant animal experimental papers were identified, pointing toward a beneficial effect of high-frequency stimulation of the lateral shell of the NAC. Three human case reports show a beneficial effect of NAC-DBS on body weight in morbidly obese patients. CONCLUSIONS The available literature supports NAC-DBS to treat morbid obesity. The number of well-conducted animal studies, however, is very limited. Also, the optimal anatomical position of the DBS electrode within the NAC, as well as the optimal stimulation parameters, has not yet been established. These matters need to be addressed before this strategy can be considered for human clinical trials.

Nutritional issues in patients with obesity and cirrhosis.

Obesity and metabolic syndrome are considered as responsible for a condition known as the non-alcoholic fatty liver disease that goes from simple accumulation of triglycerides to hepatic inflammation and may progress to cirrhosis. Patients with obesity also have an increased risk of primary liver malignancies and increased body mass index is a predictor of decompensation of liver cirrhosis. Sarcopenic obesity confers a risk of physical impairment and disability that is significantly higher than the risk induced by each of the two conditions alone as it has been shown to be an independent risk factor for chronic liver disease in patients with obesity and a prognostic negative marker for the evolution of liver cirrhosis and the results of liver transplantation. Cirrhotic patients with obesity are at high risk for depletion of various fat-soluble, water-soluble vitamins and trace elements and should be supplemented appropriately. Diet, physical activity and protein intake should be carefully monitored in these fragile patients according to recent recommendations. Bariatric surgery is sporadically used in patients with morbid obesity and cirrhosis also in the setting of liver transplantation. The risk of sarcopenia, micronutrient status, and the recommended supplementation in patients with obesity and cirrhosis are discussed in this review. Furthermore, the indications and contraindications of bariatric surgery-induced weight loss in the cirrhotic patient with obesity are discussed.

Two-Year Nutrition Data in Terms of Vitamin D, Vitamin B12, and Albumin After Bariatric Surgery and Long-term Fracture Data Compared with Conservatively Treated Obese Patients: a Retrospective Cohort Study.

INTRODUCTION: Nutritional deficiencies may occur after bariatric surgery despite supplementation. Fracture risk may also be elevated after bariatric surgery. OBJECTIVES: To compare 25-hydroxyvitamin D [25(OH)D], vitamin B12, and albumin serum concentrations in severely obese patients who had undergone either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Fracture data was compared with data for a conservatively treated group of severely obese patients. METHODS: We considered 253 RYGB and 142 SG performed between 2007 and 2010. At 1- and 2-year control follow-ups, weight was measured and blood samples were drawn. The control group of 199 obese patients received lifestyle intervention and weight was measured at 1 and 2 years post-intervention between 2002 and 2006. We retrospectively collected fracture data for all patients through the end of 2016. RESULTS: At follow-ups, the mean serum 25(OH)D and albumin levels were within reference ranges and were similar between the RYGB and SG groups. Serum median vitamin B12 level was significantly higher in the SG group compared with the RYBG group, 319 versus 286 pmol/L at 2 years, respectively, p = 0.04. The cumulative risk for fracture was higher in the bariatric groups compared with the control group. The Cox multivariate model showed higher age, bariatric surgery, and lower body mass index (BMI) at the 2-year control increased the risk for fracture after obesity treatment. CONCLUSION: Vitamin 25(OH)D, B12, and albumin levels were mainly within recommended levels during the 2 years after bariatric surgery. The cumulative fracture risk was higher in bariatric patients.

Effects of multidisciplinary interventions on weight loss and health outcomes in children and adolescents with morbid obesity.

OBJECTIVE: Morbid obesity is the fastest growing subcategory of childhood obesity, associated with an increased health risk that persists into adulthood. There is an urgent need to develop multifaceted interventions that target initial and long-term lifestyle changes. This review investigates the effects of multidisciplinary interventions on weight loss and health outcomes in children and adolescents with morbid obesity. The influence of age, gender and family participation on health outcomes and intensive treatment alternatives are explored. METHODS: The review includes 16 studies conducted between 1995 and 2017. Studies examined youth with morbid obesity, 4-18 years old, undergoing multidisciplinary treatment. RESULTS: All studies found a reduction in body mass index (BMI or z-score) and if measured, cardiovascular risk factors. Physical activity, nutrition education, behavioural modification and family involvement are commonly included treatment components and have improved weight loss and health-related outcomes. However, initial weight loss was often not sustainable, despite the favourable interventional effect on cardiometabolic risk markers. Weight loss was prolonged in younger children and among the male sex. CONCLUSIONS: There is not a 'one-size-fits-all' treatment approach, and matched care to personal needs is preferable. The integration of a chronic care approach is critical for the successful adaption of sustainable health behaviours.

Association of Bariatric Surgery Using Laparoscopic Banding, Roux-en-Y Gastric Bypass, or Laparoscopic Sleeve Gastrectomy vs Usual Care Obesity Management With All-Cause Mortality.

Importance: Bariatric surgery is an effective and safe approach for weight loss and short-term improvement in metabolic disorders such as diabetes. However, studies have been limited in most settings by lack of a nonsurgical group, losses to follow-up, missing data, and small sample sizes in clinical trials and observational studies. Objective: To assess the association of 3 common types of bariatric surgery compared with nonsurgical treatment with mortality and other clinical outcomes among obese patients. Design, Setting, and Participants: Retrospective cohort study in a large Israeli integrated health fund covering 54% of Israeli citizens with less than 1% turnover of members annually. Obese adult patients who underwent bariatric surgery between January 1, 2005, and December 31, 2014, were selected and compared with obese nonsurgical patients matched on age, sex, body mass index (BMI), and diabetes, with a final follow-up date of December 31, 2015. A total of 33 540 patients were included in this study. Exposures: Bariatric surgery (laparoscopic banding, Roux-en-Y gastric bypass, or laparoscopic sleeve gastrectomy) or usual care obesity management only (provided by a primary care physician and which may include dietary counseling and behavior modification). Main Outcomes and Measures: The primary outcome, all-cause mortality, matched and adjusted for BMI prior to surgery, age, sex, socioeconomic status, diabetes, hyperlipidemia, hypertension, cardiovascular disease, and smoking. Results: The study population included 8385 patients who underwent bariatric surgery (median age, 46 [IQR, 37-54] years; 5490 [65.5%] women; baseline median BMI, 40.6 [IQR, 38.5-43.7]; laparoscopic banding [n = 3635], gastric bypass [n = 1388], laparoscopic sleeve gastrectomy [n = 3362], and 25 155 nonsurgical matched patients (median age, 46 [IQR, 37-54] years; 16 470 [65.5%] women; baseline median BMI, 40.5 [IQR, 37.0-43.5]). The availability of follow-up data was 100% for all-cause mortality. There were 105 deaths (1.3%) among surgical patients during a median follow-up of 4.3 (IQR, 2.8-6.6) years (including 61 [1.7%] who underwent laparoscopic banding, 18 [1.3%] gastric bypass, and 26 [0.8%] sleeve gastrectomy), and 583 deaths (2.3%) among nonsurgical patients during a median follow-up of 4.0 (IQR, 2.6-6.2) years. The absolute difference was 2.51 (95% CI, 1.86-3.15) fewer deaths/1000 person-years in the surgical vs nonsurgical group. Adjusted hazard ratios (HRs) for mortality among nonsurgical vs surgical patients were 2.02 (95% CI, 1.63-2.52) for the entire study population; by surgical type, HRs were 2.01 (95% CI, 1.50-2.69) for laparoscopic banding, 2.65 (95% CI, 1.55-4.52) for gastric bypass, and 1.60 (95% CI, 1.02-2.51) for laparoscopic sleeve gastrectomy. Conclusions and Relevance: Among obese patients in a large integrated health fund in Israel, bariatric surgery using laparoscopic banding, gastric bypass, or laparoscopic sleeve gastrectomy, compared with usual care nonsurgical obesity management, was associated with lower all-cause mortality over a median follow-up of approximately 4.5 years. The evidence of this association adds to the limited literature describing beneficial outcomes of these 3 types of bariatric surgery compared with usual care obesity management alone.