Effects of weight loss intervention on anxiety, depression and quality of life in women with severe obesity and polycystic ovary syndrome.

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women that is associated with an increased risk of anxiety and depression and with a lower health-related quality of life (HRQoL). PCOS is closely associated with obesity, which per se can lead to symptoms of anxiety and depression and lower HRQoL. The first-line treatment for PCOS is weight loss through lifestyle intervention, which has been shown to improve all symptoms of the syndrome. The aim of this study was to investigate symptoms of anxiety and depression and HRQoL in women with severe obesity (BMI ≥ 35) with and without PCOS, and to evaluate the effect of a one-year structured weight loss intervention. A total of 246 women with severe obesity (PCOS n = 63, non-PCOS n = 183) were included. The comprehensive psychopathological rating scale self-rating scale for affective symptoms (CPRS-S-A) and the short form-36 (SF-36) were used to assess symptoms of anxiety and depression and HRQoL. In total 72 women of the 246 women with severe obesity completed a one-year weight loss programme and were followed up and compared with baseline data. In women with severe obesity, there were no differences in symptoms of anxiety and depression and HRQoL between women with and without PCOS at baseline. Clinically relevant anxiety symptoms were present in 71.3% (PCOS) and 65.6% (non-PCOS), and depression symptoms were present in 56.4% (PCOS) and 52.2% (non-PCOS). Significant weight loss improved physical HRQoL in all women, but reduced symptoms of anxiety and depression only in women without PCOS. There were no differences when comparing the changes between the groups. Women with severe obesity are severely affected by symptoms of anxiety and depression, independent of PCOS. Weight loss improved symptoms of anxiety and depression in women without PCOS, but there were no differences between groups in change from baseline to follow-up.Trial registration number: Clinical trial.gov: NCT01319162, March 18, 2011. Date of registration and enrolment of the first subject September 2011.

A prospective 12-month structured weight loss intervention in women with severe obesity and polycystic ovary syndrome: Impact of weight loss on eating behaviors.

INTRODUCTION: The knowledge regarding eating behavior and disorders in women with polycystic ovary syndrome (PCOS) and severe obesity is limited. This study aimed to assess eating behavior and lifestyle factors in women with severe obesity (BMI ≥35 kg/m2), with and without PCOS, and the effect of weight loss on these behaviors. MATERIAL AND METHODS: A prospective clinical trial with participants screened for PCOS using National Institutes of Health criteria. Participants completed the Food Frequency Questionnaire, International Physical Activity Questionnaire, Three-Factor Eating Questionnaire, and Questionnaire of Eating and Weight Patterns-revised, and were evaluated regarding binge eating disorder using DSM-5 criteria before and after a 12-month weight loss intervention. CLINICALTRIALS: gov: NCT01319162. RESULTS: 246 women were included (PCOS n = 63, age 33.0 ± 8.4, BMI 39.9 ± 4.7; non-PCOS n = 183, age 37.7 ± 8.7, BMI 39.6 ± 4.3). Women with PCOS showed elevated baseline scores in cognitive restraint eating (50.0 [33.3-63.2]) compared to women without PCOS (38.9 [27.8-55.6]; p = 0.012). No differences were observed between groups in emotional and uncontrolled eating. In both groups, cognitive restraint eating was negatively correlated with energy intake (PCOS: r = -0.315, p < 0.05; non-PCOS: r = -0.214, p < 0.001), while uncontrolled eating displayed a positive correlation with energy intake (PCOS: r = 0.263, p = 0.05; non-PCOS: r = 0.402, p < 0.001). A positive correlation was found between emotional eating and energy intake only in women without PCOS (r = 0.400, p < 0.001). Baseline self-reported energy intake and physical activity did not differ between groups. At 12-month follow-up, women with PCOS reported reduced fat intake. Women without PCOS reported reduced energy intake, carbohydrates and sugar, increased protein, reduced scores for emotional and uncontrolled eating, and heightened scores for cognitive restraint eating. Comparing changes from baseline to follow-up, differences were found between groups in cognitive restraint, intake of fat, carbohydrates, and sugar. The mean weight loss was 12-14 kg, with no between-group difference (p = 0.616). CONCLUSIONS: Women with severe obesity and PCOS showed elevated cognitive restraint eating behaviors compared to women without PCOS. Although significant weight loss was seen in both groups, alterations in eating behavior more favorable for weight loss were only seen in women without PCOS.

Patient Satisfaction and Healthcare Utilization with the Transition to Virtual Care in a Multidisciplinary Bariatric Program.

BACKGROUND: The COVID-19 pandemic saw an acceleration in virtual-visits (VV) for healthcare delivery. However, the impact of virtual care in metabolic/bariatric surgery (MBS) programs is not well described. METHODS: Appointment data from three time-points: pre-pandemic (1/1/19-3/15/20, n = 19,290), pandemic (3/16/20-10/31/21, n = 29,459) and current-state (11/1/21-12/31/2022, n = 24,270) was retrieved in our multi-hospital ambulatory MBS program. Appointments were grouped by health care provider (HCP) (MD, dietician, and psychologist) and type (VV and in-person). Surveys assessing patient satisfaction were distributed electronically. All pre-op and post-op appointment data was analyzed for the time-points above. Appointment completion rates and patient reported preferences were described. RESULTS: Our data showed an increase in scheduled VV from 0.5% for all HCP visits to 81% during the pandemic and a current VV visit of 77%. The number of completed VV increased for all HCPs, most prominently for dieticians. Parallel to this, the percentage of no-show visits also improved for all HCP, with MDs having the lowest no-show rate currently. Survey data revealed 89% of patients experience added benefits with VV and > 90% reported their VV experience as very good. VV were preferred over in-person visits for psychologists and dietitians (> 61%), but the majority preferred to see MDs in-person (70%). CONCLUSIONS: Our findings reveal significant changes in healthcare utilization trends since the transition to virtual care. While overall satisfaction with virtual care is high, most patients prefer in-person visits with MDs. Thus, multi-disciplinary MBS care can be performed effectively using a hybrid model to ensure efficient distribution of resources.

Effects of Additional Protein Intake on Lean Body Mass in Patients Undergoing Multimodal Treatment for Morbid Obesity.

(1) Multimodal treatment is a standard treatment for patients with obesity. However, weight loss also leads to reductions in fat-free mass. The aim was to investigate whether additional protein intake contributes to better preservation of lean body mass (LBM). (2) A total of 267 obesity patients (age 45.8 years; BMI 47.3 kg/m2) were included in this analysis. For the first 12 weeks of the program, patients were given a formula-based diet of 800-1000 kcal per day. Patients were divided into a control group (CG) (n = 148) and a protein group (PG) (n = 119). The PG was characterized by an additional protein intake with the aim of consuming 1.5 g of protein per kilogram of normalized body weight, whereas the CG had a protein intake of 1 g/kg/d. Bioelectrical impedance analysis was performed at the beginning (t0) and after 12 weeks (t1) of the program. (3) There were no significant differences between the groups with respect to weight loss (p = 0.571). LBM was also significantly reduced in both groups, without significant differences between CG and PG. (4) Increased protein intake had no significant effect on body composition of morbidly obese patients during a 12-week formula-based diet and multimodal treatment.

Developing a Decision Aid for Clinical Obesity Services in the Real World: the DACOS Nationwide Pilot Study.

PURPOSE: The purpose of this study is to develop a decision aid tool using "real-world" data within the Australian health system to predict weight loss after bariatric surgery and non-surgical care. MATERIALS AND METHODS: We analyzed patient record data (aged 16+years) from initial review between 2015 and 2020 with 6-month (n=219) and 9-/12-month (n=153) follow-ups at eight clinical obesity services. Primary outcome was percentage total weight loss (%TWL) at 6 months and 9/12 months. Predictors were selected by statistical evidence (p<0.20), effect size (±2%), and clinical judgment. Multiple linear regression and bariatric surgery were used to create simple predictive models. Accuracy was measured using percentage of predictions within 5% of the observed value, and sensitivity and specificity for predicting target weight loss of 5% (non-surgical care) and 15% (bariatric surgery). RESULTS: Observed %TWL with bariatric surgery vs. non-surgical care was 19% vs. 5% at 6 months and 22% vs. 5% at 9/12 months. Predictors at 6 months with intercept (non-surgical care) of 6% include bariatric surgery (+11%), BMI>60 (-3%), depression (-2%), anxiety (-2%), and eating disorder (-2%). Accuracy, sensitivity, and specificity were 58%, 69%, and 56%. Predictors at 9/12 months with intercept of 5% include bariatric surgery (+15%), type 2 diabetes (+5%), eating disorder (+4%), fatty liver (+2%), atrial fibrillation (-4%), osteoarthritis (-3%), sleep/mental disorders (-2-3%), and ≥10 alcohol drinks/week (-2%). Accuracy, sensitivity, and specificity were 55%, 86%, and 53%. CONCLUSION: Clinicians may use DACOS to discuss potential weight loss predictors with patients after surgery or non-surgical care.

Long-term impact of weight loss in people with class II obesity on the overall burden of disease: Evidence from the National Health Screening Cohort in Korea.

BACKGROUND: Obesity is known to increase overall disease burden but does obesity management actually help reduce disease burden? OBJECTIVES: To investigate the effects of weight loss on disease burden in people with obesity using the National Health Insurance Service-Health Screening Cohort (NHIS-HEALS) in Korea. SETTING: Pure longitudinal observational study using Nationwide cohort database. METHODS: Out of 514,866 NHIS-HEALS cohort, participants with class II obesity in Asia-Pacific region (30 ≤ body mass index [BMI] < 35) who underwent health check-up provided by NHIS during 2003-2004 (index date) were included. All final participants continued to receive a total of 5 biennial health check-ups over the next 10 years without missing. A group-based trajectory model (GBTM) was used to categorize subjects based on 10-year BMI change patterns. The changes of co-morbidities, healthcare resource utilization, and medical cost were analyzed. RESULTS: The final study subjects (9857) were categorized into 3 trajectory clusters based on the pattern of BMI (kg/m2) change: maintenance (57.35%) with an average change of -.02 ± .06, loss (38.65%) with -.04 ± .08, and substantial loss (4.0%) with -.10 ± .18. The annual increases in the number of co-morbidities per subject in each cluster were .18, .18, and .16 (all P < .001), respectively. The increase of healthcare resource utilization over time was lowest for the substantial loss compared to maintenance and loss. With each passing year, the average annual total healthcare cost increased by ₩21,200 ($16.48, P = .034) and ₩10,500 ($8.16, P = .498) in the maintenance and loss, respectively, but decreased by ₩62,500 ($48.59, P = .032) in the substantial loss. CONCLUSIONS: Weight loss in people with obesity was associated with a reduced burden of disease, as evidenced by lower co-morbidity, healthcare resource utilization rate, and decreased medical costs. This study highlights the potential positive long-term impact on Korean society when actively managing weight in individuals with obesity.

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.

Factors associated with weight loss and health gains in a structured lifestyle modification programme for adults with severe obesity: a prospective cohort study.

Background: Individual responses to behavioural weight loss interventions can vary significantly, and a better understanding of the factors associated with successful treatment might help to target interventions for those who will benefit the most. We sought to identify demographic and clinical characteristics that predicted intervention "success" (defined as ≥5% weight loss) and other health gains in patients with severe obesity attending a ten-week structured lifestyle modification programme. Methods: We conducted a prospective cohort study of all 1122 patients (751 (66.9%) female, mean age 47.3 ± 11.9 years, mean body mass index (BMI) 46.7 ± 7.8 kgm-2) referred from our hospital-based obesity clinic, who started the structured lifestyle programme between 2012-2019. We compared routine clinical measures such as weight, fitness, blood pressure, lipids and HbA1c at baseline and follow-up. We also used validated questionnaires to quantify anxiety, depression and health-related quality of life. Results: Of 1122 patients who started, 877 (78.2%) completed the programme and attended for follow up. Of these, 12.8% lost ≥5% body weight. The amount of weight lost was a strong and consistent predictor of improvements in metabolic, cardiovascular, and mental health, even after adjusting for age, sex, programme attendance and baseline fitness. Older age, male sex, being physically active and having lower anxiety and depression scores at baseline predicted greater weight loss. Younger age, depression and longer wait time to start the intervention were associated with drop-out. Conclusions: In adults with severe obesity completing a structured lifestyle modification programme, older age and good mental health were associated with programme completion and attaining ≥5% weight loss. The magnitude of weight lost was a strong predictor of improvements in cardiovascular, metabolic and mental health associated with programme completion.

[From morbid obesity to complex obesity: somato-psychic issues]. / De l'obésité morbide à l'obésité complexe : des enjeux somato-psychiques.

Complex obesity is a chronic, multifactorial pathology. These repercussions (respiratory insufficiency, hypoventilation syndrome, cardiac insufficiency, loss of functional autonomy and mobility with a tendency to grabatization, depression, behavioral disorders) directly sustain the disease. Access to care is virtually impossible for them outside specialized obesity centers (CSO) and specialized medical and rehabilitation care (SMR). We need to support healthcare teams by analyzing their practices, including those of expert patients, to ensure that complex obesity is treated with the humanity it requires.

[Reception and initial assessment when caring for a person with severe obesity]. / Accueil et bilan initial lors de la prise en charge d'une personne en situation d'obésité sévère.

In France, there are 37 specialist obesity treatment centres (CSOs), located in mainland and overseas France. Attached to public or private health establishments, they have two main missions, which they carry out within the framework of national specifications: the multidisciplinary management of severe or complex obesity, and the organisation, coordination and development of the regional obesity care network. This article illustrates the practice of the Caen Normandy CSO.

Poor dental service utilization in those with clinically severe obesity: A neglected issue with solutions needed.

Data linking body mass index (BMI) and dental service utilization with oral and general health, quality of life, wellbeing, and mental health are lacking. Adult patients with clinically severe obesity attending a hospital-based obesity service in Greater Western Sydney were invited to participate in a cross-sectional survey that collected data on dental utilization and visiting patterns, dental anxiety, and oral health-related quality of life (OHRQoL). General health data were obtained from participants' medical records. Of the 82 individuals who consented to participate, 81 (98.8%) completed the study questionnaire, and 74 (91.3%) answered additional screening questions related to their general wellbeing and mental health. Of the participants, 50 (61.7%) reported that their last dental visit was more than 1 year ago, 43 (53.1%) visited only as needed and 22 (27.2%) participants reported favourable dental visiting patterns. Twenty-four (29.6%) participants reported high levels of dental anxiety, and low levels of OHRQoL compared with national data. Screening questions suggested low general wellbeing and poor mental health in this patient cohort. Within this group, BMI was not significantly correlated with any of the variables of dental service utilization, dental anxiety, OHRQoL, wellbeing, or mental health (p > .05). There was a negative correlation between dental anxiety and dental utilization (p < .05). Patients with clinically severe obesity reported poor dental utilization, low OHRQoL, and high levels of dental anxiety. This study highlighted the frequency of medical complications, lack of wellbeing, and poor mental health, which were evident in this cohort and may complicate dental management.

Effect of reverse Trendelenburg position and positive pressure ventilation on safe non-hypoxic apnea period in obese, a randomized-control trial.

PURPOSE: There is an elevated incidence of hypoxemia during the airway management of the morbidly obese. We aimed to assess whether optimizing body position and ventilation during pre-oxygenation allow a longer safe non-hypoxic apnea period (SNHAP). METHODS: Fifty morbidly obese patients were recruited and randomized for this study. Patients were positioned and preoxygenated for three minutes in the ramp position associated with spontaneous breathing without additional CPAP or PEEP (RP/ZEEP group) or in the reverse Trendelenburg position associated with pressure support ventilation mode with pressure support of 8 cmH2O and an additional 10 cmH2O of PEEP while breathing spontaneously (RT/PPV group) according to randomization. RESULTS: The SNHAP was significantly longer in the RT/PPV group (258.2 (55.1) vs. 216.7 (42.3) seconds, p = 0.005). The RT/PPV group was also associated to a shorter time to obtain a fractional end-tidal oxygen concentration (FEtO2) of 0.90 (85.1(47.8) vs 145.3(40.8) seconds, p < 0.0001), a higher proportion of patients that reached the satisfactory FEtO2 of 0.90 (21/24, 88% vs. 13/24, 54%, p = 0.024), a higher FEtO2 during preoxygenation (0.91(0.05) vs. 0.89(0.01), p = 0.003) and a faster return to 97% oxygen saturation after ventilation resumption (69.8 (24.2) vs. 91.4 (39.2) seconds, p = 0.038). CONCLUSION: In the morbidly obese population, RT/PPV, compared to RP/ZEEP, lengthens the SNHAP, decreases the time to obtain optimal preoxygenation conditions, and allows a faster resuming of secure oxygen saturation. The former combination allows a more significant margin of time for endotracheal intubation and minimizes the risk of hypoxemia in this highly vulnerable population. TRIAL REGISTRATION: NCT02590406, 29/10/2015.

'It's been a lifelong thing for me': parents' experiences of facilitating a healthy lifestyle for their children with severe obesity.

OBJECTIVE: For parents and guardians, assisting children/adolescents with severe obesity to lose weight is often a key objective but a complex and difficult challenge. Our aim in this study was to explore parents' (and guardians') perspectives on the challenges they have faced in assisting their children/adolescents with severe obesity to lead a healthy lifestyle. METHODS: Thirteen parents/guardians were interviewed from a pool of families who had been referred but did not engage between 2016 and 2018 (N = 103), with the Perth Children's Hospital Healthy Weight Service, a clinical obesity program for children/adolescents (parent age M = 43.2 years, children age M = 10.3 years). Using semi-structured interviews and thematic analysis, we identified 3 broad themes. RESULTS: Parental weight-related factors reflected parents' own lifelong obesity narrative and its effect on their own and their families' ability to live a healthy lifestyle. Perceived inevitability of obesity in their child reflected parents' feelings that the obesity weight status of their children/adolescent was a persistent and overwhelming problem that felt 'out of control'. Lastly, parents reported challenges getting medical help stemming from co-morbid medical diagnosis in their child/adolescent, and difficulties with medical professionals. CONCLUSION: This study demonstrates that parents face challenges in supporting healthy lifestyle for children/adolescents with severe obesity due to parents own internal weight biases and their negative experiences within the healthcare system when seeking help.

Health-related quality of life in children under treatment for overweight, obesity or severe obesity: a cross-sectional study in the Netherlands.

BACKGROUND: It is unknown whether weight class is associated with impairment of health-related quality of life (HRQOL) for children in the Netherlands. The aim of this study was to explore generic and weight-specific HRQOL in a clinical cohort of children with overweight, obesity or severe obesity aged 5-19 years in the Netherlands. METHODS: 803 children from three clinical cohorts participated: mean age 11.5 (SD 2.9) years, 61.1% girls. The influence of weight class was explored in a subgroup of 425 children (25.2% with overweight, 32.5% obesity and 42.3% severe obesity), of whom the exact International Obesity Task Force (IOTF) BMI class was known. Generic HRQOL was measured by the PedsQL child report. Weight-specific HRQOL was measured by the IWQOL-Kids child or parent report. Average total, subscale and item scores were reported and the influence of the IOTF BMI class analyzed by multiple linear regression, corrected for age and sex. RESULTS: Children with severe obesity had lower generic and weight-specific HRQOL scores than those with obesity or overweight. IOTF BMI class was negatively associated with item scores from all subscales, especially physical, social and emotional functioning. Children with overweight reported similar HRQOL total, subscale and item scores to children with obesity. CONCLUSIONS: In the Netherlands, children treated for overweight, obesity or severe obesity experience problems on the majority of items within all subscales of generic and weight-specific HRQOL. Children with severe obesity especially report significantly more challenges due to their weight than children with obesity or overweight.

Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL).

INTRODUCTION: Behavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m2 or ≥35.0 kg/m2 with obesity-related comorbidity), leading to moderate weight loss which often cannot be maintained in the long term. Because weight loss depends on patients' use of weight management skills, it is important to support them in daily life. In an ecological momentary intervention design, this clinical trial aims to adapt, refine and evaluate a personalised cognitive-behavioural smartphone application (app) in BWL treatment to foster patients' weight management skills use in everyday life. It is hypothesised that using the app is feasible and acceptable, improves weight loss and increases skills use and well-being. METHODS AND ANALYSIS: In the pilot phase, the app will be adapted, piloted and optimised for BWL treatment following a participatory patient-oriented approach. In the subsequent single-centre, assessor-blind, exploratory randomised controlled trial, 90 adults with SO will be randomised to BWL treatment over 6 months with versus without adjunctive app. Primary outcome is the amount of weight loss (kg) at post-treatment (6 months), compared with pretreatment, derived from measured body weight. Secondary outcomes encompass feasibility, acceptance, weight management skills use, well-being and anthropometrics assessed at pretreatment, midtreatment (3 months), post-treatment (6 months) and 6-month follow-up (12 months). An intent-to-treat linear model with randomisation arm, pretreatment weight and stratification variables as covariates will serve to compare arms regarding weight at post-treatment. Secondary analyses will include linear mixed models, generalised linear models and regression and mediation analyses. For safety analysis (serious) adverse events will be analysed descriptively. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the University of Leipzig (DE-21-00013674) and notified to the Federal Institute for Drugs and Medical Devices. Study results will be disseminated through peer-reviewed publications. REGISTRATION: This study was registered at the German Clinical Trials Register (DRKS00026018), www.drks.de. TRIAL REGISTRATION NUMBER: DRKS00026018.

Diastolic function and cardiovascular risk among patients with severe obesity referred to a lifestyle-program - a pilot study.

Objectives. Severe obesity is associated with a high risk of comorbidities and alterations of cardiac structure and function. The primary aim of the study was to investigate the proportion of diastolic dysfunction (DD) at baseline, and changes in cardiac function from baseline (T1) to 6 months follow-up (T2) among participants with severe obesity attending a lifestyle-intervention. The secondary aim was to explore changes in body mass index (BMI), physical fitness (VO2peak) and cardiovascular risk from T1 to T2 and 12 months follow-up (T3).Design. This was an open single-site prospective observational study. Patients were recruited from an obesity clinic to a lifestyle-intervention consisting of three 3-weeks intermittent stays over 12-months period. Echocardiography was performed at T1 and T2 and BMI, VO2peak and cardiovascular risk measured at T1, T2 and T3.Results. Fifty-six patients were included (mean age 45.1 years; BMI 41.9). Six of 52 patients (12%) had grade 1 DD at T1, while five subjects had DD at T2. E/A ratio (11%, p = .005) and mitral deceleration time (9%, p = .014) were improved at T2. A reduction in BMI (-1.8, p < .001) and improvement in VO2peak (1.6 mL/kg min, p = .026) were assessed at T2 and this improvement persisted at T3. The total cardiovascular risk score was not significantly changed.Conclusion. The patients with severe obesity had low prevalence of DD. For all participants, an improvement in diastolic parameters, and an important initial weight loss was observed.Clinical Trial number: NCT02826122.

Swallowable Intragastric Balloon: First Consecutive Experience in Argentina.

Background: Swallowable balloons are innovative devices for the treatment of obesity. Endoscopy or anesthesia for implantation is not required. They are generally well tolerated and experience reports satisfactory results in relation to weight loss. The objective of this study was to analyze the first experience with the implementation of a swallowable balloon in Argentina. Methods: It is a descriptive retrospective observational study on the treatment of obesity in patients who underwent swallowable balloons in Argentina, admitted to one center, in a period time of 12 months with a follow-up of 6 months. Results: A total of n = 153 patients were recruited between June 2021 and May 2022, 78% were women and 22% men. The average age was 39 years. Average body mass index was 29.5 kg/m2. Balloon implantation was performed with complete swallowing by the patients in 19.4% of the cases, swallowing with operator assistance in 55.5%, and swallowing with stylet assistance in 25%. The adverse effects reported were abdominal pain (80%), nausea (60%), vomiting (38%), headache (36%), gastroesophageal reflux (29%), constipation (11%), and diarrhea (7%). No deaths were reported. A mean 4-month weight loss of 12% was reported. Conclusion: Swallowable balloon for the treatment of obesity is effective, safe, and well tolerated. Adverse effects are not severe.