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Background In Canada, demand for multidisciplinary bariatric (obesity) care far outstrips capacity. Consequently, prolonged wait times exist that contribute to substantial health impairments. A supportive, educational, self-management intervention (with in-person and web-based versions) for patients wait-listed for bariatric care has already been implemented in Northern and Central Alberta, Canada, but its effectiveness is unknown. The objective of this trial is to evaluate the clinical and economic outcomes of two self-management programs of varying intensity that are currently in use. Methods We conducted a pragmatic, prospective, parallel-arm, randomized controlled trial of 651 wait-listed patients from two regional bariatric programs. Patients were randomized to (1) an in-person, group-based intervention (13 sessions; n  = 215) or (2) a web-based intervention (13 modules; n  = 225) or (3) control group (printed educational materials; n  = 211). After randomization, subjects had 3 months to review the content assigned to them (the intervention period) prior to bariatric clinic entry. The primary outcome was the proportion of patients achieving 5% weight loss at 9 months. Intention-to-treat two-way comparisons were performed and adjusted for baseline age, sex, site and body mass index. Results At baseline, mean age was 40.4 ± 9.8 years, mean weight was 134.7 ± 25.2 kg, mean body mass index was 47.7 ± 7.0 kg/m 2 and 83% of participants were female. A total of 463 patients (71%) completed 9 months follow-up. At least 5% weight loss was achieved by 24.2% of those in the in-person strategy, 24.9% for the web-based strategy and 21.3% for controls (adjusted p value = 0.26 for in-person vs. controls, 0.28 for web-based vs. controls, 0.96 for in-person vs. web-based). Absolute and relative (% of baseline) mean weight reductions were 3.7 ± 7.1 kg (2.7 ± 5.4%) for in-person strategy, 2.8 ± 6.7 kg (2.0 ± 4.8%) for web-based and 2.9 ± 8.8 kg (1.9 ± 5.9%) for controls ( p  > 0.05 for all comparisons). No between-group differences were apparent for any clinical or humanistic secondary outcomes. Total annual costs in Canadian dollars were estimated at $477,000.00 for the in-person strategy, $9456.78 for the web-based strategy and $2270.31 for provision of printed materials. Discussion Two different self-management interventions were no more effective and were more costly than providing printed education materials to severely obese patients. Our findings underscore the need to develop more potent interventions and the importance of comprehensively evaluating self-management strategies before widespread implementation. Trial registration ClinicalTrials.gov, NCT01860131 . Registered 17 May 2013.

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility. Obesity exacerbates the reproductive complications of PCOS; however, the management of obesity in women with PCOS remains a large unmet clinical need. Observational studies have indicated that bariatric surgery could improve the rates of ovulatory cycles and prospects of fertility; however, the efficacy of surgery on ovulation rates has not yet been compared with behavioural modifications and medical therapy in a randomised trial. The aim of this study was to compare the safety and efficacy of bariatric surgery versus medical care on ovulation rates in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. In this multicentre, open-label, randomised controlled trial, 80 women older than 18 years, with a diagnosis of PCOS based on the 2018 international evidence-based guidelines for assessing and managing PCOS, and a BMI of 35 kg/m2 or higher, were recruited from two specialist obesity management centres and via social media. Participants were randomly assigned at a 1:1 ratio to either vertical sleeve gastrectomy or behavioural interventions and medical therapy using a computer-generated random sequence (PLAN procedure in SAS) by an independent researcher not involved with any other aspect of the clinical trial. The median age of the entire cohort was 31 years and 79% of participants were White. The primary outcome was the number of biochemically confirmed ovulatory events over 52 weeks, and was assessed using weekly serum progesterone measurements. The primary endpoint included the intention-to-treat population and safety analyses were per-protocol population. This study is registered with the ISRCTN registry (ISRCTN16668711). Participants were recruited from Feb 20, 2020 to Feb 1, 2021. 40 participants were assigned to each group and there were seven dropouts in the medical group and ten dropouts in the surgical group. The median number of ovulations was 6 (IQR 3·5–10·0) in the surgical group and 2 (0·0–4·0) in the medical group. Women in the surgical group had 2.5 times more spontaneous ovulations compared with the medical group (incidence rate ratio 2·5 [95% CI 1·5–4·2], p<0·0007). There were more complications in the surgical group than the medical group, although without long-term sequelae. There were 24 (66·7%) adverse events in the surgical group and 12 (30·0%) in the medical group. There were no treatment-related deaths. Bariatric surgery was more effective than medical care for the induction of spontaneous ovulation in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. Bariatric surgery could, therefore, enhance the prospects of spontaneous fertility in this group of women. The Jon Moulton Charity Trust.

Background Despite growing evidence that bariatric/metabolic surgery powerfully improves type 2 diabetes (T2D), existing diabetes treatment algorithms do not include surgical options. Aim The 2nd Diabetes Surgery Summit (DSS-II), an international consensus conference, was convened in collaboration with leading diabetes organizations to develop global guidelines to inform clinicians and policymakers about benefits and limitations of metabolic surgery for T2D. Methods A multidisciplinary group of 48 international clinicians/scholars (75% nonsurgeons), including representatives of leading diabetes organizations, participated in DSS-II. After evidence appraisal (MEDLINE [1 January 2005–30 September 2015]), three rounds of Delphi-like questionnaires were used to measure consensus for 32 data-based conclusions. These drafts were presented at the combined DSS-II and 3rd World Congress on Interventional Therapies for Type 2 Diabetes (London, U.K., 28–30 September 2015), where they were open to public comment by other professionals and amended face-to-face by the Expert Committee. Results Given its role in metabolic regulation, the gastrointestinal tract constitutes a meaningful target to manage T2D. Numerous randomized clinical trials, albeit mostly short/midterm, demonstrate that metabolic surgery achieves excellent glycemic control and reduces cardiovascular risk factors. On the basis of such evidence, metabolic surgery should be recommended to treat T2D in patients with class III obesity (BMI ≥40 kg/m 2 ) and in those with class II obesity (BMI 35.0–39.9 kg/m 2 ) when hyperglycemia is inadequately controlled by lifestyle and optimal medical therapy. Surgery should also be considered for patients with T2D and BMI 30.0–34.9 kg/m 2 if hyperglycemia is inadequately controlled despite optimal treatment with either oral or injectable medications. These BMI thresholds should be reduced by 2.5 kg/m 2 for Asian patients. Conclusions Although additional studies are needed to further demonstrate long-term benefits, there is sufficient clinical and mechanistic evidence to support inclusion of metabolic surgery among antidiabetes interventions for people with T2D and obesity. To date, the DSS-II guidelines have been formally endorsed by 45 worldwide medical and scientific societies. Health care regulators should introduce appropriate reimbursement policies.

Randomised controlled trials have shown that bariatric surgery is more effective than conventional treatment for the short-term control of type-2 diabetes. However, published studies are characterised by a relatively short follow-up. We aimed to assess 5 year outcomes from our randomised trial designed to compare surgery with conventional medical treatment for the treatment of type 2 diabetes in obese patients. We did our open-label, randomised controlled trial at one diabetes centre in Italy. Patients aged 30–60 years with a body-mass index of 35 kg/m2 or more and a history of type 2 diabetes lasting at least 5 years were randomly assigned (1:1:1), via a computer-generated randomisation procedure, to receive either medical treatment or surgery by Roux-en-Y gastric bypass or biliopancreatic diversion. Participants were aware of treatment allocation before the operation and study investigators were aware from the point of randomisation. The primary endpoint was the rate of diabetes remission at 2 years, defined as a glycated haemaglobin A1c (HbA1c) concentration of 6·5% or less (≤47·5 mmol/mol) and a fasting glucose concentration of 5·6 mmol/L or less without active pharmacological treatment for 1 year. Here we analyse glycaemic and metabolic control, cardiovascular risk, medication use, quality of life, and long-term complications 5 years after randomisation. Analysis was by intention to treat for the primary endpoint and by per protocol for the 5 year follow-up. This study is registered with ClinicalTrials.gov, number NCT00888836. Between April 27, 2009, and Oct 31, 2009, we randomly assigned 60 patients to receive either medical treatment (n=20) or surgery by gastric bypass (n=20) or biliopancreatic diversion (n=20); 53 (88%) patients completed 5 years' follow-up. Overall, 19 (50%) of the 38 surgical patients (seven [37%] of 19 in the gastric bypass group and 12 [63%] of 19 in the bilipancreatic diversion group) maintained diabetes remission at 5 years, compared with none of the 15 medically treated patients (p=0·0007). We recorded relapse of hyperglycaemia in eight (53%) of the 15 patients who achieved 2 year remission in the gastric bypass group and seven (37%) of the 19 patients who achieved 2 year remission in the biliopancreatic diversion group. Eight (42%) patients who underwent gastric bypass and 13 (68%) patients who underwent biliopancreatic diversion had an HbA1c concentration of 6·5% or less (≤47·5 mmol/mol) with or without medication, compared with four (27%) medically treated patients (p=0·0457). Surgical patients lost more weight than medically treated patients, but weight changes did not predict diabetes remission or relapse after surgery. Both surgical procedures were associated with significantly lower plasma lipids, cardiovascular risk, and medication use. Five major complications of diabetes (including one fatal myocardial infarction) arose in four (27%) patients in the medical group compared with only one complication in the gastric bypass group and no complications in the biliopancreatic diversion group. No late complications or deaths occurred in the surgery groups. Nutritional side-effects were noted mainly after biliopancreatic diversion. Surgery is more effective than medical treatment for the long-term control of obese patients with type 2 diabetes and should be considered in the treatment algorithm of this disease. However, continued monitoring of glycaemic control is warranted because of potential relapse of hyperglycaemia. Catholic University of Rome.

Bariatric surgery is an effective therapy for obesity, hypertension and type 2 diabetes mellitus that is refractory to maximal medical therapy. Results of long-term cohort studies and emerging evidence from randomized clinical trials have revealed that, in addition to its beneficial effects on weight reduction, blood pressure and metabolic control, bariatric surgery might reduce the incidence and long-term progression of chronic kidney disease (CKD). Preclinical studies have provided experimental verification that bariatric surgery improves key parameters of kidney injury at the functional, structural and ultrastructural levels, and effects a programme of transcriptomic change in the kidney that is coherent with injury resolution. Multiple mechanisms explain these observations, ranging from predictable aspects of risk-factor reduction to some novel and unforeseen renoprotective benefits of surgery. Current evidence therefore supports the judicious use of bariatric surgery to treat patients with obesity, diabetes and CKD. Optimizing the benefits of surgery requires careful patient selection and consideration of how to identify and mitigate some of the challenges associated with these surgical procedures.Obesity is a risk factor for the progression of chronic kidney disease. In this Review, the authors discuss the renoprotective effects of bariatric surgery and its potential as a therapeutic intervention in patients with chronic kidney disease and obesity.

Bariatric surgery is an effective treatment for moderate-to-severe obesity, however, reliable vascular access during the perioperative period remains a challenge in this population. This study compared the safety and efficacy of midline catheters (MCs) and long peripheral catheters (LPCs) in patients who underwent bariatric surgery. This single-blind, randomised controlled trial was conducted at a tertiary acute hospital between September 2023 and January 2024. A totol of 224 patients were assigned to receive either MC or LPC. The primary outcome was catheter failure; secondary outcomes included insertion attempts, time to insert the device, indwelling time, complications, requirements for additional vascular access devices, and patient satisfaction. The incidence of catheter failure was significantly lower in the MCs group (10.71%) than in the LPCs group (20.54%; odds ratio [OR] 0.46; 95% confidence interval [CI], 0.22–0.99; P  = 0.043). Additionally, MCs had longer median indwelling times (7 d vs. 5 d; P  < 0.001), fewer complications (13.39% vs. 27.68%; OR 0.40; 95% CI, 0.20–0.80; P  = 0.008), and required fewer additional devices (4.46% vs. 16.07%; OR 0.24; 95% CI, 0.09–0.68; P  = 0.004). These findings suggest that MCs are a superior choice for vascular access devices in patients undergoing bariatric surgery. Trial registration : Trial registered at ClinicalTrials.gov (NCT06031545 11/09/2023).

People with severe obesity who undergo a total knee arthroplasty (TKA) for osteoarthritis (OA) are at higher risk of short-term and long-term complications compared with people with reference (<30) body mass index (BMI; weight in kilograms divided by height in meters squared). It is not known whether weight loss before TKA modifies this risk. To determine whether outcomes are improved by undergoing bariatric surgery before TKA in people with BMI greater than or equal to 35 and end-stage OA. This parallel-group, assessor-blinded, randomized clinical trial was conducted between May 2012 and June 2020 with a minimum follow-up of 12 months after TKA. TKA was performed at a tertiary referral university-affiliated public hospital, and bariatric surgery was performed at a private hospital facility and a university-affiliated private practice. Data analysis was performed from February to July 2021. Bariatric surgery compared with usual weight management advice (treatment as usual [TAU]) in people scheduled for TKA. The primary outcome was complications of TKA measured by a composite of death from any cause, perioperative or postoperative complications resulting in a discharge delay, unplanned procedure, or readmission for at least 12 months after TKA. Secondary outcomes included hospital bed day utilization, anthropomorphic measures, and patient-reported outcomes. Eighty-two patients waiting for TKA were randomized to undergo bariatric surgery (41 patients) or TAU (41 patients). Of the 82 participants, 66 (80.5%) were women, the mean (SD) age was 57.8 (4.9) years, and the mean (SD) BMI was 43.8 (5.5). Thirty-nine participants (95.1%) in the intervention group underwent laparoscopic adjustable gastric banding, and 29 (70.7%) subsequently underwent TKA. Thirty-nine patients (95.1%) in the TAU group underwent TKA. Six patients (14.6%) in the intervention group incurred the primary outcome (median follow-up, 24 months), compared with 15 (36.6%) in the TAU group (median follow-up, 27 months) (difference, 22.0%; 95% CI, 3.7% to 40.3%; P = .02). The between-group difference in BMI at 12 months was -6.32 (95% CI, -7.90 to -4.50; P < .001) in favor of the intervention group. TKA was declined by 12 participants (29.3%) in the intervention group because of symptom improvement, whereas 2 participants (4.9%) in the TAU group declined TKA (difference, 24.4%; 95% CI, 9.0% to 39.8%; P = .003). Weight loss following bariatric surgery reduced the risk of complications of TKA in people with BMI greater than or equal to 35. Significantly fewer participants required TKA following weight loss, contributing to this finding. Australian New Zealand Clinical Trials Registry Number: ACTRN12611001178932.

Abstract Introduction: Obesity is associated with reduced life expectancy and various comorbidities. Surgical interventions are effective but accompanied by the risk of serious complications. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). A randomized, sham-controlled study comparing both procedures has not been undertaken so far. Methods: We performed a randomized, patient- and assessor-blinded, controlled trial comparing weight loss in IB versus DJBL versus a sham procedure (2:2:1 ratio). Patients with a BMI >35 kg/m2 or >30 with obesity-related comorbidities were included. The IB was removed after 6 months and the DJBL after 12 months. The main objective was successful weight loss (>10% from baseline) 12 months after explantation of the devices. Secondary outcomes were changes in comorbidities, quality of life, and complications. Results: Thirty-three patients were randomized. Recruitment has to be stopped suddenly in after the DJBL device lost its CE mark in Europe. In all, 11 patients received DJBL, 15 IB, and 7 were allocated to the sham group. Blinding was feasible in all patients. Weight decreased from baseline until explantation (DJBL: 129.4 ± 28.3 kg to 107.4 ± 16.7 kg; IB: 118.3 ± 22.8 kg to 107.4 ± 25.7 kg; sham: 134.6 ± 18.0 kg to 131.2 ± 14.3 kg), but patients regained weight almost to the baseline level 12 months after explantation. Only 1 patient in IB group reached the primary endpoint. Severe device-related complications were very rare. Conclusion: Endoscopic bariatric procedures failed to achieve effective weight loss 12 months after explantation of the devices. The results of this trial need to be interpreted with caution due to its early termination.

Background Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity. Methods Consecutive patients with morbid obesity treated by LSG at our department were evaluated. Patients enrolled in the study were randomized into group I (LSG begins the division 2 cm from the pylorus) and group II (LSG begins the division 6 cm from the pylorus). The primary outcome measure was the percent of excess weight loss (% EWL); secondary outcomes included postoperative morbidity and mortality and improvement of comorbidity. Results One hundred five patients (79 (75.2 %) were females) were randomized into two groups of (GI) 52 patients and (GII) 53 patients. In group I, the mean % EWL was 51.8 ± 13.9, 63.8 ± 16.1 and 71.8 ± 12; however, in group II, the mean % EWL was 38.3 ± 10.9, 51.9 ± 13.6 and 61 ± 11.1 at 6, 12, and 24 months, respectively ( P  = 0.0001, 0.0001, 0.003). There was weight regain after 2 years in five patients in group II and only one patient in group I ( P  = 0.09). There was no significant difference between both group as regards gastric leakage, vomiting or GER. There was significant improvement in comorbidity after LSG in both groups, but no significant difference between them. Hospital mortality occurred in group II in one case as a result of gastric leakage. Conclusions LSG is a safe and effective procedure with good short-term outcome. Increasing the size of the resected antrum is associated with better weight loss without increasing the rate of complications significantly.

BackgroundAmong the controversial points in laparoscopic sleeve gastrectomy (LSG) is how much of the antrum to be resected. This study aimed to evaluate food tolerance after preservation or resection of the antrum during LSG.MethodsProspective randomized study included 50 patients scheduled for LSG. Participants were randomly allocated into one of two groups. In antral resection (AR-LSG) group (n = 25), resection started 2 cm from the pylorus. In antral sparing (AS-LSG) group (n = 25), it started 6 cm from the pylorus. Percentage of excess weight loss (%EWL) and percentage of excess BMI loss (%EBL) were evaluated after 3 and 6 months. Quality of life (QOL) was evaluated by using the Bariatric Analysis and Reporting Outcome System (BAROS). Food tolerance was assessed using the Quality of Alimentation questionnaire. Primary outcome measure was food tolerance and %EWL.ResultsFood tolerance was significantly better in the antral sparing group compared to the antral resection group after 3 and 6 months. The two groups were comparable in %EWL and BMI change after 3 and 6 months. Six months after surgery, the majority of patients had a very good quality of life, with no significant difference between the two groups (p = 0.877). There was no significant difference between the two groups in operative time, intraoperative blood loss, and hospital stay.ConclusionsPreservation of the pyloric antrum during LSG is associated with significantly better food tolerance and comparable effect of weight loss up to 6 months postoperatively when compared with total antral resection.