Long-term impact of weight loss for people with overweight but not obesity, and with type 2 diabetes: 10-year outcomes of a randomized trial of gastric band surgery.

AIM: Randomized trials reporting 5-year outcomes have shown bariatric surgery  to induce diabetes remission and improve cardiovascular risk. However, the longer-term effects of surgery are uncertain, with only one randomized trial reporting 10-year diabetes outcomes in people with obesity. We aimed to compare 10-year diabetes outcomes of people who are overweight but not obese, randomly assigned to receive either multidisciplinary diabetes care, or multidisciplinary diabetes care combined with gastric band (GB) surgery. METHODS: Between 2009 and 2011, 51 adults were randomized. After 5 years, they were discharged to receive community care and reassessed after 10 years. The primary outcome was diabetes remission, defined as glycated haemoglobin (HbA1c) <6.5% (48 mmol/mol) without glucose-lowering medication. RESULTS: Forty-one participants (20 medical and 21 GB) completed the 10-year assessment. The median (Q1, Q3) weight loss in the GB group was 9.8 (6.7, 16.3)% at 10 years compared with 5.6 (3.4, 7.6)% in the medical group (median difference 4.2%; p = .008). Diabetes remission occurred in five GB participants and no medical participants (relative risk 0.76, 95% CI: 0.55-0.93, p = .048). GB participants used fewer glucose-lowering medications at 10 years but HbA1c, fasting glucose, calculated cardiovascular risk, quality-of-life and incident diabetes complications did not differ significantly between the groups. CONCLUSION: When compared with medical care, GB surgery achieved greater weight loss and modestly increased the likelihood of diabetes remission. However, it did not improve HbA1c, cardiovascular risk or quality of life.

Pre-operative Restraint and Post-operative Hunger, Disinhibition and Emotional Eating Predict Weight Loss at 2 Years Post-laparoscopic Adjustable Gastric Banding.

INTRODUCTION: A principal mechanism of action in bariatric surgery is reduction in calorie consumption due to decreased hunger and increased satiety. Patients' ability to perceive post-operative changes to their hunger is therefore central to optimal results. This study examined factors that may impact how patients perceive post-operative hunger and how perception of hunger impacts eating and subsequent weight loss after laparoscopic adjustable gastric banding (LAGB). METHODS: Patients undertaking LAGB (n = 147) provided pre-surgery and 2-year weight loss data and pre-surgery and 12-month psychological data (perception of hunger, disinhibition related to eating, emotional eating). RESULTS: Path analysis demonstrated that patients with lower levels of pre-surgery cognitive restraint over eating experienced significantly greater reduction in perception of hunger at 12 months post-surgery. Perceived reduction in hunger was significantly associated with lower levels of both emotional eating and disinhibited eating. Finally, reduced emotional eating at 12 months significantly predicted 9% of the variance in percentage of total weight loss (%TWL) at 2 years after surgery. CONCLUSION: These initial findings suggest that preparation for bariatric surgery may be enhanced by psychoeducation regarding cognitive restraint over eating and its effect on hunger perception. In addition, psychological treatment that focuses on identifying and responding to changes in hunger may contribute to improved outcomes for those who have difficulty adjusting to post-operative eating behaviours.

Identification of Metabolically Distinct Adipocyte Progenitor Cells in Human Adipose Tissues.

Adipocyte progenitor cells (APCs) provide the reservoir of regenerative cells to produce new adipocytes, although their identity in humans remains elusive. Using FACS analysis, gene expression profiling, and metabolic and proteomic analyses, we identified three APC subtypes in human white adipose tissues. The APC subtypes are molecularly distinct but possess similar proliferative and adipogenic capacities. Adipocytes derived from APCs with high CD34 expression exhibit exceedingly high rates of lipid flux compared with APCs with low or no CD34 expression, while adipocytes produced from CD34- APCs display beige-like adipocyte properties and a unique endocrine profile. APCs were more abundant in gluteofemoral compared with abdominal subcutaneous and omental adipose tissues, and the distribution of APC subtypes varies between depots and in patients with type 2 diabetes. These findings provide a mechanistic explanation for the heterogeneity of human white adipose tissue and a potential basis for dysregulated adipocyte function in type 2 diabetes.

Inhibition of mTOR Signaling and Clinical Activity of Rapamycin in Head and Neck Cancer in a Window of Opportunity Trial.

PURPOSE: We studied the impact of mTOR signaling inhibition with rapamycin in head and neck squamous cell carcinoma (HNSCC) in the neoadjuvant setting. The goals were to evaluate the mTOR pathway as a therapeutic target for patients with advanced HNSCC, and the clinical safety, antitumor, and molecular activity of rapamycin administration on HNSCC. PATIENTS AND METHODS: Patients with untreated stage II-IVA HNSCC received rapamycin for 21 days (day 1, 15 mg; days 2-12, 5 mg) prior to definitive treatment with surgery or chemoradiation. Treatment responses were assessed clinically and radiographically with CT and FDG-PET. Pre- and posttreatment biopsies and blood were obtained for toxicity, immune monitoring, and IHC assessment of mTOR signaling, as well as exome sequencing. RESULTS: Sixteen patients (eight oral cavity, eight oropharyngeal) completed rapamycin and definitive treatment. Half of patients were p16 positive. One patient had a pathologic complete response and four (25%) patients met RECIST criteria for response (1 CR, 3 PR, 12 SD). Treatment was well tolerated with no grade 4 or unexpected toxicities. No significant immune suppression was observed. Downstream mTOR signaling was downregulated in tumor tissues as measured by phosphorylation of S6 (P < 0.0001), AKT (P < 0.0001), and 4EBP (P = 0.0361), with a significant compensatory increase in phosphorylated ERK in most patients (P < 0.001). Ki67 was reduced in tumor biopsies in all patients (P = 0.013). CONCLUSIONS: Rapamycin treatment was well tolerated, reduced mTOR signaling and tumor growth, and resulted in significant clinical responses despite the brief treatment duration, thus supporting the potential role of mTOR inhibitors in treatment regimens for HNSCC.

Long-Term Outcomes After Bariatric Surgery: a Systematic Review and Meta-analysis of Weight Loss at 10 or More Years for All Bariatric Procedures and a Single-Centre Review of 20-Year Outcomes After Adjustable Gastric Banding.

INTRODUCTION: Durability is a key requirement for the broad acceptance of bariatric surgery. We report on durability at and beyond 10 years with a systematic review and meta-analysis of all reports providing data at 10 or more years and a single-centre study of laparoscopic adjustable gastric banding (LAGB) with 20 years of follow-up. METHODS: Systematic review with meta-analysis was performed on all eligble reports containing 10 or more years of follow-up data on weight loss after bariatric surgery. In addition, a prospective cohort study of LAGB patients measuring weight loss and reoperation at up to 20 years is presented. RESULTS: Systematic review identified 57 datasets of which 33 were eligible for meta-analysis. Weighted means of the percentage of excess weight loss (%EWL) were calculated for all papers included in the systematic review. Eighteen reports of gastric bypass showed a weighted mean of 56.7%EWL, 17 reports of LAGB showed 45.9%EWL, 9 reports of biliopancreatic bypass +/- duodenal switch showed 74.1%EWL and 2 reports of sleeve gastrectomy showed 58.3%EWL. Meta-analyses of eligible studies demonstrated comparable results. Reoperations were common in all groups. At a single centre, 8378 LAGB patients were followed for up to 20 years with an overall follow-up rate of 54%. No surgical deaths occurred. Weight loss at 20 years (N = 35) was 30.1 kg, 48.9%EWL and 22.2% total weight loss (%TWL). Reoperation rate was initially high but reduced markedly with improved band and surgical and aftercare techniques. CONCLUSION: All current procedures are associated with substantial and durable weight loss. More long-term data are needed for one-anastomosis gastric bypass and sleeve gastrectomy. Reoperation is likely to remain common across all procedures.

Diabetes Outcomes More than a Decade Following Sustained Weight Loss After Laparoscopic Adjustable Gastric Band Surgery.

BACKGROUND: Long-term outcome data are needed to define the role of bariatric surgery in type 2 diabetes (T2D). To address this, we collated diabetes outcomes more than a decade after laparoscopic adjustable gastric band (LAGB) surgery. METHOD: Clinical and biochemical measures from 113 obese T2D patients who underwent LAGB surgery in 2003 and 2004 were analyzed. Diabetes remission was defined as HbA1c < 6.2% (44 mmol/mol) and fasting glucose < 7.0 mmol/L. RESULTS: Seventy-nine patients had weight data at 10 years and attained a median [Q1, Q3] weight loss of 16 [10, 21] percent. Sixty patients attended a follow-up assessment. Their baseline HbA1c of 7.8 [7.1, 9.3] percentage units (62 [54, 78] mmol/mol) had decreased to 6.6 [6.1, 8.4] (49 [43, 68] mmol/mol) despite no significant change in glucose-lowering therapy. Eleven patients (18%) were in diabetes remission and another 18 had HbA1c ≤ 6.5%. Significant improvements in physical measures of quality of life, blood pressure, and lipid profile were also observed but there was no change in the proportion of patients with albuminuria and a significant decline in estimated glomerular filtration rate. Twelve patients in the follow-up cohort (20%) required anti-reflux medication after surgery and 26 (43%) underwent gastric band revision surgery. CONCLUSION: Weight loss for over 10 years after LAGB surgery delivers clinically meaningful improvements in HbA1c, blood pressure, lipids, and quality of life at the cost of a high rate of revision surgery and increased use of anti-reflux medication. These findings support the use of bariatric surgery as a long-term treatment for weight loss and wellbeing in patients with T2D. STUDY REGISTRATION: Registered with the Australian Clinical trials registry as ACTRN12615000089538.

Detailed Description of Change in Serum Cholesterol Profile with Incremental Weight Loss After Restrictive Bariatric Surgery.

INTRODUCTION: Dyslipidemia affects up to 75% of morbidly obese individuals and is a key driver of cardiovascular disease. Weight loss is an established strategy to improve metabolic risk, including dyslipidemia. We aimed to determine weight loss goals for resolution of serum lipid abnormalities, by measuring improvements during progressive weight loss in obese individuals. METHODS: We performed a prospective cohort study of obese individuals with the metabolic syndrome undergoing adjustable gastric banding. Lipid levels were monitored monthly for 9 months, then three monthly until 24 months. RESULTS: There were 101 participants included, age 47.4 ± 10.9 years with body mass index 42.6 ± 5.9 kg/m2. At 24 months, total body weight loss (TBWL) was 18.3 ± 7.9%. This was associated with significant improvements in high-density lipoprotein (HDL) (1.18 vs 1.47, p < 0.001), triglyceride (2.0 vs 1.4, p < 0.001), and total cholesterol to HDL ratio (TC:HDL) (4.6 vs 3.6, p < 0.001). Over this time, progressive and linear improvements in HDL, triglycerides, and TC:HDL were seen with incremental weight loss (observed at 2.5% TBWL intervals). Significant improvements occurred after a threshold weight loss of 7.5-12.5% TBWL was achieved, with odds ratio (OR) 1.48-2.50 for normalization. These odds improved significantly with increasing weight loss (OR 18.2-30.4 with > 25% TBWL). Despite significant weight loss, there was no significant change in low-density lipoprotein (LDL). CONCLUSION: Significant improvements in triglycerides, HDL, and TC:HDL occur after 7.5-12.5% TBWL, with ongoing benefit after greater weight loss. LDL needs to be addressed independently, as this was not observed to respond to weight loss alone. TRIAL REGISTRATION NUMBER: Australian Clinical Trials Registry (ACTRN12610000049077).

Cost-effectiveness of gastric band surgery for overweight but not obese adults with type 2 diabetes in the U.S.

AIM: To determine the cost-effectiveness of gastric band surgery in overweight but not obese people who receive standard diabetes care. METHOD: A microsimulation model (United Kingdom Prospective Diabetes Study outcomes model) was used to project diabetes outcomes and costs from a two-year Australian randomized trial of gastric band (GB) surgery in overweight but not obese people (BMI 25 to 30kg/m2) on to a comparable population of U.S. adults from the National Health and Nutrition Examination Survey (N=254). Estimates of cost-effectiveness were calculated based on the incremental cost-effectiveness ratios (ICERs) for different treatment scenarios. Costs were inflated to 2015 U.S. dollar values and an ICER of less than $50,000 per QALY gained was considered cost-effective. RESULTS: The incremental cost-effectiveness ratio for GB surgery at two years exceeded $90,000 per quality-adjusted life year gained but decreased to $52,000, $29,000 and $22,000 when the health benefits of surgery were assumed to endure for 5, 10 and 15 years respectively. The cost-effectiveness of GB surgery was sensitive to utility gained from weight loss and, to a lesser degree, the costs of GB surgery. However, the cost-effectiveness of GB surgery was affected minimally by improvements in HbA1c, systolic blood pressure and cholesterol. CONCLUSIONS: GB surgery for overweight but not obese people with T2D appears to be cost-effective in the U.S. setting if weight loss endures for more than five years. Health utility gained from weight loss is a critical input to cost-effectiveness estimates and therefore should be routinely measured in populations undergoing bariatric surgery.

The Physiology and Pathophysiology of Gastroesophageal Reflux in Patients with Laparoscopic Adjustable Gastric Band.

INTRODUCTION: The effect of the laparoscopic adjustable gastric band (LAGB) on esophageal acid exposure and reflux is poorly understood. Optimal technique and normative values for acid exposure have not been established in this group. METHODS: High-resolution manometry (HRM) and 24-h ambulatory esophageal pH monitoring were performed in three groups: asymptomatic LAGB, symptomatic LAGB, and pre-operative reflux patients. This technique utilized intraluminal pressure signatures during HRM to guide accurate pH sensor placement. RESULTS: The LAGB groups were well matched: age 48 vs 51 years (p = 0.249), weight loss 27.3 vs 26.7 kg (p = 0.911). The symptomatic group had a larger gastric pouch (5.2 vs 3.3 cm, p = 0.012), with higher esophageal acid exposure (10.8 vs 0.9%, p < 0.001). Two acidification patterns were observed: irritant and volume acidification, associated with substantial supine acidification. Symptomatic LAGB had altered esophageal motility, with poorer lower esophageal sphincter basal tone (8.0 vs 17.7 mmHg, p = 0.022) and impaired contractility of the lower esophageal segment (90 vs 40%, p = 0.009). Compared to pre-operative reflux patients, symptomatic LAGB patients demonstrated higher total and supine esophageal acid exposure (10.8 vs 7.0%, p = 0.010; 14.9 vs 5.1%, p < 0.001), less symptoms (2 vs 6, p = 0.001) and lower symptom index (0.7 vs 0.9, p = 0.010). CONCLUSIONS: Ambulatory pH monitoring is an effective technique if the pH sensor is positioned appropriately using HRM. The correctly positioned LAGB appears associated with low esophageal acidification. In contrast, patients with symptoms or pouch dilatation can have markedly elevated esophageal acidification, particularly when supine. This is a different pattern compared to pre-operative patients and importantly can be disproportionate to symptoms.

The Band Must Not Be Abandoned.

The use of laparoscopic adjustable gastric banding (LAGB) is on the decline around the world despite the evidence base suggesting that it is a safe, effective and durable short-stay procedure which can be safely revised and is well tolerated by patients when they are appropriately supported. Currently, less than 1% of eligible obese persons are choosing to undergo bariatric surgery. If we are to improve uptake of bariatric surgery we need a raft of therapeutic options, including the LAGB, which sit between the relative impotence of medical therapies and the aggression of stapling procedures. This brief communication discusses what some of the drivers may be that are leading surgeons to abandon the band.

Modified thresholds for fibrosis risk scores in nonalcoholic fatty liver disease are necessary in the obese.

BACKGROUND: Obesity and its related comorbidities are significant risk factors for nonalcoholic fatty liver disease (NAFLD). Liver fibrosis is the major determinant of long-term outcomes in NAFLD. A non-invasive tool that accurately identifies obese patients at elevated risk of liver fibrosis would be of significant value. Fibrosis risk scores in patients with NAFLD have been proposed but have not been validated in obese populations. We aimed to validate established simple fibrosis scores in bariatric surgical patients. METHODS: We conducted a prospective study of 107 consecutive high-risk obese patients undergoing primary bariatric surgery. Proposed fibrosis scores (NAFLD fibrosis score; body mass index (BMI), aspartate aminotransferase (AST)/alanine aminotransferase ratio (ALT), and diabetes (BARD); Fibrosis-4 (FIB-4); Forn; and AST to platelet ratio index) were calculated and compared hepatic fibrosis determined by histology of intraoperative liver biopsies. Accuracy was determined, and fibrosis score thresholds were optimized. These modified thresholds were then validated in an independent bariatric surgical population. RESULTS: Liver biopsies were available in 101 patients. Sixty-eight patients had some degree of fibrosis, with 23 patients (23 %) having significant fibrosis (F2-4). The Forn score best predicted significant fibrosis (area under the receiver operator characteristic curve (AUROC) 0.724, p = 0.001). With standard thresholds, the sensitivity for the Forn score for identification of significant fibrosis (F2-4) was 0 %. Using modified thresholds of 3.5, the sensitivity and negative predictive value increased to 85.7 and 94.7 %. This threshold was applied to an independent validation cohort with good accuracy. CONCLUSIONS: Fibrosis risk scores using simple markers have moderate success at delineating obese patients with significant NAFLD-related fibrosis. Thresholds, however, need to be lowered to maximize diagnostic accuracy in this cohort.

Effects of Bariatric Surgery on Liver Function Tests in Patients with Nonalcoholic Fatty Liver Disease.

OBJECTIVES: Nonalcoholic fatty liver disease (NAFLD) affects over 80% of obese patients and is fueled by the metabolic syndrome. Weight loss is strongly advocated as a central treatment for NAFLD and has been shown to induce histological improvement. We aimed to define the patterns of improvement in NAFLD with weight loss and determine target weight goals for NAFLD resolution. METHODS: A prospective study of 84 morbidly obese patients with NAFLD undergoing bariatric surgery was conducted. Intraoperative liver biopsies were taken. Monthly follow-up, including blood tests and measurements, was performed. We monitored improvements in NAFLD by monthly alanine aminotransferase (ALT) and gamma glutamyltransferase (GGT) levels over 1 year. RESULTS: There was rapid improvement in ALT, particularly in the first 6 months following surgery, with statistically significant reduction in ALT at 2 months (35 vs 27 IU/L, p < 0.001). In multivariate analysis, there were significantly increased odds of ALT normalization after a %TBWL of 10-15% (odds ratio 2.49, p = 0.005). The odds of resolution increased with increasing weight loss. Triglyceride levels (odds ratio 0.59, p = 0.021) and baseline NAFLD activity score (odds ratio 0.28, p < 0.001) were also significantly related to ALT normalization. Improvements in ALT occurred prior to metabolic improvement and well before traditional ideal weight goals were reached. CONCLUSION: Improvements in NAFLD occurred rapidly after bariatric surgery and were closely related to weight loss and metabolic factors. A 10-15% reduction in body weight is an appropriate target to achieve substantial improvement in ALT levels. TRIAL REGISTRATION NUMBER: Australian Clinical Trials Registry (ACTRN12610000049077).

Changes in Outcomes, Satiety and Adverse Upper Gastrointestinal Symptoms Following Laparoscopic Adjustable Gastric Banding.

BACKGROUND: Patient-reported outcomes and perceptions are critical to the overall efficacy and acceptability of a surgical procedure. Outcomes, such as patient satisfaction and perceived success of the surgery and adverse symptoms, have not been described in detail following bariatric surgery. The associations and predictors of patient satisfaction have not been defined. This study aimed to examine long-term outcomes and perceptions after laparoscopic adjustable gastric banding (LAGB). METHODS: We conducted a prospective study of outcomes, satiety and adverse upper gastrointestinal symptoms, as well as quality of life and subjective patient satisfaction in LAGB patients. Data were collected at 3 years (T1) and 8 years post-operatively (T2). RESULTS: One-hundred and sixty patients completed follow-up at T1 and T2. The average age was 44.0 ± 11.2 years. At T2, the total body weight loss was 17.8 ± 11.9 %. Satisfaction decreased significantly between time points (8.6 ± 1.8 vs 7.2 ± 2.9, p < 0.01), and quality of life reduced slightly across all domains. Hunger scores remained low (3.8 ± 1.8 vs 3.9 ± 1.8, p = 0.61). The dysphagia score did not change significantly (p = 0.54). There was minimal change in frequency of regurgitation, although there was significant increase in patient assessment of how bothered they were by regurgitation. Multivariate analysis identified increased awareness of regurgitation as a principal driver of reduced satisfaction. CONCLUSIONS: Weight loss, satiety and adverse symptoms demonstrated only slight changes between 3 and 8 years post-operatively. Despite this, overall satisfaction and perception of success of the procedure reduced markedly. This appeared mediated by reduced tolerance of adverse symptoms. These data inform follow-up practises aimed at optimizing outcomes.

Diagnosis and Management of Oesophageal Cancer in Bariatric Surgical Patients.

BACKGROUND: Oesophageal cancer following bariatric surgery adds significant complexity to an already challenging disease. There is limited data on the diagnosis, presentation and management in these complex cases. METHODS: A retrospective cohort study on prospectively collected data over 10 years was conducted. The oesophago-gastric cancer database was searched for patients with prior bariatric surgery. Data were retrieved on bariatric and cancer management. RESULTS: We identified nine patients with oesophageal or gastro-oesophageal junction adenocarcinoma after bariatric surgery. Mean age was 58.3 ± 6.9 years, and duration from bariatric surgery was 13.2 ± 9.4 years. Weight loss at diagnosis was 30.6 ± 23.3 kg (excess weight loss 58.1 % ± 29.6). Modes of presentation were Barrett's surveillance (n = 3), reflux symptoms (n = 4) and incidental (n = 2). Management was surgical resection (n = 4), endoscopic mucosal resection (n = 2) and palliative (n = 3). Surgical resections were challenging due to adhesions, obesity, luminal dilatation and scarring on the stomach. There were two substantial leaks following gastroplasty. CONCLUSIONS: Oesophageal cancer following bariatric surgery is a challenging problem, and surgical resection carries high risk. A high index of suspicion is required and symptoms investigated precipitously. Technical challenges of operating on obese patients and the specific effects of previous bariatric procedures need to be understood, particularly the limitations on reconstructive options.

Development of a Measure of Barriers to Laparoscopic Adjustable Gastric Banding (LAGB) Aftercare Attendance.

BACKGROUND: Regular aftercare attendance following laparoscopic adjustable gastric banding (LAGB) is associated with greater weight loss and fewer post-surgical complications. Despite high reported rates of attrition from LAGB aftercare, the reasons for non-attendance have not been thoroughly explored. The aim of the current study was to describe the scale development, explore the factor structure and evaluate the psychometric properties of the Gastric Banding Aftercare Attendance Questionnaire (GBAAQ)-a tool that measures barriers to aftercare attendance in LAGB patients. METHODS: One hundred and eighty-three participants completed the GBAAQ; 107 regular attendees and 76 non-attendees. RESULTS: A factor analysis identified four factors (Treatment Approach, Time Constraints, Stress and Pressures, Uncomfortable Participating) that demonstrated good known-groups validity and internal consistency. CONCLUSIONS: Although further validation is needed, the results of the present study provide preliminary support for the validity of the GBAAQ. Knowledge about the barriers to LAGB aftercare attendance can be used to identify those most at risk of non-attendance and can inform strategies aimed at reducing non-attendance.

The Effect of Weight Loss on Indigenous Australians with Diabetes: a study of Feasibility, Acceptability and Effectiveness of Laparoscopic Adjustable Gastric Banding.

BACKGROUND/OBJECTIVES: Diabetes and obesity are common and serious health challenges for indigenous people worldwide. The feasibility of achieving substantial weight loss, leading to remission of diabetes, was evaluated in a regional indigenous Australian community. SUBJECTS/METHODS: A prospective cohort study of 30 obese indigenous adults from the Rumbalara Aboriginal Co-operative in Central Victoria was performed. Inclusion criteria included aboriginality, BMI > 30 kg/m(2) and diabetes diagnosed within the last 10 years. Weight loss was achieved using laparoscopic adjustable gastric banding (LAGB). Participants were treated in their community and followed for 2 years. Outcomes were compared with those of non-indigenous Australians from an earlier randomized controlled trial (RCT) using a similar protocol. RESULTS: 30 participants (26 females, mean age 44.6 years; mean BMI 44.3) had LAGB at the regional hospital. Twenty-six participants completed diabetes assessment at 2 years follow-up. They showed diabetes remission (fasting blood glucose < 7.0 mmol/L and haemoglobin A1c (HbA1c) < 6.2 % while off all therapy except metformin) in 20 of the 26 and a mean weight loss (SD) of 26.0 (14) kilograms. Based on intention-to-treat, remission rate was 66 %. Quality of life improved. There was one early event and 12 late adverse events. The outcomes for weight loss and diabetes remission were not different from the LAGB group of the RCT. CONCLUSIONS: For obese indigenous people with diabetes, a regionalized model of care centred on the LAGB is an effective approach to a serious health problem. The model proved feasible and acceptable to the indigenous people. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN 12609000319279).

Concurrent Large Para-oesophageal Hiatal Hernia Repair and Laparoscopic Adjustable Gastric Banding: Results from 5-year Follow Up.

OBJECTIVE: The objective of the study is to identify the efficacy and safety of combining laparoscopic adjustable gastric banding with repair of large para-oesophageal hernias. BACKGROUND: Para-oesophageal hernias are more common in the obese with higher recurrence rates following repair. The effect and safety of combining para-oesophageal hernia repair with laparoscopic adjustable gastric banding is unknown. METHODS: One-hundred fourteen consecutive patients undergoing primary laparoscopic adjustable gastric banding with concurrent repair of a large para-oesophageal hernia were prospectively identified and matched to a control group undergoing primary laparoscopic adjustable gastric banding only. Weight loss and complication data were retrieved from a prospectively maintained database, and a standardised bariatric outcome questionnaire was used to assess post-operative symptoms, satisfaction with surgery and satiety scores. RESULTS: At a mean follow up of 4.9 ± 2.1 years, total weight loss was 16.4 ± 9.9% in the hernia repair group and 17.6 ± 12.6% in the control group (p = 0.949), with 17 vs. 11% loss to follow up rates (p = 0.246). No statistically significant difference in revisional surgery rate and symptomatic recurrence of hiatal hernia was documented in four patients in the hernia repair group (3.5%). No statistically significant difference in mean reflux (9.9 vs. 10.3, p = 0.821), dysphagia (20.7 vs. 20.1, p = 0.630) or satiety scores was identified. CONCLUSIONS: Concurrent repair of large para-oesophageal hiatal hernia and laparoscopic adjustable gastric banding placement is safe and effective both in terms of symptom control and weight loss over the intermediate term. In obese patients with large hiatal hernias, consideration should be given to combining repair of the hernia with a bariatric procedure.

Gastric Band Surgery Leads to Improved Insulin Secretion in Overweight People with Type 2 Diabetes.

BACKGROUND: We aimed to determine the effects of laparoscopic adjustable gastric band (LAGB) on beta-cell function in overweight people with type 2 diabetes and to assess the relationship between baseline beta-cell function and glycemic outcomes. METHODS: We studied 44 overweight but not obese people with type 2 diabetes who participated in a randomized trial whose primary outcome was the rate of diabetes remission after 2 years of multidisciplinary diabetes care (MDC group) or multidisciplinary care combined with LAGB. Dynamic beta-cell function was assessed by intravenous glucose challenge, and basal beta-cell function (HOMA-B) and insulin sensitivity (HOMA-S) were determined using the homeostatic model. RESULTS: Twelve LAGB participants and two MDC participants were in diabetes remission at 2 years. HOMA-S and the C-peptide response to intravenous glucose increased significantly in LAGB but not in MDC participants. The insulin response to glucose did not change in LAGB participants, whereas their fasting C-peptide/insulin ratio increased. Baseline measures of beta-cell function correlated with diabetes remission but not with reduction in HbA1c following LAGB. CONCLUSIONS: In overweight people with diabetes, LAGB improves endogenous beta-cell function after 2 years. Baseline beta-cell function correlated with diabetes remission, but not with HbA1c change following LAGB.