Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.

IMPORTANCE: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976.

Evaluation of the Swedish adjustable gastric band VC (SAGB-VC) in an Australian population: early results.

BACKGROUND: The Swedish adjustable gastric band VC (SAGB-VC) has been in use in Australia since 2007. We evaluated its efficacy and safety. METHODS: We retrospectively analyzed the prospective clinical data of patients who received the implant between November 2007 and June 2009 at 3 Australian bariatric centres. RESULTS: In all, 1176 patients (mean age 45.9 [standard deviation (SD) 12.3] yr, mean body mass index 43.4 [SD 7.6]) received the SAGB-VC. At a mean follow-up of 11 (SD 3) months, weight reduced by a mean of 18.4 (SD 11.1) kg with an excess weight loss of 37.8% (SD 19.9%). Body mass index decreased (from mean 43.4 [SD 7.7] to mean 36.7 [SD 6.5], p < 0.001). Type 2 diabetes (T2DM) was reported in 167 patients and hypertension in 373. Improvement occurred in 73.5% of patients with T2DM and 31% with hypertension, with patient-reported reduction or cessation of medication. Metabolic syndrome indices improved during follow-up: high-density lipoprotein cholesterol (mean 1.3 [SD 0.3] v. mean 1.4 [SD 0.3] mmol/L, p < 0.001), triglycerides (mean 1.6 [SD 0.8] v. mean 1.3 [SD 0.7] mmol/L, p < 0.001), waist circumference (men 141 [SD 103] to 121 [SD 15] cm, women 117 [SD 14] to 105 [SD 14] cm, both p < 0.001), C-reactive protein (90.5 [SD 75.2] v. 53.3 [SD 61.9] nmol/L, p < 0.001). The complication rate was 4.2%. CONCLUSION: The SAGB-VC is safe and effective for treating obesity and its comorbidities. The results are reproducible in separate Australian centres and consistent with published literature.

Improvement in comorbid illness after placement of the Swedish Adjustable Gastric Band.

BACKGROUND: Obesity and its related comorbid illnesses have become a national health priority. We report comorbidity and quality of life (QoL) data after weight loss with gastric banding using the Swedish Adjustable Gastric Band (SAGB). METHODS: Data were collected prospectively for 838 consecutive morbidly obese patients who underwent laparoscopic adjustable gastric banding (LAGB) between January 2001 and July 2007. Patients were followed-up by a multidisciplinary team consisting of a surgeon, physician, dietician, and exercise consultant, all of whom were involved in the evaluation of clinical outcomes. Continuous data were reported as mean +/- SD; categorical data were reported as number and percentage. Patients served as their own controls. RESULTS: Respective preoperative mean age, weight, and body mass index (BMI) were 44 years (range 16-76), 122 kg (range 86-240), and 44 kg/m2 (range 35-86), respectively. SAGB implantation was accomplished by the pars flaccida technique with no conversion to an open procedure. Mature follow-up data were available for 35% of patients at 24 months and 21% at 36 months. In the total cohort of 838 patients, BMI (mean +/- SD) decreased to 32 +/- 5 kg/m2 and 32 +/- 7 kg/m2 at 24 months and 36 months, respectively. Percentage excess weight loss (%EWL) (mean +/- SD) was 32% +/- 14% (n = 506), 47% +/- 15% (n = 461), 52% +/- 16% (n = 291), and 54% +/- 23% (n = 175) at 6, 12, 24, and 36 months, respectively (P < .001). There were 545 patients identified with comorbid illness at >6-month follow-up. After a median follow-up of 13 months (range 6-36 months), resolution and/or improvement of comorbidities was as follows: type 2 diabetes mellitus, 79%; metabolic syndrome, 78%; hypertension, 67%; dyslipidemia, 66%; gastroesophageal reflux, 66%; asthma, 57%; arthritis/joint pain, 70%; polycystic ovarian syndrome, 48%; and depression, 57%. There was a significant improvement in QoL (as measured by the Short Form-36 Health Survey [SF-36]), bringing patients' QoL to a level consistent with that of community norms in all 8 domain scores. Of 342 patients surveyed with the Beck Depression Inventory (BDI-II), a statistically significant improvement in depressive mood was also observed (P < .001). CONCLUSION: Weight loss achieved by use of the SAGB provides a dramatic reduction in many serious comorbid illnesses as well as improvement in the psychosocial wellbeing of morbidly obese patients.

Gastric banding for the treatment of type 2 diabetes mellitus in morbidly obese.

BACKGROUND: To assess the efficacy of the Swedish adjustable gastric band in the treatment of type 2 diabetes mellitus (T2DM), impaired glucose tolerance (IGT), and the metabolic syndrome (MS) in the morbidly obese. METHODS: We identified all patients with T2DM, IGT, or the MS at surgery from our database of 905 consecutive patients who had undergone placement of the Swedish adjustable gastric band between January 2001 and April 2007. The patients were followed up by our multidisciplinary team, and their T2DM was managed by their treating primary care physician and/or endocrinologist. RESULTS: A total of 682 patients had >6 months of follow-up. Of these, 78 patients had T2DM, 64 had IGT, and 100 had the MS. At a median follow-up of 12.5 months, patients with T2DM had a mean +/- SD excess weight loss of 38% +/- 15%. This was associated with hemoglobin A1c and fasting blood sugar levels decreasing from 8.0% +/- 1.7% to 6.1% +/- 1.0% (P <.0001) and from 9.6 +/- 3.4 mmol/L to 5.7 +/- 1.5 mmol/L (P <.0001), respectively. Remission and/or improvement in patients with T2DM was judged by the complete cessation and/or reduction in medication and normalization of laboratory values. This occurred in 81% of those taking oral hypoglycemic agents. Of the patients taking a combination of oral hypoglycemic agents and insulin, 43% ceased and/or reduced their oral hypoglycemic agents, and 93% ceased and/or reduced their insulin requirements. Of those on insulin only, 75% ceased and/or reduced their insulin. No patient with IGT developed diabetes or progressed to require medications. Remission and/or improvement in the MS occurred in 88% of patients. Remission of T2DM was dependent on both the magnitude of excess weight loss (P = .008) and the duration of the pre-existing T2DM. Using binary logistic regression analysis, a duration of T2DM of <5 years before surgery was 6.5 times more likely to lead to resolution of T2DM after the weight loss (P = .004). CONCLUSION: Weight loss after Swedish adjustable gastric band placement is an effective treatment of T2DM in morbidly obese patients, with early intervention offering the greatest chance of remission. It might even prevent the occurrence of T2DM in patients with IGT.

Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the VBLOC DM2 Study.

BACKGROUND: One-year results of the VBLOC DM2 study found that intermittent vagal blocking (VBLOC therapy) was safe among subjects with obesity and type 2 diabetes mellitus (T2DM) and led to significant weight loss and improvements in glycemic parameters and cardiovascular risk factors. Longer-term data are needed to determine whether the results are sustained. METHODS: VBLOC DM2 is a prospective, observational study of 28 subjects with T2DM and body mass index (BMI) between 30 and 40 kg/m(2) to assess mid-term safety and weight loss and improvements in glycemic parameters, and other cardiovascular risk factors with VBLOC therapy. Continuous outcome variables are reported using mixed models. RESULTS: At 24 months, the mean percentage of excess weight loss was 22% (95% CI, 15 to 28, p < 0.0001) or 7.0% total body weight loss (95% CI, 5.0 to 9.0, p < 0.0001). Hemoglobin A1c decreased by 0.6 percentage points (95% CI, 0.2 to 1.0, p = 0.0026) on average from 7.8% at baseline. Fasting plasma glucose declined by 15 mg/dL (95% CI, 0 to 29, p = 0.0564) on average from 151 mg/dL at baseline. Among subjects who were hypertensive at baseline, systolic blood pressure declined 10 mmHg (95% CI, 2 to 19, p = 0.02), diastolic blood pressure declined by 6 mmHg (95% CI, 0 to 12, p = 0.0423), and mean arterial pressure declined 7 mmHg (95% CI, 2 to 13, p = 0.014). Waist circumference was significantly reduced by 7 cm (95% CI, 4 to 10, p < 0.0001) from a baseline of 120 cm. The most common adverse events were mild or moderate heartburn, implant site pain, and constipation. CONCLUSIONS: Improvements in obesity and glycemic control were largely sustained after 2 years of treatment with VBLOC therapy with a well-tolerated risk profile.

The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity.

BACKGROUND: Intermittent, reversible intraabdominal vagal blockade (VBLOC® Therapy) demonstrated clinically important weight loss in feasibility trials. EMPOWER, a randomized, double-blind, prospective, controlled trial was conducted in USA and Australia. METHODS: Five hundred three subjects were enrolled at 15 centers. After informed consent, 294 subjects were implanted with the vagal blocking system and randomized to the treated (n = 192) or control (n = 102) group. Main outcome measures were percent excess weight loss (percent EWL) at 12 months and serious adverse events. Subjects controlled duration of therapy using an external power source; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Devices in both groups performed regular, low-energy safety checks. Data are mean ± SEM. RESULTS: Study subjects consisted of 90 % females, body mass index of 41 ± 1 kg/m(2), and age of 46 ± 1 years. Device-related complications occurred in 3 % of subjects. There was no mortality. 12-month percent EWL was 17 ± 2 % for the treated and 16 ± 2 % for the control group. Weight loss was related linearly to hours of device use; treated and controls with ≥ 12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL, respectively. CONCLUSIONS: VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.