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Scottsdale, AZ, United States

Ikramuddin S.,University of Minnesota | Korner J.,Columbia University | Lee W.-J.,National Taiwan University Hospital | Connett J.E.,University of Minnesota | And 15 more authors.
JAMA - Journal of the American Medical Association | Year: 2013

Importance: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. Objective: To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. Design, Setting, and Participants: A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. Interventions: Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. Main Outcomes and Measures: Composite goal of HbA 1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. Results: All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. Conclusions and Relevance: In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. Trial Registration: clinicaltrials.gov Identifier: NCT00641251. ©2013 American Medical Association. All rights reserved.

Sathananthan M.,Rochester College | Ikramuddin S.,University of Minnesota | Swain J.M.,Rochester College | Swain J.M.,Scottsdale Healthcare Bariatric Center | And 7 more authors.
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy | Year: 2014

Purpose: Vagal interruption causes weight loss in humans and decreases endogenous glucose production in animals. However, it is unknown if this is due to a direct effect on glucose metabolism. We sought to determine if vagal blockade using electrical impulses alters glucose metabolism in humans. Patients and methods: We utilized a randomized, cross-over study design where participants were studied after 2 weeks of activation or inactivation of vagal nerve blockade (VNB). Seven obese subjects with impaired fasting glucose previously enrolled in a long-term study to examine the effect of VNB on weight took part. We used a standardized triple-tracer mixed meal to enable measurement of the rate of meal appearance, endogenous glucose production, and glucose disappearance. The 550 kcal meal was also labeled with 111In-diethylene triamine pentaacetic acid (DTPA) to measure gastrointestinal transit. Insulin action and β-cell responsivity indices were estimated using the minimal model. Results: Integrated glucose, insulin, and glucagon concentrations did not differ between study days. This was also reflected in a lack of effect on β-cell responsivity and insulin action. Furthermore, fasting and postprandial endogenous glucose production, integrated meal appearance, and glucose disposal did not differ in the presence or absence of VNB. Similarly, gastric emptying and colonic transit were unchanged by VNB. Conclusion: In this pilot study in nondiabetic humans, electrical vagal blockade had no acute effects on glucose metabolism, insulin secretion and action, or gastric emptying. It remains to be determined if more pronounced effects would be observed in diabetic subjects. © 2014 Sathananthan et al.

Himes S.M.,Brown University | Grothe K.B.,Mayo Medical School | Clark M.M.,Mayo Medical School | Swain J.M.,Scottsdale Healthcare Bariatric Center | And 2 more authors.
Obesity Surgery | Year: 2015

Background: A subset of bariatric patients fails to achieve or maintain long-term successful weight loss. Psychological and behavioral factors contributing to poor long-term outcomes include decreased adherence to surgical eating guidelines, life stressors that derail weight maintenance, unhealthy eating patterns, and substance use.Objectives: A 6-week pilot group behavioral intervention utilizing techniques of cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT) was developed to treat bariatric patients experiencing weight regain.Setting: Patients were treated at a large Midwestern academic medical center.Methods: Twenty-eight patients (93 % female, 100 % Caucasian) with a mean age of 53 and a mean BMI of 35.6 had regained an average of 17 kg or 37 % of the weight lost after initially successful Roux-en-Y gastric bypass (RYGB). All patients completed the Structured Clinical Interview for DSM-IV-TR (SCID I) modules assessing mood and substance dependence, and completed a series of questionnaires before and after group treatment, with weekly assessment of depressive symptoms, binge eating, and alcohol use. Results were analyzed utilizing repeated measures ANOVA.Results: Weight decreased during the intervention by an average of 1.6 ± 2.38 kg (p ≤ 0.01). Level of depressive symptoms improved for treatment completers (p ≤ 0.01). Food records indicated that grazing patterns decreased (p ≤ 0.01) and subjective binge eating episodes decreased (p ≤ 0.03).Conclusions: A 6-week pilot group behavioral intervention demonstrated an ability to help patients reverse their pattern of weight regain. Tailored behavioral interventions may be a useful treatment to enhance maintenance of long-term weight loss. © 2015, Springer Science+Business Media New York.

Ponce J.,Chattanooga Bariatrics | Ponce J.,Hamilton Weight Management Center | Woodman G.,MidSouth Bariatrics | Swain J.,Scottsdale Healthcare Bariatric Center | And 10 more authors.
Surgery for Obesity and Related Diseases | Year: 2015

Background Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake. Objective: To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone. Setting: Academic and community practice, United States. Methods Participants (n = 326) with body mass index (BMI) 30-40 kg/m2 were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment. Results Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT, P =.004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P<.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%). Conclusion The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile. © 2015 American Society for Bariatric Surgery. All rights reserved.

Kumar S.,Mayo Medical School | Zarroug A.E.,Mayo Medical School | Swain J.M.,Scottsdale Healthcare Bariatric Center
Abdominal Imaging | Year: 2012

Overall it is clear that bariatric surgical intervention in appropriately selected adolescents is effective at both adequate weight loss and resolution of weight related co-morbidities in the short and medium term. Long-term results are being conducted currently to assess durability of bariatric surgical interventions. We believe that adolescents undergoing bariatric evaluation have unique needs and until more long-term data are available, the indications for surgery should be stricter than those used in adults. All of the bariatric procedures discussed must be performed in the background of positive behavioral modifications over a period of time. If lifestyle modification fails, these adolescents can gain weight by overcoming the physiologic effects of the surgery as they eat high calorie foods at very frequent intervals. Finally, close postoperative follow-up is required with active management of weight loss/gain, co-morbidities, and postoperative complications should they occur. © Springer Science+Business Media, LLC 2012.

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