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.
Ponce J.,Chattanooga Bariatrics |
Ponce J.,Hamilton Weight Management Center |
Woodman G.,MidSouth Bariatrics |
Woodman G.,Baptist Memorial Hospital |
And 11 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.
Ikramuddin S.,University of Minnesota |
Blackstone R.P.,University of Minnesota |
Blackstone R.P.,Scottsdale Healthcare Bariatric Center |
Brancatisano A.,Institute of Weight Control |
And 22 more authors.
JAMA - Journal of the American Medical Association | Year: 2014
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, havingmet the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976. Copyright 2014 American Medical Association. All rights reserved.
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.
PubMed | ETHICON,Inc., S2 Statistical Solutions, Harvard University and Scottsdale Healthcare Bariatric Center
Type: Journal Article | Journal: JAMA surgery | Year: 2016
Little is known about comorbidity remission after bariatric surgery during typical clinical care across diverse and geographically distributed populations.To estimate the improvement in obesity-related comorbidities after bariatric surgery and to identify clinical factors associated with these responses using a large representative population of patients.This retrospective cohort study included all patients (N= 33,718) with a recorded Current Procedural Terminology code for Roux-en-Y gastric bypass (RYGB) or adjustable gastric banding (AGB) in the MarketScan Commercial Claims and Encounters Medicare Supplemental Databases from January 1, 2005, to June 30, 2010, and who had continuous enrollment from 6 months or more before to 12 months after surgery.Comorbidities before and after surgery were identified using both diagnoses (from International Classification of Diseases, Ninth Revision [ICD-9] codes) and prescription drug fills. Remission was based on a record of the comorbidity within 6 months before surgery, without record of the condition 18 months after surgery, using both ICD-9 codes and medication fills, as applicable. Multivariable logistic regression models were developed to identify factors associated with remission of diabetes and hypertension.Among the 33,718 patients, 13 comorbidities with at least 1% prevalence before surgery were identified. Both RYGB and AGB led to statistically and clinically significant reductions in these comorbidities; remission rates for all comorbidities were higher after RYGB than AGB. For comorbidities that could be defined using both ICD-9 and prescription drug fill codes, prevalence was higher before and lower after surgery when measured by fill codes. Diagnoses using ICD-9 codes, but not prescription fill codes, increased in the 3 months before surgery. In multivariable logistic regression models for remission of diabetes mellitus after RYGB and AGB, age (RYGB: odds ratio [OR], 0.976; 95% CI, 0.965-0.988 and AGB: OR, 0.982; 95% CI, 0.971-0.933), procedure year (RYGB: OR, 1.11; 95% CI, 1.012-1.218 and AGB: OR, 1.185; 95% CI, 1.039-1.351), preoperative insulin use (RYGB: OR, 0.14; 95% CI, 0.114-0.171; AGB: OR, 0.174; 95% CI, 0.131-0.230), preoperative sulfonylurea use (RYGB: OR, 0.616; 95% CI, 0.505-0.752 and AGB: OR, 0.449; 95% CI, 0.357-0.566), and other antidiabetic medication use (RYGB: OR, 0.747; 95% CI, 0.568-0.981 and AGB: OR, 0.506; 95% CI, 0.359-0.715) were significantly associated with response after both procedures. For remission of hypertension, age (RYGB: OR, 0.964; 95% CI, 0.957-0.972 and AGB: OR, 0.968; 95% CI, 0.959-0.977), number of preoperative antihypertensive medications (RYGB: OR, 0.104; 95% CI, 0.067-0.161 and AGB: OR, 0.239; 95% CI, 0.140-0.408), and preoperative diuretic use (RYGB: OR, 1.729; 95% CI, 1.462-2.045 and AGB: OR, 1.648; 95% CI, 1.380-1.967) were significantly associated with response after both procedures.Analysis of a large, representative administrative database confirmed established predictors and revealed novel variables associated with comorbidity remission after bariatric surgery. Incorporating these factors into clinical tools to assess an individual patients risk-to-benefit profile for these procedures could enhance patient selection and the overall use of surgery for the treatment of obesity and metabolic disease.
Blackstone R.,Scottsdale Healthcare Bariatric Center |
Blackstone R.,University of Arizona |
Bunt J.C.,U.S. National Institute of Diabetes and Digestive and Kidney Diseases |
Cortes M.C.,Scottsdale Healthcare Bariatric Center |
And 2 more authors.
Surgery for Obesity and Related Diseases | Year: 2012
Background: The remission rates of type 2 diabetes mellitus (T2DM) after Roux-en-Y gastric bypass (RYGB) vary according to the glycosylated hemoglobin A1c (HbA1c), fasting blood glucose (FG), and medication status. Our objectives were to describe remission using the American Diabetes Association standards for defining normoglycemia and to identify the factors related to the preoperative severity of T2DM that predict remission to normoglycemia, independent of weight loss, after RYGB. The setting was an urban not-for-profit community hospital. Methods: We performed a retrospective analysis of prospectively collected data from a cohort of 2275 patients who qualified for bariatric surgery (2001-2008). Five different models for defining remission (no diabetes medication and a FG <100 mg/dL; no diabetes medication and HbA1c <6.0; no diabetes medication and HbA1c <5.7%; no diabetes medication, FG <100 mg/dL, and HbA1c <6.0%; and no diabetes medication, FG <100 mg/dL, and HbA1c <5.7%) were compared in 505 obese patients with T2DM 14 months after RYGB. The secondary aims were to determine the effects of preoperative insulin therapy and the duration of known T2DM on remission. Results: Of the 505 patients, 43.2% achieved remission using the most stringent criteria (no diabetes medication, HbA1c <5.7%, and FG <100 mg/dL) compared with 59.4% using the most liberal definition (no diabetes medication and FG <100 mg/dL; P <.001). The remission rates were greater for patients not taking insulin preoperatively (53.8% versus 13.5%, P <.001) and for patients with a more recent preoperative T2DM diagnosis (8.9 versus 3.7 yr, P <.001). Conclusion: Remission, defined at a threshold less than what would be expected to result in microvascular damage, was achieved in 43.2% of diabetic patients by 14 months after RYGB. A more recent diagnosis of T2DM and the absence of preoperative insulin therapy were significant predictors, regardless of how remission was defined, independent of the percentage of excess weight loss. © 2012 American Society for Metabolic and Bariatric Surgery.
PubMed | Obesity & Diabetes Clinical Research Section and Scottsdale Healthcare Bariatric Center
Type: | Journal: International journal of obesity (2005) | Year: 2017
To evaluate early changes in glycemia, insulin physiology and gut hormone responses to an easily tolerated and slowly ingested solid, low-carbohydrate mixed meal (MMT) following adjustable gastric banding (LAGB) or Roux-en-Y gastric bypass (RYGB) surgery.This was a prospective non-randomized study. Plasma glucose, insulin and c-peptide (to estimate hepatic insulin extraction; %HIE), incretins (GIP, aGLP-1) and pancreatic polypeptide (PP) responses to the MMT were measured at 4-8 weeks before and after surgery in obese, metabolically healthy patients (RYGB=10F or LAGB=7F/1M). Supplementary clamp data on basal endogenous glucose production (EGP) and peripheral insulin action (Rd) and clearance (INS-MCR) were available in 5 of the RYGB patients. Repeated measures were appropriately accounted for in the analyses.Following LAGB surgery, C-peptide and insulin MMT profiles (P=0.004 and P=0.0005, respectively) were lower with no change in %HIE (P=0.98). In contrast, in RYGB subjects, both fasting glucose and insulin (=-0.66mmol/l, P0.05 and =-44.4pmol/l, P0.05 respectively) decreased, and MMT glucose (P<0.0001) and insulin (P=0.001) but not c-peptide (P=0.69) decreased. Estimated %HIE increased at fasting (=8.4%, P0.05) and during MMT (P=0.0005). Early (0 to 20min) prandial glucose (0.270.26 vs 0.0060.21mmol/l, P0.05) and insulin (63[48, 66] vs 18[12, 24] pmol/l, P0.05) responses increased after RYGB. RYGB altered the trajectory of prandial aGLP-1 responses (treatment*trajectory P=0.02), and PP was lower (P<0.0001). Clamp data in a subset of RYGB patients showed early improvement in basal EGP (P=0.001), and INS-MCR (P=0.015).RYGB results in distinctly different changes in plasma glucose, insulin, and gut hormone response patterns to a solid, slowly ingested low-carbohydrate MMT versus LAGB. Altered nutrient delivery, along with indirect evidence for changes in hepatic and peripheral insulin physiology, are consistent with the greater early improvement in glycemia observed after RYGB versus LAGB surgery.International Journal of Obesity accepted article preview online, 25 January 2017. doi:10.1038/ijo.2017.22.
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.
Santosa S.,Endocrine Research Unit |
Santosa S.,Concordia University at Montréal |
Swain J.,Mayo Medical School |
Swain J.,Scottsdale Healthcare Bariatric Center |
And 3 more authors.
International Journal of Obesity | Year: 2015
Subcutaneous adipose tissue can be obtained for research during an elective, clinically indicated operation by standard surgical excision approaches and by needle aspiration in pure research settings. Whether measurements of inflammatory markers and cells from tissues collected in these two different ways are comparable is debatable. We sought to determine whether these two techniques yield systematically different results for measurements of inflammation, cellular senescence and adipose tissue composition. Twelve subjects undergoing surgery participated. At the time of surgery abdominal subcutaneous adipose tissue from adjacent sites was removed by excision and needle aspiration. Stromovascular cell composition (flow cytometry), the number of senescent cells (senescence-associated-β-galactosidase staining) and interleukin (IL)-6, IL-1, TNF-α and MCP1 mRNA (reverse transcription-PCR) were measured in each sample. We found no statistically significant differences between the two sample-collection approaches for any of the parameters measured. We conclude that these two methods of obtaining adipose tissue do not systematically differ in the results of cytokine mRNA content, cellular senescence or stromovascular cell composition. © 2015 Macmillan Publishers Limited.
Mundi M.S.,Mayo Medical School |
Lorentz P.A.,Mayo Medical School |
Swain J.,Scottsdale Healthcare Bariatric Center |
Grothe K.,Mayo Medical School |
Collazo-Clavell M.,Mayo Medical School
Obesity Surgery | Year: 2013
Background: The prevalence of obesity is 33 % and is expected to reach 50 % based on current US trends. Bariatric surgery is effective in producing long-term weight loss, yet it requires adherence to the recommended diet and physical activity. This study assessed whether the short-form International Physical Activity Questionnaire (IPAQ-SF) data at 1 year postbariatric surgery would correlate with success (defined as more than 50 % excess weight loss (EWL)) after surgery. Methods: The IPAQ-SF questionnaire provided assessment of subjects' activity level over the last 7 days, in four separate activity domains: vigorous, moderate, walking, and sitting. Results: Questionnaires were completed and collected at the 1-year postbariatric surgery group visit. Then, 118 subjects who completed the IPAQ-SF were subdivided based on loss of greater than or less than 50 % of their excess weight, which in turn was based on ideal body weight. In subjects with ≥50% EWL (n = 49), we noted 67.1 ± 8.8 % EWL versus 33.2 ± 9.4 % in those with <50 % EWL (n = 69) (p < 0.001). The ≥50 % EWL group performed 420 (216-960) min of total activity per week versus 300 (172-718) min for the <50 % group. The ≥50 % EWL group engaged in 120 (8-180) min of vigorous activity, 150 (28-330) min of moderate activity, and 233 (109-512) min of walking versus 40 (0-255), 68 (0-204), and 188 (83-341) min, respectively, for the <50 % EWL group. Conclusions: Physical activity does correlate with success after bariatric surgery, as measured by excess weight loss (≥50 % EWL). © 2013 Springer Science+Business Media New York.