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Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial.
Simonson, DC, Vernon, A, Foster, K, Halperin, F, Patti, ME, Goldfine, AB
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2019;(12):2052-2059
Abstract
BACKGROUND Few randomized trials have compared surgical versus lifestyle and pharmacologic approaches for type 2 diabetes (T2D) patients with mild to moderate obesity. OBJECTIVES This study examined resolution of hyperglycemia (A1C <6.5% and fasting glucose <126 mg/dL) 3 years after randomization to either a laparoscopic adjustable gastric band (LAGB) or 1-year diabetes and weight management (DWM) program. SETTING University medical center, United States. METHODS Forty T2D patients (mean ± SD: age, 51.3 ±10.0 yr; weight 109.5 ± 15.0 kg; body mass index [BMI] 36.5 ± 3.7 kg/m2; HBA1C 8.2% ± 1.2%) were randomized to LAGB (n = 18) or DWM (n = 22). RESULTS At 3 years, 13% of 16 patients in LAGB and 5% of 17 patients in DWM achieved resolution of hyperglycemia (P = .601), with a modestly greater reduction in antidiabetic medications in the surgical group (P = .054). Reductions from baseline in A1C were sustained at 3 years in LAGB (-.82% [95% CI: -1.62 to -.01], P = .046) compared with DWM (+.23% [95% CI: -.57 to 1.03], P = .567). The surgical group had greater weight loss (-12.0 kg [95% CI: -15.9 to -8.1] versus -4.8 [95% CI: -8.6 to -.9], P = .010). HDL-cholesterol increased more after surgery (P = .003), but changes in triglycerides, LDL-cholesterol, and blood pressure did not differ between treatments. Diabetes- and obesity-specific quality of life improved comparably with both therapies. CONCLUSIONS Achievement of American Diabetes Association targets for glucose, lipids, and blood pressure was similar with both treatment strategies. LAGB leads to greater sustained weight loss and higher HDL cholesterol compared with a DWM program. These findings may help guide patients with T2D and obesity when exploring options for diabetes and weight management.
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Predictive Value of Gut Peptides in T2D Remission: Randomized Controlled Trial Comparing Metabolic Gastric Bypass, Sleeve Gastrectomy and Greater Curvature Plication.
Casajoana, A, Pujol, J, Garcia, A, Elvira, J, Virgili, N, de Oca, FJ, Duran, X, Fernández-Veledo, S, Vendrell, J, Vilarrasa, N
Obesity surgery. 2017;(9):2235-2245
Abstract
BACKGROUND Our aim was to determine the predictive value of gut hormone changes for the improvement of type 2 diabetes (T2D) following metabolic Roux-en-Y gastric bypass (mRYGB), sleeve gastrectomy (SG), and greater curvature plication (GCP) in a randomized controlled trial. Contradictory results have been obtained regarding the role of gastrointestinal hormones (in particular GLP-1) in beneficial metabolic bariatric surgery outcomes. METHODS Forty-five patients with T2D (mean BMI 39.4 ± 1.9 kg/m2) were randomly assigned to mRYGB, SG, or GCP. Anthropometric and biochemical parameters, fasting concentrations of PYY, ghrelin, glucagon, and area under the curve (AUC) of GLP-1 after a standard meal test were determined prior to and at months 1 and 12 after surgery. RESULTS Twelve months after surgery, total weight loss percentage was higher and HbA1c lower in the mRYGB group than in the SG and GCP groups (-35.2 ± 8.1 and 5.1 ± 0.6% vs. -27.8 ± 5.4 and 6.2 ± 0.8% vs. -20.5 ± 6.8 and 6.6 ± 1.3%; p = 0.007 and p < 0.001, respectively). Moreover, GLP-1 AUC at months 1 and 12 was greater and T2D remission was higher in mRYGB (80 vs. 53.3 vs. 20%, p < 0.001). Insulin treatment (odds ratio (OR) 0.025, p = 0.018) and the increase in GLP-1 AUC from baseline to month 1 (OR 1.021, p = 0.013) were associated with T2D remission. CONCLUSIONS mRYGB achieves a superior rate of weight loss and T2D remission at month 12. Enhanced GLP-1 secretion 1 month after surgery was a determinant of glucose metabolism improvement. Registration number ( http://www.clinicaltrials.gov ): NCT14104758.
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Randomized controlled trial comparing laparoscopic greater curvature plication versus laparoscopic sleeve gastrectomy.
Grubnik, VV, Ospanov, OB, Namaeva, KA, Medvedev, OV, Kresyun, MS
Surgical endoscopy. 2016;(6):2186-91
Abstract
BACKGROUND Laparoscopic greater curvature plication (LGCP) is a new restrictive bariatric procedure, which has a similar restrictive mechanism like laparoscopic sleeve gastrectomy (LSG) without potential risk of leak. Aim of the study was to compare 2-year outcomes of LSG and LGCP. METHODS Multicenter prospective randomized trial was started in 2010. A total of 54 patients with morbid obesity were allocated either to LGCP group (n = 25) or LSG group (n = 27). Main exclusion criteria were: ASA > III, age > 75 and BMI > 65 kg/m(2). There were 40 women and 12 men, and the mean age was 42.6 ± 6.8 years (range 35-62). Data on the operation time, complications, hospital stay, body mass index loss, percentage of excess weight loss (%EWL), loss of appetite and improvement in comorbidities were collected during the follow-up examinations. RESULTS All procedures were completed laparoscopically. The mean operative time was 92.0 ± 15 min for LSG and 73 ± 19 min for LGCP (p > 0.05). The mean hospital stay was 4.0 ± 1.9 days in the LSG group and 3.8 ± 1.7 days in LGCP group (p > 0.05). One year after surgery, the mean %EWL was 59.5 ± 15.4 % in LSG group and 45.8 ± 17 % in LGCP group (p > 0.05). After 2 years, mean %EWL was 78.9 ± 20 % in the LSG group and 42.4 ± 18 % in the LGCP group (p < 0.01). After 3 years, mean %EWL was 72.8 ± 22 in the LSG group and only 20.5 ± 23.9 in the LGCP group (p < 0.01). Loss of feeling of hunger after 2 years was 25 % in LGCP group and 76.9 % in the LSG group (p < 0.05). The comorbidities including diabetes, sleep apnea and hypertension were markedly improved in the both groups after surgery. CONCLUSION The short-term outcomes demonstrated equal effectiveness of the both procedures, but 2-year follow-up showed that LGCP is worse than LSG as a restrictive procedure for weight loss.
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Impact of Roux-en-Y gastric bypass versus sleeve gastrectomy on vitamin D metabolism: short-term results from a prospective randomized clinical trial.
Vix, M, Liu, KH, Diana, M, D'Urso, A, Mutter, D, Marescaux, J
Surgical endoscopy. 2014;(3):821-6
Abstract
PURPOSE To assess postoperative outcomes of sleeve gastrectomy (SG) versus Roux-en-Y gastric bypass (RYGB). Short-term results on vitamin D and parathormone (PTH) metabolism are reported. METHODS One hundred patients were randomly assigned to RYGB (n = 45) or SG (n = 55). Vitamin D, PTH, and calcium were assessed at inclusion and after 1, 3, 6, and 12 months (M1, M3, M6, and M12). Eighty-eight patients completed 1-year follow-up. RESULTS Mean postoperative excess weight loss (%EWL) at M1, M3, M6, and M12 was 25.39, 43.47, 63.75, and 80.38 % versus 25.25, 51.32, 64.67, and 82.97 % in RYGB and SG, respectively. Vitamin D values were statistically significantly higher after SG compared to RYGB at M3 (61.57 pmol/L, standard deviation [SD] 14.29 vs. 54.81 SD 7.65; p = 0.01) and M12 (59.83 pmol/L, SD 6.41 vs. 56.15 SD 8.18; p = 0.02). Vitamin D deficiency rate decreased from 84.62 to 35 % at M6 (p = 0.04) and 48 % at M12 (p = 0.01) in the SG group, while there was no significant improvement in the RYGB group. Serum parathyroid hormone (sPTH) level was decreased significantly in the SG group by M3 (44.8 ng/L vs. 28.6; p = 0.03), M6 (44.9 ng/L vs. 25.8; p = 0.017), and M12 (41.4 ng/L vs. 20.5; p = 0.017). Secondary hyperparathyroidism rate was 20.83 and 24 % at M1 (p = 1), 16.67 and 8 % at M3 (p = 0.41), 14.29 and 0 % at M6 (p = 0.08), and 15 and 0 % at M12 (p = 0.23) in the RYGB and SG groups, respectively. CONCLUSIONS Patients after RYGB had a significantly higher postoperative vitamin D deficiency and higher sPTH levels than after SG.
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Long-term results of a randomized trial comparing banded versus standard laparoscopic Roux-en-Y gastric bypass.
Zarate, X, Arceo-Olaiz, R, Montalvo Hernandez, J, García-García, E, Pablo Pantoja, J, Herrera, MF
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2013;(3):395-7
Abstract
BACKGROUND Banded Roux-en-Y gastric bypass was designed to avoid or diminish weight regain in the long term. In 2008, we published the initial results of a pilot study design to comparatively evaluate surgical morbidity, mortality, and maximum weight loss in patients undergoing banded and unbanded laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study analyzes the 5-year results. METHODS A randomized, controlled trial was carried out in 60 morbidly obese patients who underwent LRYGB. Patients were divided in 2 groups. Half of the patients underwent the banded version of the LRYGB, and half underwent the unbanded version. The 5-year excess weight loss (EWL) and loss of body mass index (BMI) were comparatively analyzed. RESULTS There were 58 females and 2 males with a mean preoperative BMI of 47±4.9 kg/m(2). A total of 21 patients with banded LRYGB and 22 with unbanded LRYGB completed 5-year follow-up. One patient died 3 years after surgery from metastatic melanoma. EWL at 5 years was 61.6%±19.6% versus 59.8%±15.9% (P = ns), and loss of BMI was 32.9%±5.2% versus 32.8%±4.3% (P = ns), respectively, for the banded and unbanded group. CONCLUSIONS In this small study, there were no statistical differences in the EWL and the BMI lost at 5 years between the group of patients who underwent banded and unbanded LRYGB.
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A pilot study investigating the efficacy of postoperative dietary counseling to improve outcomes after bariatric surgery.
Sarwer, DB, Moore, RH, Spitzer, JC, Wadden, TA, Raper, SE, Williams, NN
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2012;(5):561-8
Abstract
BACKGROUND Bariatric surgery is a powerful treatment of severe obesity. During the past several years, a greater appreciation for the need for multidisciplinary care to optimize outcomes has developed, and a number of studies have been started to examine the role of postoperative interventions used in combination with surgery. The purpose of the present study was to investigate the hypothesis that the provision of postoperative dietary counseling, delivered by a registered dietitian, would lead to greater weight loss and more positive improvements in dietary intake and eating behavior compared with standard postoperative care. The study was performed at an academic medical center. METHODS Eighty-four individuals who underwent bariatric surgery were randomly assigned to receive either dietary counseling or standard postoperative care for the first 4 months after surgery. The participants completed measures of macronutrient intake and eating behavior at baseline and 2, 4, 6, 12, 18, and 24 months after surgery. RESULTS The patients who received dietary counseling achieved greater weight loss than those who received standard postoperative care that did not involve this counseling, although this difference did not reach statistical significance. Patients in the dietary counseling arm did report significant changes in several eating behaviors believed to be important to successful long-term weight maintenance. CONCLUSION The results of our pilot study provide some support for the efficacy of early postoperative dietary counseling to improve outcomes after bariatric surgery.
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Does a preoperative medically supervised weight loss program improve bariatric surgery outcomes? A pilot randomized study.
Parikh, M, Dasari, M, McMacken, M, Ren, C, Fielding, G, Ogedegbe, G
Surgical endoscopy. 2012;(3):853-61
Abstract
BACKGROUND Many insurance payors mandate that bariatric surgery candidates undergo a medically supervised weight management (MSWM) program as a prerequisite for surgery. However, there is little evidence to support this requirement. We evaluated in a randomized controlled trial the hypothesis that participation in a MSWM program does not predict outcomes after laparoscopic adjustable gastric banding (LAGB) in a publicly insured population. METHODS This pilot randomized trial was conducted in a large academic urban public hospital. Patients who met NIH consensus criteria for bariatric surgery and whose insurance did not require a mandatory 6-month MSWM program were randomized to a MSWM program with monthly visits over 6 months (individual or group) or usual care for 6 months and then followed for bariatric surgery outcomes postoperatively. Demographics, weight, and patient behavior scores, including patient adherence, eating behavior, patient activation, and physical activity, were collected at baseline and at 6 months (immediately preoperatively and postoperatively). RESULTS A total of 55 patients were enrolled in the study with complete follow-up on 23 patients. Participants randomized to a MSWM program attended an average of 2 sessions preoperatively. The majority of participants were female and non-Caucasian, mean age was 46 years, average income was less than $20,000/year, and most had Medicaid as their primary insurer, consistent with the demographics of the hospital's bariatric surgery program. Data analysis included both intention-to-treat and completers' analyses. No significant differences in weight loss and most patient behaviors were found between the two groups postoperatively, suggesting that participation in a MSWM program did not improve weight loss outcomes for LAGB. Participation in a MSWM program did appear to have a positive effect on physical activity postoperatively. CONCLUSION MSWM does not appear to confer additional benefit as compared to the standard preoperative bariatric surgery protocol in terms of weight loss and most behavioral outcomes after LAGB in our patient population.
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A pilot study comparing jejunal pouch and jejunal interposition reconstruction after proximal gastrectomy.
Takagawa, R, Kunisaki, C, Kimura, J, Makino, H, Kosaka, T, Ono, HA, Akiyama, H, Endo, I
Digestive surgery. 2010;(6):502-8
Abstract
BACKGROUND/AIMS: The incidence of proximal gastric cancer is increasing, so proximal gastrectomies are often performed to preserve gastric function, but the optimal reconstruction method after surgery remains controversial. We therefore conducted a prospective pilot study comparing reconstructions using jejunal pouch interposition or jejunal interposition. METHODS Thirty-eight patients with early proximal gastric cancer were included in this study. Equal numbers of patients were randomly assigned for reconstruction using jejunal interposition (the IP group) or jejunal pouch interposition (the PO group). Postoperative morbidity and patient symptoms were compared between the 2 groups. RESULTS Postoperative morbidity was significantly more frequent in the IP than the PO group (p = 0.036). Moreover, the incidence of gastrointestinal complaints was more frequent in the IP group until 6 months after surgery. By contrast, the caloric intake was more favorable in the PO group until 1 year post-surgery. CONCLUSION Short-term and mid-term outcomes were more favorable following jejunal pouch interposition compared with jejunal interposition after proximal gastrectomy.
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Growth hormone treatment prevents loss of lean mass after bariatric surgery in morbidly obese patients: results of a pilot, open, prospective, randomized, controlled study.
Savastano, S, Di Somma, C, Angrisani, L, Orio, F, Longobardi, S, Lombardi, G, Colao, A
The Journal of clinical endocrinology and metabolism. 2009;(3):817-26
Abstract
CONTEXT The loss of lean body mass (LBM) negatively influences the outcome in bariatric surgery. Impaired GH secretion is frequent in obese patients. OBJECTIVE Our objective was to investigate if GH treatment prevents LBM loss in the early postoperative period. DESIGN This was an open, prospective, randomized, and controlled study. PATIENTS A total of 24 women (body mass index: 44.4 +/- 7.6 kg/m(2), aged 36.8 +/- 11.7 yr) undergoing laparoscopic-adjustable silicone gastric banding (LASGB) and with GH deficiency after LASGB was included in the study. TREATMENT PROTOCOL Group A (n = 12) included a standardized diet regimen and exercise program plus recombinant human GH (0.5 +/- 0.13 mg every day), and group B (n = 12) included a standardized diet regimen and exercise program. The follow-up duration was 6 months. RESULTS The excess of body weight loss did not differ between groups A and B after 3 and 6 months. At 3 months, LBM loss was lower (P < 0.0001) and fat mass (FM) loss was higher (P = 0.02) in group A than group B. At 3 and 6 months, appendicular skeletal muscle mass loss was lower (P = 0.000) in group A than group B. At 3 (P = 0.0003 and 0.0005, respectively) and 6 months (P < 0.0001 and 0.0002, respectively), the percent changes of FM and lean body mass were significantly higher in group A than group B. In both groups fasting and postglucose area under the plasma concentration-time curve insulin significantly reduced. The homeostasis model assessment of insulin and insulin sensitivity indexes and total to high-density lipoprotein cholesterol ratio improved only in group A. CONCLUSIONS GH treatment for 6 months after LASGB reduces loss in LBM and appendicular skeletal muscle mass during a standardized program of low-calorie diet and physical exercise program, with improvement of lipid profile and without a deterioration of glucose tolerance.
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Body composition, dietary intake, and energy expenditure after laparoscopic Roux-en-Y gastric bypass and laparoscopic vertical banded gastroplasty: a randomized clinical trial.
Olbers, T, Björkman, S, Lindroos, A, Maleckas, A, Lönn, L, Sjöström, L, Lönroth, H
Annals of surgery. 2006;(5):715-22
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Abstract
OBJECTIVE To assess body composition, eating pattern, and basal metabolic rate in patients undergoing obesity surgery in a randomized trial. INTRODUCTION There is limited knowledge regarding how different bariatric surgical techniques function in terms of altering body composition, dietary intake, and basic metabolic rate. METHODS Non-superobese patients were randomized to laparoscopic Roux-en-Y gastric bypass (LGBP, n = 37) or laparoscopic vertical banded gastroplasty (LVBG, n = 46). Anthropometry, dual-energy x-ray absorptiometry (DEXA), computed tomography (CT), indirect calorimetry, and reported dietary intake were registered prior to and 1 year after surgery. RESULTS Follow-up rate was 97.6%. LGBP patients had significantly greater reduction of waist circumference and sagittal diameter compared with LVBG. DEXA demonstrated a larger reduction of body fat in all compartments after LGBP, especially at the trunk (P<0.001). CT demonstrated more reduction of the visceral fat (P=0.016). Patients were able to eat all types of food after LGBP, although about 30% claimed they avoided fats. LGBP patients decreased their proportion of dietary fat significantly more than those operated on with LVBG (P = 0.005), who consumed more sweet foods and avoided whole meat and vegetables. Lean tissue mass (LTM) was proportionally less reduced, especially in men, after LGBP. The decreases in BMR postoperatively reflected the lower body mass in a pattern that did not differ among the groups. CONCLUSION LGBP patients demonstrated better outcomes compared with LVBG patients in terms of body composition. Energy expenditure developed as expected postoperatively. A "steering" away from fatty foods after LGBP may be an important mechanism of action in gastric bypass.