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PREVENT: A Randomized, Placebo-controlled Crossover Trial of Avexitide for Treatment of Postbariatric Hypoglycemia.
Craig, CM, Lawler, HM, Lee, CJE, Tan, M, Davis, DB, Tong, J, Glodowski, M, Rogowitz, E, Karaman, R, McLaughlin, TL, et al
The Journal of clinical endocrinology and metabolism. 2021;(8):e3235-e3248
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Abstract
CONTEXT Postbariatric hypoglycemia (PBH), characterized by enteroinsular axis overstimulation and hyperinsulinemic hypoglycemia, is a complication of bariatric surgery for which there is no approved therapy. OBJECTIVE To evaluate efficacy and safety of avexitide [exendin (9-39)], a glucagon-like peptide-1 antagonist, for treatment of PBH. METHODS A multicenter, Phase 2, randomized, placebo-controlled crossover study (PREVENT). Eighteen female patients with PBH were given placebo for 14 days followed by avexitide 30 mg twice daily and 60 mg once daily, each for 14 days in random order. The main outcome measures were glucose nadir and insulin peak during mixed-meal tolerance testing (MMTT) and hypoglycemic events captured by self-monitoring of blood glucose (SMBG), electronic diary, and blinded continuous glucose monitoring (CGM). RESULTS Compared with placebo, avexitide 30 mg twice daily and 60 mg once daily raised the glucose nadir by 21% (P = .001) and 26% (P = .0002) and lowered the insulin peak by 23% (P = .029) and 21% (P = .042), corresponding to 50% and 75% fewer participants requiring rescue during MMTT, respectively. Significant reductions in rates of Levels 1 to 3 hypoglycemia were observed, defined, respectively, as SMBG <70 mg/dL, SMBG <54 mg/dL, and a severe event characterized by altered mental and/or physical function requiring assistance. CGM demonstrated reductions in hypoglycemia without induction of clinically relevant hyperglycemia. Avexitide was well tolerated, with no increase in adverse events. CONCLUSION Avexitide administered for 28 days was well tolerated and resulted in robust and consistent improvements across multiple clinical and metabolic parameters, reinforcing the targeted therapeutic approach and demonstrating durability of effect. Avexitide may represent a first promising treatment for patients with severe PBH.
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Fracture risk after three bariatric surgery procedures in Swedish obese subjects: up to 26 years follow-up of a controlled intervention study.
Ahlin, S, Peltonen, M, Sjöholm, K, Anveden, Å, Jacobson, P, Andersson-Assarsson, JC, Taube, M, Larsson, I, Lohmander, LS, Näslund, I, et al
Journal of internal medicine. 2020;(5):546-557
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Abstract
BACKGROUND Previous studies have reported an increased fracture risk after bariatric surgery. OBJECTIVE To investigate the association between different bariatric surgery procedures and fracture risk. METHODS Incidence rates and hazard ratios for fracture events were analysed in the Swedish Obese Subjects study; an ongoing, nonrandomized, prospective, controlled intervention study. Hazard ratios were adjusted for risk factors for osteoporosis and year of inclusion. Information on fracture events were captured from the Swedish National Patient Register. The current analysis includes 2007 patients treated with bariatric surgery (13.3% gastric bypass, 18.7% gastric banding, and 68.0% vertical banded gastroplasty) and 2040 control patients with obesity matched on group level based on 18 variables. Median follow-up was between 15.1 and 17.9 years for the different treatment groups. RESULTS During follow-up, the highest incidence rate for first-time fracture was observed in the gastric bypass group (22.9 per 1000 person-years). The corresponding incidence rates were 10.4, 10.7 and 9.3 per 1000 person-years for the vertical banded gastroplasty, gastric banding and control groups, respectively. The risk of fracture was increased in the gastric bypass group compared with the control group (adjusted hazard ratio [adjHR] 2.58; 95% confidence interval [CI] 2.02-3.31; P < 0.001), the gastric banding group (adjHR 1.99; 95%CI 1.41-2.82; P < 0.001), and the vertical banded gastroplasty group (adjHR 2.15; 95% CI 1.66-2.79; P < 0.001). CONCLUSIONS The risk of fracture is increased after gastric bypass surgery. Our findings highlight the need for long-term follow-up of bone health for patients undergoing this treatment.
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Outcomes of bariatric surgery in patients with depression disorders.
Susmallian, S, Nikiforova, I, Azoulai, S, Barnea, R
PloS one. 2019;(8):e0221576
Abstract
OBJECTIVE To determine the impact of sleeve gastrectomy in patients suffering from depression compared with those who are not in a depressive state. INTRODUCTION Obesity is considered a global epidemic. Often patients with obesity suffer from depressive state. Depressive disorders may be both a cause and a consequence of obesity. MATERIAL AND METHODS The study includes 300 consecutives patients that underwent laparoscopic sleeve gastrectomy. Out of the 300 patients, 253 (84.33%) of them completed the follow up for three years. RESULTS Out of the 300-patients, with the average age of 41.65±11.05 years old, the ratio of males to females was 1:2. The average baseline BMI was 42.02 kg/m2. A total of 105 (35.33%) of the patients suffer from depression, which was more common in male (43%) than in female (31.5%), with statistically significant difference (p = .05). Comparing the weight loss after surgery in both groups, the mean weight loss in the depression-group was 12.0 ΔBMI and in the non-depression group was 13.03 ΔBMI, (p< .001). After three years, 94 (88.68%) patients of the depression group responded as they were optimistic and satisfied with the results of the operation, with positive changes in their lives, 8 (7.55%) did not experience change and 4 (3.77%) expressed to have worsened their depressive state. CONCLUSION Laparoscopic sleeve gastrectomy is successful and leads to weight loss even in subjects who are affected by depression syndrome.
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Haemostatic and fibrinolytic changes in obese subjects undergoing bariatric surgery: the effect of different surgical procedures.
Lupoli, R, Milone, M, Di Minno, A, Maietta, P, Ambrosino, P, Musella, M, Di Minno, MN
Blood transfusion = Trasfusione del sangue. 2015;(3):442-7
Abstract
BACKGROUND Little is known about effects of different bariatric surgery procedures on haemostatic and fibrinolytic parameters. MATERIAL AND METHODS Consecutive obese subjects undergoing gastric bypass (GBP) or sleeve gastrectomy (SG) were enrolled. In all patients, levels of haemostatic factors (FII, FVII, FVIII, FIX, FX, vWF, fibrinogen), fibrinolytic variables (PAI-1, t-PA and D-dimer) and natural anticoagulants (AT, protein C and protein S) were evaluated before and 2 months after surgery. RESULTS A total of 77 GBP and 79 SG subjects completed the study. At baseline no difference in coagulation parameters was found between the two groups. After both GBP and SG, subjects showed significant changes in haemostatic and fibrinolytic variables and in natural anticoagulant levels. The Δ% changes in FVII, FVIII, FIX, vWF, fibrinogen, D-dimer, protein C and protein S levels were significantly higher in subjects who underwent GBP than in those who underwent SG. Multivariate analysis confirmed that GBP was a predictor of higher Δ% changes in FVII (β=0.268, p=0.010), protein C (β=0.274, p=0.003) and protein S (β=0.297, p<0.001), but not in all the other variables. Following coagulation factor reduction, 31 subjects (25.9% of GBP and 13.9% of SG; p=0.044) showed overt FVII deficiency; protein C deficiency was reported by 34 subjects (32.5% of GBP vs 11.4% of SG, p=0.033) and protein S deficiency by 39 (37.6% of GBP vs 12.6% of SG, p=0.009). Multivariate analyses showed that GBP was associated with an increased risk of deficiency of FVII (OR: 3.64; 95% CI: 1.73-7.64, p=0.001), protein C (OR: 4.319; 95% CI: 1.33-13.9, p=0.015) and protein S (OR: 5.50; 95% CI: 1.71-17.7, p=0.004). DISCUSSION GBP is associated with an increased risk of post-operative deficiency in some vitamin K-dependent coagulation factors. Whereas such deficiency is too weak to cause bleeding, it is significant enough to increase the risk of thrombosis.
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Changes in obesity-related diseases and biochemical variables after laparoscopic sleeve gastrectomy: a two-year follow-up study.
Våge, V, Sande, VA, Mellgren, G, Laukeland, C, Behme, J, Andersen, JR
BMC surgery. 2014;:8
Abstract
BACKGROUND To evaluate changes in obesity-related diseases and micronutrients after laparoscopic sleeve gastrectomy (LSG). METHODS We started the procedure in May 2007, and by December 2011, 117 patients could be evaluated for a two year follow-up. Comparisons of preoperative status with 12 and 24 months postoperative status were made for body mass index (BMI), obesity-related diseases and micronutrients. RESULTS Major complications included bleeding requiring transfusion at 5.1%, leak at 1.7% and abscess without a visible leak at 0.9%. Mean BMI was reduced from 46.6 (standard deviation (SD) 6.0) kg/m2 to 30.6 (SD 5.6) kg/m2 at two years, and resolution occurred for 80.7% of patients with type 2 diabetes, 63.9% with hypertension, 75.8% with hyperlipidemia, 93.0% with sleep apnea, 31.4% with musculoskeletal pain, 85.4% with snoring and 73.3% with urinary incontinence. Amenorrhea resolved in all premenopausal females. The proportion of patients with symptomatic gastroesophageal reflux disease increased from 12.8% to 27.4%. The prevalence of patients with low ferritin-levels increased, while 25-hydroxyvitamin D (25(OH)D) deficiency decreased postoperatively. CONCLUSIONS LSG is an effective procedure for morbid obesity and obesity-related diseases, but the technique should be further explored particularly to avoid gastroesophageal reflux.
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Preliminary results from digestive adaptation: a new surgical proposal for treating obesity, based on physiology and evolution.
Santoro, S, Velhote, MC, Malzoni, CE, Milleo, FQ, Klajner, S, Campos, FG
Sao Paulo medical journal = Revista paulista de medicina. 2006;(4):192-7
Abstract
CONTEXT AND OBJECTIVE Most bariatric surgical techniques include essentially non-physiological features like narrowing anastomoses or bands, or digestive segment exclusion, especially the duodenum. This potentially causes symptoms or complications. The aim here was to report on the preliminary results from a new surgical technique for treating morbid obesity that takes a physiological and evolutionary approach. DESIGN AND SETTING Case series description, in Hospital Israelita Albert Einstein and Hospital da Polícia Militar, São Paulo, and Hospital Vicentino, Ponta Grossa, Paraná. METHODS The technique included vertical (sleeve) gastrectomy, omentectomy and enterectomy that retained three meters of small bowel (initial jejunum and most of the ileum), i.e. the lower limit for normal adults. The operations on 100 patients are described. RESULTS The mean follow-up was nine months (range: one to 29 months). The mean reductions in body mass index were 4.3, 6.1, 8.1, 10.1 and 10.7 kg/m2, respectively at 1, 2, 4, 6 and 12 months. All patients reported early satiety. There was major improvement in comorbidities, especially diabetes. Operative complications occurred in 7% of patients, all of them resolved without sequelae. There was no mortality. CONCLUSIONS This procedure creates a proportionally reduced gastrointestinal tract, leaving its basic functions unharmed and producing adaptation of the gastric chamber size to hypercaloric diet. It removes the sources of ghrelin, plasminogen activator inhibitor-1 (PAI-1) and resistin production and leads more nutrients to the distal bowel, with desirable metabolic consequences. Patients do not need nutritional support or drug medication. The procedure is straightforward and safe.