Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial.

Background: We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better. Methods: A 5 year, open-label, single-centre, randomised trial studied patients with diabetic kidney disease and class I obesity after 1:1 randomization to best medical treatment (n = 49) or RYGB (n = 51). The primary outcome was the proportion of patients achieving remission of microalbuminuria after 5 years. Secondary outcomes included improvements in diabetic kidney disease, glycemic control, quality of life, and safety. For efficacy outcomes, we performed an intention-to-treat (ITT) analysis. This study was registered with ClinicalTrials.gov, NCT01821508. Findings: 88% of patients (44 per arm) completed 5-year follow-up. Remission of albuminuria occurred in 59.6% (95% CI = 45.5-73.8) after best medical treatment and 69.7% (95% CI = 59.6-79.8) after RYGB (risk difference: 10%, 95% CI, -7 to 27, P = 0.25). Patients after RYGB were twice as likely to achieve an HbA1c ≤ 6.5% (60.2% versus 25.4%, risk difference, 34.9%; 95% CI = 15.8-53.9, P < 0.001). Quality of life after five years measured by the 36-Item Short Form Survey questionnaire (standardized to a 0-to-100 scale) was higher in the RYGB group than in the best medical treatment group for several domains. The mean differences were 13.5 (95% CI, 5.5-21.6, P = 0.001) for general health, 19.7 (95% CI, 9.1-30.3, P < 0.001) for pain, 6.1 (95% CI, -4.8 to 17.0, P = 0.27) for social functioning, 8.3 (95% CI, 0.23 to 16.3, P = 0.04) for emotional well-being, 12.2 (95% CI, 3.9-20.4, P = 0.004) for vitality, 16.8 (95% CI, -0.75 to 34.4, P = 0.06) for mental health, 21.8 (95% CI, 4.8-38.7, P = 0.01) for physical health and 11.1 (95% CI, 2.24-19.9, P = 0.01) for physical functioning. Serious adverse events were experienced in 7/46 (15.2%) after best medical treatment and 11/46 patients (24%) after RYGB (P = 0.80). Interpretation: Albuminuria remission was not statistically different between best medical treatment and RYGB after 5 years in participants with diabetic kidney disease and class 1 obesity, with 6-7 in ten patients achieving remission of microalbuminuria (uACR <30 mg/g) in both groups. RYGB was superior in improving glycemia, diastolic blood pressure, lipids, body weight, and quality of life. Funding: The study was supported by research grants from Johnson & Johnson Brasil, Oswaldo Cruz German Hospital, and by grant 12/YI/B2480 from Science Foundation Ireland (Dr le Roux) and grant 2015-02733 from the Swedish Medical Research Council (Dr le Roux). Dr Pereira was funded by the Chevening Scholarship Programme (Foreign and Commonwealth Office, UK).

Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity: A Randomized Clinical Trial.

Importance: Early-stage chronic kidney disease (CKD) characterized by microalbuminuria is associated with future cardiovascular events, progression toward end-stage renal disease, and early mortality in patients with type 2 diabetes. Objective: To compare the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) surgery vs best medical treatment in patients with early-stage CKD, type 2 diabetes, and obesity. Design, Setting, and Participants: For this randomized clinical trial, patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up. Intervention: A total of 100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 [calculated as weight in kilograms divided by height in meters squared]), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min) were randomized 1:1 to receive best medical treatment (n = 49) or RYGB (n = 51). Main Outcomes and Measures: The primary outcome was remission of albuminuria (uACR <30 mg/g). Secondary outcomes were CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety. Results: A total of 100 patients (mean [SD] age, 51.4 [7.6] years; 55 [55%] male) were randomized: 51 to RYGB and 49 to best medical care. Remission of albuminuria occurred in 55% of patients (95% CI, 39%-70%) after best medical treatment and 82% of patients (95% CI, 72%-93%) after RYGB (P = .006), resulting in CKD remission rates of 48% (95% CI, 32%-64%) after best medical treatment and 82% (95% CI, 72%-92%) after RYGB (P = .002). The geometric mean uACRs were 55% lower after RYGB (10.7 mg/g of creatinine) than after best medical treatment (23.6 mg/g of creatinine) (P < .001). No difference in the rate of serious adverse events was observed. Conclusions and Relevance: After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity. Trial Registration: ClinicalTrials.gov Identifier: NCT01821508.

Metabolic Surgery for Hypertension in Patients With Obesity.

The global prevalence of overweight and obesity has risen substantially over the past 4 decades and is accompanied by an increasing burden of cardiovascular risk factors such as hypertension. Metabolic surgery is the most effective method to treat obesity and may further improve associated conditions. Although most research has been directed toward the glycemic effects of weight loss surgery, there has been a growing interest in exploring its potential blood pressure-reducing properties. Systematic reviews and meta-analyses based primarily on observational data have suggested that metabolic surgery may aid in controlling hypertension. Only one randomized controlled trial specifically addressing this concept has been conducted, though supportive of the findings from observational studies. We review contemporary procedures for weight loss and their effects on cardiometabolic risk, particularly hypertension. In addition, we describe potential pathophysiological mechanisms and the effects of metabolic surgery on cardiovascular events and mortality.

Does the RYGB common limb length influence hypertension remission and cardiometabolic risk factors? Data from the GATEWAY trial.

BACKGROUND: Although Roux-en-Y gastric bypass (RYGB) results in significant weight loss and cardiometabolic risk factors improvements; there is no consensus whether limb lengths may influence these results. OBJECTIVE: To evaluate the correlations between the common limb length (CLL) and hypertension remission rate, cardiometabolic risk factors, and nutritional parameters after RYGB. SETTINGS: Private Hospital, Brazil. METHODS: GATEWAY is a randomized trial designed to evaluate the efficacy of RYGB on hypertension improvement and other cardiometabolic risk factors in patients with grade I and II obesity compared with medical therapy. The follow-up was 1 year. We measured the entire bowel in all patients and used a 150-cm alimentary limb and a 100-cm biliopancreatic limb. Univariate logistic regression was used to estimate the relationship between CLL and hypertension remission. Pearson and Spearman correlation were used to evaluate the correlation between the CLL and the percentage changes of cardiometabolic risk factors and nutritional parameters. RESULTS: From 100 randomized patients, 45 were submitted to RYGB and completed the follow-up. Mean CLL was 466.3 ± 86.4 cm. Of patients, 55.6% from the RYGB group showed remission of hypertension. CLL length was not significantly associated with hypertension remission (odds ratio [95% confidence interval] for 50 units increase in CLL: .97 [.68; 1.38], P = .88). Consistently, we found no correlations between CLL and all changes in cardiometabolic risk factors and nutritional parameters. CONCLUSIONS: In a proximal RYGB, CLL does not influence hypertension remission, cardiometabolic risk factors, and nutritional parameters.

Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension).

BACKGROUND: Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the impact of bariatric surgery in patients with obesity and hypertension are needed. METHODS: In this randomized, single-center, nonblinded trial, we included patients with hypertension (using ≥2 medications at maximum doses or >2 at moderate doses) and a body mass index between 30.0 and 39.9 kg/m2. Patients were randomized to Roux-en-Y gastric bypass plus medical therapy or medical therapy alone. The primary end point was reduction of ≥30% of the total number of antihypertensive medications while maintaining systolic and diastolic blood pressure <140 mm Hg and 90 mm Hg, respectively, at 12 months. RESULTS: We included 100 patients (70% female, mean age 43.8±9.2 years, mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up. Reduction of ≥30% of the total number of antihypertensive medications while maintaining controlled blood pressure occurred in 41 of 49 patients from the gastric bypass group (83.7%) compared with 6 of 47 patients (12.8%) from the control group with a rate ratio of 6.6 (95% confidence interval, 3.1-14.0; P<0.001). Remission of hypertension was present in 25 of 49 (51%) and 22 of 48 (45.8%) patients randomized to gastric bypass, considering office and 24-hour ambulatory blood pressure monitoring, respectively, whereas no patient submitted to medical therapy was free of antihypertensive drugs at 12 months. A post hoc analysis for the primary end point considering the SPRINT (Systolic Blood Pressure Intervention Trial) target reached consistent results, with a rate ratio of 3.8 (95% confidence interval, 1.4-10.6; P=0.005). Eleven patients (22.4%) from the gastric bypass group and none in the control group were able to achieve SPRINT levels without antihypertensives. Waist circumference, body mass index, fasting plasma glucose, glycohemoglobin, low-density lipoprotein cholesterol, triglycerides, high-sensitivity C-reactive protein, and 10-year Framingham risk score were lower in the gastric bypass than in the control group. CONCLUSIONS: Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01784848.

Microvascular Outcomes after Metabolic Surgery (MOMS) in patients with type 2 diabetes mellitus and class I obesity: rationale and design for a randomised controlled trial.

INTRODUCTION: There are several randomised controlled trials (RCTs) that have already shown that metabolic/bariatric surgery achieves short-term and long-term glycaemic control while there are no level 1A of evidence data regarding the effects of surgery on the microvascular complications of type 2 diabetes mellitus (T2DM). PURPOSE: The aim of this trial is to investigate the long-term efficacy and safety of the Roux-en-Y gastric bypass (RYGB) plus the best medical treatment (BMT) versus the BMT alone to improve microvascular outcomes in patients with T2DM with a body mass index (BMI) of 30-34.9 kg/m2. METHODS AND ANALYSIS: This study design includes a unicentric randomised unblinded controlled trial. 100 patients (BMI from 30 to 34.9 kg/m2) will be randomly allocated to receive either RYGB plus BMT or BMT alone. The primary outcome is the change in the urine albumin-to-creatinine ratio (uACR) captured as the proportion of patients who achieved nephropathy remission (uACR<30 mg/g of albumin/mg of creatinine) in an isolated urine sample over 12, 24 and 60 months. ETHICS AND DISSEMINATION: The study was approved by the local Institutional Review Board. This study represents the first RCT comparing RYGB plus BMT versus BMT alone for patients with T2DM with a BMI below 35 kg/m2. TRIAL REGISTRATION NUMBER: NCT01821508; Pre-results.

The Role of Metabolic Surgery on Blood Pressure Control.

Obesity and hypertension are growing epidemics in the modern world. Lifestyle changes and medical treatment for obesity have disappointing long-term results and albeit drugs for hypertension are usually very effective, the necessity of multiple pills and frequent side effects make the adherence to treatment a huge challenge for healthcare systems. Bariatric/metabolic surgery is a very effective treatment and an exponential number of studies have been showing its positive impact beyond weight loss, mainly on type 2 diabetes. There is also growing evidence suggesting that bariatric/metabolic surgery is associated with reduced incidence of cardiovascular events, but the impact on hypertension and other components of metabolic syndrome usually derive from trials' secondary end points. Taking this limitation in mind, bariatric/metabolic surgery action on blood pressure is reaching a significant proportion of hypertension resolution or improvement. In this review, we discussed the current evidence on the impact of bariatric/metabolic surgery on blood pressure control and pointed out perspectives in this research area.

Effects of gastric bypass surgery in patients with hypertension: rationale and design for a randomised controlled trial (GATEWAY study).

INTRODUCTION: Obesity and overweight are becoming progressively more prevalent worldwide and are independently associated with a significant increase in the risk of cardiovascular diseases. Systemic arterial hypertension is frequently found in association with obesity and contributes significantly to increased cardiovascular risk. We hypothesise that Roux-en-Y gastric bypass (RYGB) surgery, a procedure that effectively reduces body weight, can also positively impact blood pressure control in obese and hypertensive individuals. METHODS AND ANALYSIS: A unicentric, randomised, controlled, unblinded clinical trial. Sixty obese (body mass index between 30 and 39.9) and moderately well controlled hypertensive patients, in use of at least two antihypertensive medications at maximum doses or more than two in moderate doses, will be randomly allocated, using an online, electronic and concealed method, to receive either RYGB plus optimised clinical treatment (OCT) or OCT alone. The primary end point is the reduction of antihypertensive medication at 1 and 2 years of follow-up. Data analysis will primarily be conducted on an intention-to-treat basis. ETHICS AND DISSEMINATION: The study was approved by the local institutional review board that works in total compliance with the latest version of the Helsinki Declaration, the Good Clinical Practices (GCP), the 'America's Document' and the national regulatory laws. Before the beginning of any study-related activities, each study participant is asked to provide a signed informed consent. TRIAL REGISTRATION NUMBER: NCT01784848.

A pilot study of the duodenal-jejunal bypass liner in low body mass index type 2 diabetes.

CONTEXT: The duodenal-jejunal bypass liner (DJBL) is a device that mimics the intestinal portion of gastric bypass surgery and has been shown to improve glucose metabolism rapidly in obese subjects with type 2 diabetes (T2DM). OBJECTIVE: To assess the safety of the DJBL and to evaluate its potential to affect glycemic control beneficially in subjects with T2DM who were not morbidly obese. PATIENTS AND DESIGN: Adult men and women with T2DM of ≤ 10 years' duration with hemoglobin A1c (HbA1c) ≥ 7.5% and ≤ 10% and having a body mass index ≥ 26 to ≤ 50 kg/m(2) were enrolled in this prospective, 52-week, single-center, open-label clinical study. MAIN OUTCOME MEASURES: Adverse events and changes in body weight, fasting plasma glucose (FPG) levels, and HbA1c levels. RESULTS: Sixteen of 20 subjects implanted with the DJBL completed the 1-year study (mean body mass index = 30.0 ± 3.6, mean ± SD). Gastrointestinal disorders were reported by 13 subjects, and metabolic or nutritional disorders occurred in 14 subjects. FPG levels dropped from 207 ± 61 mg/dL at baseline to 139 ± 37 mg/dL at 1 week and remained low throughout the study. Mean body weight also declined, but the change in body weight was not significantly associated with change in FPG at 52 weeks. HbA1c declined from 8.7 ± 0.9% at baseline to 7.5 ± 1.6% at week 52. CONCLUSIONS: The improvements in glycemic status were observed at 1 year in moderately obese subjects with T2DM, suggesting that the DJBL may represent an effective adjuvant to standard medical therapy of T2DM in this population.

Glycemic control after stomach-sparing duodenal-jejunal bypass surgery in diabetic patients with low body mass index.

BACKGROUND: Bariatric surgery frequently results in the resolution of type 2 diabetes mellitus (T2DM). One of the many factors that could explain such findings is the duodenal exclusion of the alimentary tract. To test this hypothesis, a surgical model that induces glycemic control without significant weight loss would be ideal. In the present study, we evaluated the early metabolic changes that occur in overweight diabetic patients after laparoscopic duodenal-jejunal bypass (DJB) and determined the factors associated with success in T2DM resolution. The setting was a private practice. METHODS: A total of 35 patients (20 men and 15 women) were included in the present study. The mean preoperative body mass index was 28.4 ± 2.9 kg/m(2). DJB was performed in all patients, and the anthropometric data and blood samples were collected at baseline (preoperatively) and 3, 6, 9, and 12 months after surgery. Success was defined when patients reached a glycated hemoglobin level of <7% without diabetic medication. RESULTS: T2DM remission was observed in 14 (40%) of 35 patients. No differences in the homeostasis model assessment insulin resistance index levels and patient weight were observed before and 12 months after DJB surgery. Gender, duration of T2DM, previous use of insulin, preoperative homeostasis model assessment insulin resistance index, and C-peptide levels were not significant predictive factors of success or nonsuccess. The only factor that significantly predicted postoperative positive outcomes was a waist circumference reduction of ≥ 7% compared with baseline within the first 6 months after surgery. CONCLUSION: DJB improves glycemic control; however, it does not increase insulin sensitivity in overweight diabetic patients. These changes were observed without significant weight loss.

Laparoscopia e cirurgia bariátrica / Laparoscopy and bariatric surgery

O ganho de popularidade da cirurgia bariátrica recentemente se deve,ao menos parcialmente, ao uso da videolaparoscopia. As cirurgiasbariátricas por videolaparoscopia têm diversas vantagens sobre aquelasoconvencionais. Dentre elas incluem-se a menor resposta aotrauma cirúrgico, menor intensidade de dor e mais rápida volta às atividades físicas e diárias. Associa-se a essas vantagens os benefícios clínicos do tratamento eficaz da obesidade. Esse trabalho resume as vantagens fisiológicas e os excelentes resultados descritos na literatura, reforçando o impacto positivo do acesso videolaparoscópico para o tratamento da obesidade mórbida.

Laparoscopic bariatric surgery: new technologies, trends and perspectives.

Obesity is an endemic disease. It was already proved that the clinical approach to morbid obesity fails in 95% of cases. Laparoscopy has shown that is related to a milder metabolic response and a smoother postoperative period. There is no doubt that the laparoscopic approach is not the future for the surgical treatment of morbid obesity, but the best present approach and with equally excellent results when compared to the traditional open operation. However, this challenging surgery requires masterful use of an array of specialized laparoscopic equipment and instrumentation. These include proper video monitors, cameras, visualization, peritoneal entrance, scopes, cutting/coagulation equipments, and staplers, suturing devices, graspers, dedicated endosurgery operating rooms, robotics and awareness of newer equipment. This paper covers the benefits of the laparoscopic access in bariatric surgery and reviews the cutting-edge in technology to drive surgeons and patients to a smoother intra and postoperative course.

Laparoscopic bariatric surgery: new technologies, trends and perspectives

Obesidade hoje é uma doença endêmica. Está comprovado que o tratamento clínico falha em 95% dos casos. A Cirurgia Laparoscópica já demonstrou ser menos agressiva do ponto de vista sistêmico e metabólico, levando a um pós-operatório mais confortável. Hoje, não existe dúvida que o acesso laparoscópico não é o futuro, mas sim o presente para o tratamento operatório da obesidade mórbida, tendo, pelo menos, os excelentes resultados em termos de perda ponderal e cura das co morbidades quando comparada às operações abertas. Porém, essas operações, por vezes, necessitam de um grande aparato tecnológico, como videocâmeras, monitores de alta resolução, laparoscópios, equipamentos para corte e coagulação eficientes e seguros e até mesmo salas cirúrgicas devotadas às operações minimamente invasivas. Esse artigo discorre sobre os benefícios do acesso laparoscópico, assim como revisa a tecnologia de ponta que pode ser utilizada pela equipe cirúrgica para a condução segura, rápida e eficiente das operações bariátricas por videolaparoscopia.

Videolaparoscopia em ratos: um novo modelo experimental / Videolaparoscopy in rats: a new experimental model

A introdução da videolaparoscopia e sua progressiva aplicação em procedimentos mais complexos e extensos fez surgir a necessidade do desenvolvimento de modelos experimentais tanto para treinamento de novos cirurgiões quanto para desenvolvimento de estudos experimentais. Inicialmente foram usados animais de grande porte, mas a dificuldade no manuseio e o alto custo destes animais levaram à utilização de animais de menor porte. Nosso estudo inova ao demonstrar um modo de utilização de cinco animais de pequeno porte (ratos) ao mesmo tempo conectados em série utilizando apenas um sistema de insuflação peritoneal

Diagnóstico Laparoscópico do abdome agudo na infância / Laparoscopic diagnosis of the acute abdomen in the childhood

Os autores apresentam estudo prospectivo do emprego de laparoscopia diagnóstica de urgência em 17 crianças com idades entre quatro e 12 anos que, após exames clínicos e laboratoriais iniciais, permaneceram com suspeita de comprometimento visceral intraperitoneal. Entre as crianças estudadas, 14 eram vítimas de traumatismo abdominal (13 traumas fechados e um penetrante) e três tinham suspeita de abdome agudo inflamatório. Recomenda-se o uso sistemático da anestesia geral. A técnica empregada foi a mesma usaada em casos eletivos. A laparoscopia revelou acurácia de 94 por cento, sensibilidade de 93 por cento, especificidade de 100 por cento, valor preditivo positivo de 100 por cento e valor preditivo negativo de 67 por cento, sem ter apresentado nenhuma complicaçao. O método mostrou-se eficaz para excluir intervençoes desnecessárias, o que ocorreu em 76 por cento das crianças estudadas. A laparoscopia mostrou-se capaz de orientar adequada e precocemente a melhor conduta terapêutica a ser adotada em cada caso e está sempre indicada nos casos em que haja dúvida quanto ao diagnóstico e conduta.

Cuidados operatórios em feocromocitoma: apresentaçäo de um caso / Preoperative preparation in pheochromocytoma: a case report

Os autores apresentam um caso de paciente com feocromocitoma, interna no hospital com diagnóstico de síndrome hipertensiva e tumor de supra-renal, abordando aspectos dos exames laboratoriais e de imagem, do preparo operatório e do tratamento cirúrgico. Uma discusäo atual é apresentada sobre estes aspectos, ressaltando a importância do plano cirúrgico em tumor grande como o do presente caso; além de um resumo sobre os critérios atuais de determinaçäo de malignidade do feocromocitoma e seu prognóstico a longo prazo

Alteraçöes mecânicas de fêmures de ratos submetidos a métodos de conservaçäo / Mechanical changes of rat femurs subjected to conservation methods

Foram testados 47 pares de fêmures de rato quanto à sua resistência à flexäo e deformaçäo. Em todos os casos um dos elementos do par era testado imediatamente após o sacrifício (grupo de controle). Dos elementos opostos, 15 fêmures foram expostos ao meio ambiente, 15 fêmures conservados em formol a 10% e 17 fêmures congelados a - 20%C, por período de 15 dias. No primeiro grupo, a resistência à flexäo diminuiu e a rigidez aumentou; no segundo, diminuiu a rigidez sem alterar a resistência e, no terceiro grupo, näo houve alteraçöes significativas