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.

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.

Tumor seudopapilar sólido del páncreas / Pseudopapillary solid tumor of pancreas

Los tumores seudopapilares sólidos del páncreas representan del 1 al 2 % de las lesiones neoplásicas del páncreas exocrino. Descritos por primera vez por Frantz, han recibido múltiples denominaciones hasta su clasificación actual por la Organización Mundial de la Salud (OMS). Carecen de un cuadro clínico típico y frecuentemente se diagnostican de manera incidental por estudios de imágenes de sección transversal, en los que se reconocen características clave para su diagnóstico, y se presentan especialmente en mujeres jóvenes y adolescentes. Actualmente, su tratamiento es fundamentalmente quirúrgico, prefiriéndose técnicas conservadoras, con excelentes resultados a largo plazo. Se reporta el caso de una mujer joven con síntomas abdominales inespecíficos, a quien después de tratamientos previos para otras posibles enfermedades, se le practicó una tomografía computarizada de abdomen en la cual se documentó una lesión de características típicas de este tipo de tumor; fue sometida a pancreatectomía distal y esplenectomía laparoscópicas, con confirmación histológica de la neoplasia y sin necesidad de tratamiento adicional posterior

The solid pseudopapillary pancreatic tumors represent 1 to 2% of the neoplastic lesions of the exocrine pancreas. First described by Frantz, they have received multiple denominations until its current WHO classification. Lacking a typical clinical picture, they are often incidentally diagnosed by cross section imaging studies, in which key features are recognized for establishing diagnosis; their presentation occurs predominantly in young women and adolescents. Current management is based on surgical treatment, preferring conservative techniques with excellent long-term results. We report the case of a young woman with nonspecific abdominal symptoms, who after previous treatments for other possible diseases a CT scan of the abdomen showed a lesion with the characteristics of this tumor and a laparoscopic distal pancreatectomy and splenectomy was performed with histological confirmation of this malignancy without requiring additional treatment

Bariatric and metabolic surgery and microvascular complications of type 2 diabetes mellitus.

INTRODUCTION: Metabolic dysregulation is the defining characteristic of type 2 diabetes mellitus (T2DM) and may lead to microvascular complications, specifically retinopathy, nephropathy and neuropathy. Medical treatment and lifestyle interventions targeting risk factors for microvascular complications can yield therapeutic gains, particularly retinopathy and nephropathy. Bariatric/metabolic surgery is superior to the best medical treatment in several randomized controlled trials. Consequently, evidence of the effect of bariatric/metabolic surgery on microvascular complications is now emerging in the literature. METHODS: A search of the recent published evidence base on the effects of bariatric/metabolic surgery on microvascular complications reveals further evidence that supports the efficacy of surgery in preventing the incidence and progression of albuminuria and preserving renal functional decline. DISCUSSION: Data on retinopathy are ambivalent representing the potential in some cases for an influence of reactive hypoglycaemia over the retina but the majority of data emphasize that the metabolic control can halt the progression of the eye disease. A significant gap in the literature remains in relation to the effects of surgery on diabetic neuropathy, although some information sheds a light on the benefits secondary to the surgical metabolic control. CONCLUSION: Overall, although data so far is exciting, there is a pressing need for prospective randomized controlled trials examining long-term microvascular outcomes following bariatric/metabolic surgery in patients with T2DM.

Cirurgia bariátrica e metabólica e complicações microvasculares do diabetes mellitus tipo 2 (DM2) / Bariatric and metabolic surgery and microvascular complications of type 2 diabetes mellitus

ResumoIntrodução:O diabetes mellitus tipo 2 (DM2) é caracterizado por uma desregulação metabólica, originando complicações microvasculares, mais especificamente a retinopatia, nefropatia e a neuropatia. A prevenção e tratamento das complicações são alvo da farmacoterapia, porém, evidências demonstram que a cirurgia bariátrica/metabólica é superior ao melhor tratamento farmacológico, pois apresenta melhor controle da glicemia, hipertensão e dislipidemias.Métodos:Por meio de pesquisa no PubMed, são discutidas as recentes publicações que evidenciam o efeito positivo das intervenções cirúrgicas sobre as complicações microvasculares, como melhora da microalbuminúria e mesmo preservação de função renal.Discussão:Existem evidências de benefício das operações bariátricas/metabólicas sobre a nefropatia diabética. Os dados sobre retinopatia são ainda ambivalentes. Na literatura, há uma diferença significativa no benefício da cirurgia em neuropatia.Conclusão:Apesar de resultados surpreendentes e positivos, para que se estabeleça definitivamente o papel da cirurgia bariátrica/metabólica nas complicações micovasculares do DM2, há a necessidade de novos estudos randomizados controlados e prospectivos.

AbstractIntroduction:Metabolic dysregulation is the defining characteristic of type 2 diabetes mellitus (T2DM) and may lead to microvascular complications, specifically retinopathy, nephropathy and neuropathy. Medical treatment and lifestyle interventions targeting risk factors for microvascular complications can yield therapeutic gains, particularly retinopathy and nephropathy. Bariatric/metabolic surgery is superior to the best medical treatment in several randomized controlled trials. Consequently, evidence of the effect of bariatric/metabolic surgery on microvascular complications is now emerging in the literature.Methods:A search of the recent published evidence base on the effects of bariatric/metabolic surgery on microvascular complications reveals further evidence that supports the efficacy of surgery in preventing the incidence and progression of albuminuria and preserving renal functional decline.Discussion:Data on retinopathy are ambivalent representing the potential in some cases for an influence of reactive hypoglycaemia over the retina but the majority of data emphasize that the metabolic control can halt the progression of the eye disease. A significant gap in the literature remains in relation to the effects of surgery on diabetic neuropathy, although some information sheds a light on the benefits secondary to the surgical metabolic control.Conclusion:Overall, although data so far is exciting, there is a pressing need for prospective randomized controlled trials examining long-term microvascular outcomes following bariatric/metabolic surgery in patients with T2DM.

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.

Morphology and histopathology of Calyptospora sp. (Apicomplexa: Calyptosporidae) in speckled peacock bass, Cichla temensis Humboldt, 1821 (Perciformes: Cichlidae), from the Marajó-Açu River, Marajó Island, Brazil.

Several species of coccidia are protozoan parasites that cause infection in a wide variety of animal groups. Calyptospora is an important genus of protozoan, which infests both freshwater and marine fish. The hepatopancreases of 150 speckled peacock bass captured on Marajó Island, Brazil were studied macro- and microscopically. Oocysts were found in 84 (56%) of the specimens in both the examination of the fresh material by compression and the analysis of histological sections stained with hematoxylin-eosin. Small, circular, homogeneous forms in negative contrast had a mean diameter of 21.2 µm, frequently with pyriform sporocysts, with a mean length of 9.2 µm and width of 3.1 µm, and a thin-walled capsule, were observed in both the hepatic and the pancreatic parenchyma, but were completely devoid of any inflammatory reaction. Calyptospora infections are documented for the first time in the Marajó-Açu River.

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.