Cognitive Effects of Intentional Weight Loss in Elderly Obese Individuals With Mild Cognitive Impairment.

CONTEXT: Obesity in midlife is a risk factor for dementia, but it is unknown if caloric restriction-induced weight loss could prevent cognitive decline and therefore dementia in elderly patients with cognitive impairment. OBJECTIVE: To evaluate the cognitive effect of intentional weight loss in obese elderly patients with mild cognitive impairment (MCI), considering the influence of age, apolipoprotein E (APOE) genotype, physical activity, biochemical markers, and diet. DESIGN: Single-center, prospective controlled trial. SETTING: Academic medical center. PARTICIPANTS: Eighty obese patients with MCI, aged 60 or older (68.1 ± 4.9 y, body mass index [BMI] 35.5 ± 4.4 kg/m(2), 83.7% women, 26.3% APOE allele ϵ4 carriers). INTERVENTION: Random allocation to conventional medical care alone (n = 40) or together with nutritional counselling (n = 40) in group meetings aiming to promote weight loss through caloric restriction for 12 months. OUTCOME MEASUREMENTS: clinical data, body composition, neuropsychological tests (main outcome), serum biomarkers, APOE genotype, physical performance, dietary recalls. RESULTS: Seventy-five patients completed the follow-up. BMI, on average, decreased 1.7 ± 1.8 kg/m(2) (P = .021), and most of the cognitive tests improved, without difference between the groups. In analysis with linear generalized models, the BMI decrease was associated with improvements in verbal memory, verbal fluency, executive function, and global cognition, after adjustment for education, gender, physical activity, and baseline tests. This association was strongest in younger seniors (for memory and fluency) and in APOE allele ϵ4 carriers (for executive function). Changes in homeostasis model assessment-estimated insulin resistance, C-reactive protein, leptin and intake of energy, carbohydrates, and fats were associated with improvement in cognitive tests. CONCLUSIONS: Intentional weight loss through diet was associated with cognitive improvement in patients with MCI.

A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.

BACKGROUND: Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagon-like peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODS: We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTS: At baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P<0.001, with last-observation-carried-forward imputation). A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P<0.001). The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group. CONCLUSIONS: In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control. (Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839 ClinicalTrials.gov number, NCT01272219.).

Associations between a common variant near the MC4R gene and serum triglyceride levels in an obese pediatric cohort.

Polymorphisms near the MC4R gene may be related to an increased risk for obesity, but studies of variations in this gene and its relation to cardiometabolic profiles and food intake are scarce and controversial. The aim of this study is to evaluate the influence of the variants rs12970134 and rs17782313 near the MC4R gene in food intake, binge eating (BE) behavior, anthropometric parameters, body composition, metabolic profile, and cardiometabolic risk factors in obese children and adolescents. This is a cross-sectional study that included obese children and adolescents. We evaluated anthropometric, metabolic parameters and cardiometabolic risk factors, including hypertension, impaired fasting glucose, hypertriglyceridemia, and low HDL-cholesterol. BE was assessed through the BE scale, and a 24-h recall was used to evaluate total caloric intake and percentage of macronutrients and types of dietary fat. The MC4R variants rs12970134 and rs17782313 were genotyped using TaqMan assay. To assess the magnitude of risk, a logistic regression adjusted for Z-BMI, age, and gender was performed, adopting the significance level of 0.05. The study included 518 subjects (52.1 % girls, 12.7 ± 2.7 years old, Z-BMI = 3.24 ± 0.57). Carriers of the variant rs17782313 exhibit increased triglyceride levels (108 ± 48 vs. 119 ± 54, p = 0.034) and an increased risk of hypertriglyceridemia (OR 1.985, 95 % CI 1.288-3.057, p = 0.002). There was no association of the SNP rs12970134 with clinical, metabolic, or nutritional parameters. The variant rs12970134 and rs17782313 did not influence food intake or the presence of BE. The variant rs17782313 is associated with an increased risk of hypertriglyceridemia in obese children and adolescents.

Safety assessment of FDA-approved (orlistat and lorcaserin) anti-obesity medications.

INTRODUCTION: Options for treating obesity remain limited despite it being a chronic, recurrent and morbid condition. New drugs that are proposed for its treatment encounter strong reluctance by regulatory agencies and many doctors. AREAS COVERED: This review will focus on the safety of an older drug, orlistat (the only one still approved in the European Union) and a newer recently FDA-approved one, lorcaserin. Both are approved as long-term monotherapy for obesity in the United States of America and they have demonstrated median weight loss of nearly 3% over placebo. EXPERT OPINION: Research, development and approval of new anti-obesity drugs are necessary for improved management of this chronic condition. Orlistat and lorcaserin are two FDA-approved drugs with limited overall efficacy. Nevertheless they are useful weapons for at least some obese individuals. Orlistat has a long and solid safety profile, whereas the safety of lorcaserin is still a matter of debate, mainly due to a lack of long-term data. However, lorcaserin's selective agonism on 5HT2c serotonin receptors diminishes concerns about valvulopathy associated with other serotonin agonists, such as fenfluramine.

Why are anti-obesity drugs stigmatized?

Obesity is a common and morbid disease, but its treatment remains far from ideal. Many doctors, regulatory agencies, media outlets and patients consider lifestyle modification as the only possible intervention. Pharmacological agents, although with limitations, are useful weapons but are highly stigmatized. Some reasons for this stigma are discussed in this editorial and include: the failure of short-term medication use to achieve long-term results (due to the chronic and recurrent condition of obesity); common perception of obesity as a lifestyle choice; difficulty to treat obesity in the primary care setting; less than desired weight-loss results with medications; misuse of medications for cosmetic reasons; and unfavorable history of other anti-obesity drugs that were withdrawn in previous decades.

Brown adipose tissue: what have we learned since its recent identification in human adults / Tecido adiposo marrom: o que aprendemos desde sua recente identificação em humanos adultos

Brown adipose tissue, an essential organ for thermoregulation in small and hibernating mammals due to its mitochondrial uncoupling capacity, was until recently considered to be present in humans only in newborns. The identification of brown adipose tissue in adult humans since the development and use of positron emission tomography marked with 18-fluorodeoxyglucose (PET-FDG) has raised a series of doubts and questions about its real importance in our metabolism. In this review, we will discuss what we have learnt since its identification in humans as well as both new and old concepts, some of which have been marginalized for decades, such as diet-induced thermogenesis. Arq Bras Endocrinol Metab. 2014;58(9):889-99.

O tecido adiposo marrom, órgão essencial para a termorregulação de animais hibernantes e pequenos devido à sua capacidade desacopladora, era até poucos anos considerado presente apenas em recém-nascidos na espécie humana. A identificação do tecido adiposo marrom em adultos com o desenvolvimento e uso da tomografia de emissão de pósitron marcado com 18-fluorodesoxiglicose (PET-FDG) gerou questões sobre sua real importância para nosso metabolismo. Nesta revisão, discutiremos o que aprendemos nesse tempo, assim como conceitos antigos e novos, alguns marginalizados por décadas, como a termogênese induzida por dieta. Arq Bras Endocrinol Metab. 2014;58(9):889-99.

Changes in neuropsychological tests and brain metabolism after bariatric surgery.

CONTEXT: The mechanisms by which obesity alters the cerebral function and the effect of weight loss on the brain have not been completely clarified. OBJECTIVE: The objective of the study was to assess the effect of bariatric surgery on the cognitive function and cerebral metabolism. DESIGN: Seventeen obese women were studied prior to and 24 weeks after bariatric surgery using neuropsychological tests and positron emission tomography. SETTING: The study was conducted in a reference center for the treatment of obesity of a Brazilian public university. PARTICIPANTS: Thirty-three women paired by age and level of education made up two groups: 17 severely obese patients and 16 lean patients. They did not have diabetes mellitus or a family history of dementia. MAIN OUTCOME MEASURES: Comparison of performance in neuropsychological tests and cerebral metabolism of the obese women before and after bariatric surgery was measured. The results found at the two moments were compared with those of the women of normal weight. RESULTS: Women with a mean age of 40.5 years and mean body mass index of 50.1 kg/m(2) when compared with women with mean body mass index of 22.3 kg/m(2) showed increased cerebral metabolism, especially in the posterior cingulate gyrus (P < .004). No difference was found between the groups for the neuropsychological tests. After 24 weeks the cerebral metabolism of the obese women was lower, similar to the lean women, and there was an improvement of executive function, accompanying changes of metabolic and inflammatory parameters. CONCLUSIONS: Obese women may have increased cerebral metabolism when compared with women of normal weight, and this appears to reverse after weight loss induced by bariatric surgery, accompanied by improved executive function.

Obesidade na mulher / Obesity in the women

Estudos longitudinais sugerem que mulheres têm o dobro do risco que os homens de experimentar grandes ganhos de peso ao longo da vida, o que pode estar associado ao maior sedentarismo entre as mulheres, às gestações, à história familiar de obesidade, ao casamento em idade mais jovem e à cessação de tabagismo. O desenvolvimento de estratégias de tratamento e prevenção efetivas para a obesidade requer um melhor entendimento dos determinantes ambientais, comportamentais, sociodemográficos e genéticos do ganho e da manutenção do peso. É importante destacar que, além de avaliar os fatores preditores de obesidade, torna-se também fundamental examinar quais os fatores associados com a manutenção de um peso saudável, pois estes podem ter um importante papel nas estratégias de intervenções preventivas. O objetivo deste artigo é chamar a atenção para o impacto negativo que a obesidade apresenta na saúde da mulher, enfatizando a necessidade, não só de mudanças individuais dietéticas e de estilo de vida, mas também a necessidade de mudanças nas crenças e práticas dos profissionais de saúde diante da obesidade da mulher, que é uma doença muitas vezes ignorada, subdiagnosticada e mal ou incorretamente tratada. Para isso, daremos uma orientação prática para os clínicos gerais sobre como conduzir a avaliação inicial, diagnosticar e tratar a obesidade na mulher.

Diabetes mellitus / Diabetes mellitus

O diabetes mellitus é uma doença de importantíssimo impacto populacional, tendo em vista sua alta incidência e sua prevalência crescente ao longo dos últimos anos. Tendo em vista que na maioria dos casos o quadro clínico é muito frustro e os pacientes são pouco sintomáticos, o diagnóstico costuma ser feito muito tardiamente, quando muitas complicações micro e macrovasculares já se instalaram. O tratamento inclui educação, normalização da glicemia, avaliação de complicações macrovasculares e microvasculares, assim como redução de fatores de riscos cardiovasculares.

Brown adipose tissue: what have we learned since its recent identification in human adults.

Brown adipose tissue, an essential organ for thermoregulation in small and hibernating mammals due to its mitochondrial uncoupling capacity, was until recently considered to be present in humans only in newborns. The identification of brown adipose tissue in adult humans since the development and use of positron emission tomography marked with 18-fluorodeoxyglucose (PET-FDG) has raised a series of doubts and questions about its real importance in our metabolism. In this review, we will discuss what we have learnt since its identification in humans as well as both new and old concepts, some of which have been marginalized for decades, such as diet-induced thermogenesis.

THE MASTICATORY SYSTEM OF THE OBESE: CLINICAL AND ELECTROMYOGRAPHIC EVALUATION.

UNLABELLED: Masticatory performance is determined not only through the speed of mastication, or by the quantity of food ingested; it also depends on the structures and functional integration of the stomatognathic system (SS). OBJECTIVES: This study investigated differences in the SS and orofacial motricity between obese and normal--weight women. METHOD: A total of 18 obese women, with an average age of 28 ± 7.3 years and an average body mass index (BMI) of 37.4 ± 5.1 Kg/m2, and 18 normal--weight women, with an average age of 26 ± 7.6 years and an average BMI of 20.7 ± 1.8 kg/m2, took part in the study. During the speech therapy evaluation, chewing, the number of chewing strokes, and swallowing were observed. The posture, mobility and tonus of lips and tongue, morphology, mobility and tonus of cheeks were designated as normal or altered. The electrical activity of the anterior temporalis, the masticatory muscle was evaluated for both groups using surface electromyography (EMG), which was expressed in microvolts (pV) and registered as Root Mean Squares. RESULTS: Significant differences were found between the two groups in clinical evaluation. In surface EMG, the obese group showed asymmetry of electrical activity of the anterior temporalis. CONCLUSION: This study suggests that speech therapist investigation of the SS should be combined with interdisciplinary obesity management.

Effects of weight loss on asthma control in obese patients with severe asthma.

Studies on the effects of weight loss in patients with asthma are scarce. No studies have been performed in patients with severe asthma. Therefore, the aim of the present study was to assess the impact of weight loss in patients with severe asthma associated with obesity. This was an open, prospective, randomised study of two parallel groups, in patients with severe uncontrolled asthma and moderate obesity. The primary outcome was the level of asthma control 6 months after initiation of the weight reduction programme, quantified using the Asthma Control Questionnaire (ACQ). We evaluated clinical parameters, lung function, markers of airway inflammation and circulating cytokines. 22 patients were randomised to undergo treatment for obesity and 11 to the control group. The weight reduction programme was associated with significant improvements in asthma control (mean ± se ACQ score 3.02 ± 0.19 to 2.25 ± 0.28 in the treatment group versus 2.91 ± 0.25 to 2.90 ± 0.16 in the controls, p=0.001). This improvement was not accompanied by changes in markers of airway inflammation or bronchial reactivity, but by an increase in forced vital capacity. Our results suggest that weight reduction in obese patients with severe asthma improves asthma outcomes by mechanisms not related to airway inflammation.

Short-term use of liraglutide in the management of patients with weight regain after bariatric surgery.

OBJECTIVE: To evaluate the results of the use of liraglutide in a group of patients undergoing surgical treatment of morbid obesity with unsatisfactory weight loss or regain of more than 15% of minimum reached weight. METHODS: The authors conducted a retrospective analysis of 15 operated patients who had excess weight loss <50% after two years of follow-up or regained weight more than 15% of the minimum reached weight. We included only patients who had the expected "surgical anatomy", assessed by contrast radiography and endoscopy. Mean age was 47.2 ± 12.5 years, and patients received liraglutide at doses from 1.2 to 3.0 mg/day for eight to 28 weeks follow-up. RESULTS: Surgical treatment induced a weight loss of 34.1 ± 16.5 kg. The average weight regain after 5.3 ± 3.3 years was 14.2 ± 12.1 Kg. The average weight was significantly reduced after treatment with liraglutide (100.9 ± 18.3 kg. vs Kg 93.5 ± 17.4, p <0.0001). Six patients had nausea and two discontinued therapy due to the cost of medication. CONCLUSION: medical treatment directed to the control of satiety using liraglutide may be an alternative treatment of patients with poor weight loss or weight regain after surgery when no technical problem has been identified.

Tratamento de curto prazo com liraglutide no reganho de peso após cirurgia bariátrica / Short-term use of liraglutide in the management of patients with weight regain after bariatric surgery

OBJETIVO: avaliar os resultados da utilização do liraglutide em um grupo de pacientes submetidos ao tratamento cirúrgico da obesidade mórbida com perda insatisfatória de peso ou ganho de mais de 15% do seu peso mínimo atingido. MÉTODOS: realizou-se análise retrospectiva de 15 pacientes operados que tiveram perda de excesso de peso <50% após dois anos de seguimento ou reganho de peso de mais de 15% do peso mínimo atingido. Foram incluídos apenas pacientes que apresentavam a "anatomia cirúrgica" normal avaliada por radiografia contrastada e endoscopia digestiva alta. A média de idade foi 47,2±12,5 anos e os pacientes receberam liraglutide na dose de 1,2 a 3,0mg/dia por oito a 28 semanas de seguimento. RESULTADOS: o tratamento cirúrgico induziu uma perda de peso de 34,1± 16,5Kg. A média de reganho de peso após 5,3 ±3,3 anos foi 14,2±12,1Kg. A media de peso reduziu significativamente após o tratamento com liraglutide (100,9±18,3Kg vs. 93,5±17,4Kg; p<0,0001). Seis pacientes apresentaram náuseas e dois descontinuaram o tratamento em decorrência do custo da medicação. CONCLUSÃO: o tratamento clínico medicamentoso dirigido para o controle da saciedade com o uso do liraglutide pode ser uma alternativa para manejo dos pacientes com reganho de peso ou perda insuficiente após o tratamento cirúrgico, quando nenhum problema técnico tenha sido identificado.

OBJECTIVE: To evaluate the results of the use of liraglutide in a group of patients undergoing surgical treatment of morbid obesity with unsatisfactory weight loss or regain of more than 15% of minimum reached weight. METHODS: The authors conducted a retrospective analysis of 15 operated patients who had excess weight loss <50% after two years of follow-up or regained weight more than 15% of the minimum reached weight. We included only patients who had the expected "surgical anatomy", assessed by contrast radiography and endoscopy. Mean age was 47.2 ± 12.5 years, and patients received liraglutide at doses from 1.2 to 3.0 mg/day for eight to 28 weeks follow-up. RESULTS: Surgical treatment induced a weight loss of 34.1 ± 16.5 kg. The average weight regain after 5.3 ± 3.3 years was 14.2 ± 12.1 Kg. The average weight was significantly reduced after treatment with liraglutide (100.9 ± 18.3 kg. vs Kg 93.5 ± 17.4, p <0.0001). Six patients had nausea and two discontinued therapy due to the cost of medication. CONCLUSION: medical treatment directed to the control of satiety using liraglutide may be an alternative treatment of patients with poor weight loss or weight regain after surgery when no technical problem has been identified.

Fixed-dose combination of phentermine-topiramate for the treatment of obesity.

The aim of this article is to focus on the fixed-dose combination of phentermine and topiramate, a new antiobesity drug recently approved by the US FDA. The mechanisms of weight loss for each drug in monotherapy is described, followed by the rationale for its use as a combination therapy and a comprehensive review of recently published clinical trials that assessed its efficacy  and safety.

Lack of mutations in the leptin receptor gene in severely obese children.

OBJECTIVE: To analyze the LEPR gene in obese children and to investigate the associations between molecular findings and anthropometric and metabolic features. SUBJECTS AND METHODS: Thirty-two patients were evaluated regarding anthropometric characteristics, blood pressure, heart rate, serum glucose, insulin, leptin levels, and lipid profile. The molecular study consisted of the amplification and automatic sequencing of the coding region of LEPR in order to investigate new mutations. RESULTS: We identified a high prevalence of metabolic disorders: impaired fasting glucose in 12.5% of the patients, elevated HOMA-IR in 85.7%, low HDL-cholesterol levels in 46.9%, high triglyceride levels in 40.6%, and hypertension in 58.6% of the patients. The molecular study identified 6 already described allelic variants: rs1137100 (exon-2), rs1137101 (exon-4), rs1805134 (exon-7), rs8179183 (exon-12), rs1805096 (exon-18), and the deletion/insertion of the pentanucleotide CTTTA at 3'untranslated region. CONCLUSIONS: The frequency of alleles observed in this cohort is similar to that described in the literature, and was not correlated with any clinical feature. The molecular findings in the analysis of the LEPR did not seem to be implicated in the etiology of obesity in these patients.

Lack of mutations in the leptin receptor gene in severely obese children / Ausência de mutação no gene receptor de leptina em crianças gravemente obesas

OBJECTIVE: To analyze the LEPR gene in obese children and to investigate the associations between molecular findings and anthropometric and metabolic features. SUBJECTS AND METHODS: Thirty-two patients were evaluated regarding anthropometric characteristics, blood pressure, heart rate, serum glucose, insulin, leptin levels, and lipid profile. The molecular study consisted of the amplification and automatic sequencing of the coding region of LEPR in order to investigate new mutations. RESULTS: We identified a high prevalence of metabolic disorders: impaired fasting glucose in 12.5% of the patients, elevated HOMA-IR in 85.7%, low HDL-cholesterol levels in 46.9%, high triglyceride levels in 40.6%, and hypertension in 58.6% of the patients. The molecular study identified 6 already described allelic variants: rs1137100 (exon-2), rs1137101 (exon-4), rs1805134 (exon-7), rs8179183 (exon-12), rs1805096 (exon-18), and the deletion/insertion of the pentanucleotide CTTTA at 3'untranslated region. CONCLUSIONS: The frequency of alleles observed in this cohort is similar to that described in the literature, and was not correlated with any clinical feature. The molecular findings in the analysis of the LEPR did not seem to be implicated in the etiology of obesity in these patients.

OBJETIVO: Analisar o LEPR em crianças obesas e investigar associações entre achados moleculares e características antropométricas e metabólicas. SUJEITOS E MÉTODOS: Foram avaliados 32 pacientes quanto às características antropométricas, à pressão arterial, à frequência cardíaca, às dosagens séricas de glicemia, à insulina, à leptina e ao perfil lipídico. O estudo molecular consistiu na amplificação e no sequenciamento automático da região codificadora do LEPR para pesquisar mutações. RESULTADOS: Identificou-se uma alta prevalência de distúrbios metabólicos: glicemia de jejum alterada em 12,5%, HOMA-IR elevado em 85,7%, níveis de HDL-colesterol baixos em 46,9%, níveis de triglicérides elevados em 40,6% e hipertensão arterial em 58,6%. O estudo molecular identificou 6 variações alélicas já descritas na literatura: rs1137100 (éxon-2), rs1137101 (éxon-4), rs1805134 (éxon-7), rs8179183 (éxon-12), rs1805096 (éxon-18) e deleção/inserção do pentanucleotídeo CTTTA na região 3' não traduzida. CONCLUSÕES: A frequência das variações alélicas observada é semelhante à descrita na literatura e não se correlacionou com nenhuma característica clínica. Os resultados da análise molecular do LEPR não parecem estar implicados na etiologia da obesidade desses pacientes.

Surgical treatment of type 2 diabetes in patients with BMI below 35: mid-term outcomes of the laparoscopic ileal interposition associated with a sleeve gastrectomy in 202 consecutive cases.

BACKGROUND: The objective of this study was to evaluate the mid-term outcomes of the laparoscopic ileal interposition into the jejunum (JII-SG) or into the duodenum (DII-SG) associated with sleeve gastrectomy for type 2 diabetes mellitus (T2DM) patients with BMI below 35. METHODS: The procedures were performed on 202 consecutive patients. Mean age was 52.2 ± 7.5. Mean duration of T2DM was 9.8 ± 5.2 years. Insulin therapy was used by 41.1%. Dyslipidemia was observed in 78.2%, hypertension in 67.3%, nephropathy in 49.5%, retinopathy in 31.2%, coronary heart disease in 11.9%, and other cardiovascular events in 12.9%. RESULTS: Mean follow-up was 39.1 months (range, 25-61). Early and late mortality was 0.99% and 1.0%, respectively. Early reoperation was performed in 2.5%. Early and late major complications were 8.4% and 3.5%. Early most frequent complications were pneumonia and ileus. Intestinal obstruction was diagnosed in 1.5%. Mean BMI decreased from 29.7 to 23.5 kg/m(2), mean fasting glucose from 202.1 to 112.2 mg/dl, and mean postprandial glucose from 263.3 to 130 mg/dl. Triglycerides diminished from a mean of 273.4 to 110.3 mg/dl and cholesterol from a mean of 204.7 to 160.1 mg/dl. Hypertension was resolved in 87.5%. Mean hemoglobin A(1c) (HbA(1c)) decreased from 8.7 to 6.2% after the JII-SG and to 5.9% following the DII-SG. HbA(1c) below 7% was seen in 89.9% of the patients and below 6.5% in 78.3%. Overall, 86.4% of patients were off antidiabetic medications. CONCLUSION: Both JII-SG and DII-SG demonstrated to be safe, effective, and long-lasting alternatives for the treatment of T2DM patients with BMI <35. Beyond glycemic control, other benefits were achieved.

Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner.

BACKGROUND: The purpose of this study was to evaluate the effect of the duodenal-jejunal bypass liner (DJBL), a 60-cm, impermeable fluoropolymer liner anchored in the duodenum to create a duodenal-jejunal bypass, on metabolic parameters in obese subjects with type 2 diabetes. METHODS: Twenty-two subjects (mean age, 46.2±10.5 years) with type 2 diabetes and a body mass index between 40 and 60 kg/m(2) (mean body mass index, 44.8±7.4 kg/m(2)) were enrolled in this 52-week, prospective, open-label clinical trial. Endoscopic device implantation was performed with the patient under general anesthesia, and the subjects were examined periodically during the next 52 weeks. Primary end points included changes in fasting blood glucose and insulin levels and changes in hemoglobin A1c (HbA1c). The DJBL was removed endoscopically at the end of the study. RESULTS: Thirteen subjects completed the 52-week study, and the mean duration of the implant period for all subjects was 41.9±3.2 weeks. Reasons for early removal of the device included device migration (n=3), gastrointestinal bleeding (n=1), abdominal pain (n=2), principal investigator request (n=2), and discovery of an unrelated malignancy (n=1). Using last observation carried forward, statistically significant reductions in fasting blood glucose (-30.3±10.2 mg/dL), fasting insulin (-7.3±2.6 µU/mL), and HbA1c (-2.1±0.3%) were observed. At the end of the study, 16 of the 22 subjects had an HbA1c<7% compared with only one of 22 at baseline. Upper abdominal pain (n=11), back pain (n=5), nausea (n=7), and vomiting (n=7) were the most common device-related adverse events. CONCLUSIONS: The DJBL improves glycemic status in obese subjects with diabetes and therefore represents a nonsurgical, reversible alternative to bariatric surgery.