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Association of prior metabolic and bariatric surgery with severity of coronavirus disease 2019 (COVID-19) in patients with obesity.
Aminian, A, Fathalizadeh, A, Tu, C, Butsch, WS, Pantalone, KM, Griebeler, ML, Kashyap, SR, Rosenthal, RJ, Burguera, B, Nissen, SE
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2021;17(1):208-214
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A growing body of evidence indicates that patients with obesity are disproportionately affected with a severe form of SARS-CoV-2 infection and may experience resultant higher mortality. The aim of this study was to determine the association of prior metabolic surgery with severity of SARSCoV-2 infection in patients with severe obesity. This study is a retrospective, matched-cohort analysis of a prospective, observational, institutional review board–approved clinical registry of all patients tested for SARS-CoV-2 infection. The study population included a total of 363 patients, including 33 individuals who had metabolic surgery and 330 matched patients who tested positive. Results indicate that a history of metabolic surgery is associated with lower severity of SARSCoV-2 infection in patients with severe obesity, as manifested by lower risks of hospital and ICU admission. Authors conclude that prior metabolic surgery with subsequent weight loss and improvement of metabolic abnormalities could potentially reduce morbidity from SARS-CoV-2 infection.
Abstract
BACKGROUND Obesity is a risk factor for poor clinical outcomes in patients with coronavirus disease 2019 (COVID-19). OBJECTIVES To investigate the relationship between prior metabolic surgery and the severity of COVID-19 in patients with severe obesity. SETTING Cleveland Clinic Health System in the United States. METHODS Among 4365 patients who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) between March 8, 2020 and July 22, 2020 in the Cleveland Clinic Health System, 33 patients were identified who had a prior history of metabolic surgery. The surgical patients were propensity matched 1:10 to nonsurgical patients to assemble a cohort of control patients (n = 330) with a body mass index (BMI) ≥ 40 kg/m2 at the time of SARS-CoV-2 testing. The primary endpoint was the rate of hospital admission. The exploratory endpoints included admission to the intensive care unit (ICU), need for mechanical ventilation and dialysis during index hospitalization, and mortality. After propensity score matching, outcomes were compared in univariate and multivariate regression models. RESULTS The average BMI of the surgical group was 49.1 ± 8.8 kg/m2 before metabolic surgery and was down to 37.2 ± 7.1 at the time of SARS-CoV-2 testing, compared with the control group's BMI of 46.7 ± 6.4 kg/m2. In the univariate analysis, 6 (18.2%) patients in the metabolic surgery group and 139 (42.1%) patients in the control group were admitted to the hospital (P = .013). In the multivariate analysis, a prior history of metabolic surgery was associated with a lower hospital admission rate compared with control patients with obesity (odds ratio, 0.31; 95% confidence interval, 0.11-0.88; P = .028). While none of the 4 exploratory outcomes occurred in the metabolic surgery group, 43 (13.0%) patients in the control group required ICU admission (P = .021), 22 (6.7%) required mechanical ventilation, 5 (1.5%) required dialysis, and 8 (2.4%) patients died. CONCLUSION Prior metabolic surgery with subsequent weight loss and improvement of metabolic abnormalities was associated with lower rates of hospital and ICU admission in patients with obesity who became infected with SARS-CoV-2. Confirmation of these findings will require larger studies.
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Lipids activate skeletal muscle mitochondrial fission and quality control networks to induce insulin resistance in humans.
Axelrod, CL, Fealy, CE, Erickson, ML, Davuluri, G, Fujioka, H, Dantas, WS, Huang, E, Pergola, K, Mey, JT, King, WT, et al
Metabolism: clinical and experimental. 2021;121:154803
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Insulin resistance is a key pathophysiological mechanism in the development and progression of type 2 diabetes. Abnormalities in lipid metabolism and ectopic lipid accumulation are known to directly contribute to the onset of insulin resistance. Authors hypothesised that lipid infusion would increase dynamin related protein 1 [a type of protein]-mediated mitochondrial fission in skeletal muscle independent of function and content, consequently reducing peripheral insulin sensitivity. The study included sedentary but otherwise healthy adults who were prospectively randomized to receive either lipid or saline infusion to isolate the direct contribution of fatty acids to skeletal muscle mitochondrial dynamics. Results show that mitochondrial fission and quality control networks are activated in response to lipid infusion which occurs independent of changes in mitochondrial content or capacity and contributes to the onset of insulin resistance in healthy humans. Authors conclude that treatments that limit lipid-induced activation of mitochondrial fission and/or quality control processes may have therapeutic value in the treatment of insulin resistance.
Abstract
BACKGROUND AND AIMS A diminution in skeletal muscle mitochondrial function due to ectopic lipid accumulation and excess nutrient intake is thought to contribute to insulin resistance and the development of type 2 diabetes. However, the functional integrity of mitochondria in insulin-resistant skeletal muscle remains highly controversial. METHODS 19 healthy adults (age:28.4 ± 1.7 years; BMI:22.7 ± 0.3 kg/m2) received an overnight intravenous infusion of lipid (20% Intralipid) or saline followed by a hyperinsulinemic-euglycemic clamp to assess insulin sensitivity using a randomized crossover design. Skeletal muscle biopsies were obtained after the overnight lipid infusion to evaluate activation of mitochondrial dynamics proteins, ex-vivo mitochondrial membrane potential, ex-vivo oxidative phosphorylation and electron transfer capacity, and mitochondrial ultrastructure. RESULTS Overnight lipid infusion increased dynamin related protein 1 (DRP1) phosphorylation at serine 616 and PTEN-induced kinase 1 (PINK1) expression (P = 0.003 and P = 0.008, respectively) in skeletal muscle while reducing mitochondrial membrane potential (P = 0.042). The lipid infusion also increased mitochondrial-associated lipid droplet formation (P = 0.011), the number of dilated cristae, and the presence of autophagic vesicles without altering mitochondrial number or respiratory capacity. Additionally, lipid infusion suppressed peripheral glucose disposal (P = 0.004) and hepatic insulin sensitivity (P = 0.014). CONCLUSIONS These findings indicate that activation of mitochondrial fission and quality control occur early in the onset of insulin resistance in human skeletal muscle. Targeting mitochondrial dynamics and quality control represents a promising new pharmacological approach for treating insulin resistance and type 2 diabetes. CLINICAL TRIAL REGISTRATION NCT02697201, ClinicalTrials.gov.
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Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial.
Pantalone, KM, Smolarz, BG, Ramasamy, A, Baz Hecht, M, Harty, BJ, Rogen, B, Griebeler, ML, Borukh, E, Young, JB, Burguera, B
JAMA network open. 2021;(7):e2116595
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Abstract
IMPORTANCE The clinical efficacy of antiobesity medications (AOMs) as adjuncts to lifestyle intervention is well characterized, but data regarding their use in conjunction with workplace wellness plans are lacking, and coverage of AOMs by US private employers is limited. OBJECTIVE To determine the effect of combining AOMs with a comprehensive, interdisciplinary, employer-based weight management program (WMP) compared with the WMP alone on weight loss, treatment adherence, and work productivity and limitations. DESIGN, SETTING, AND PARTICIPANTS This 1-year, single-center, open-label, parallel-group, real-world, randomized clinical trial was conducted at the Cleveland Clinic's Endocrinology and Metabolism Institute in Cleveland, Ohio, from January 7, 2019, to May 22, 2020. Participants were adults with obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] ≥30) enrolled in the Cleveland Clinic Employee Health Plan. INTERVENTIONS In total, 200 participants were randomized 1:1, 100 participants to WMP combined with an AOM (WMP+Rx), and 100 participants to WMP alone. The WMP was the Cleveland Clinic Endocrinology and Metabolism Institute's employer-based integrated medical WMP implemented through monthly multidisciplinary shared medical appointments. Participants in the WMP+Rx group initiated treatment with 1 of 5 US Food and Drug Administration-approved medications for chronic weight management (orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, and liraglutide, 3.0 mg) according to standard clinical practice. MAIN OUTCOMES AND MEASURES The primary end point was the percentage change in body weight from baseline to month 12. RESULTS The 200 participants were predominately (177 of 200 [88.5%]) women, had a mean (SD) age of 50.0 (10.3) years, and a mean (SD) baseline weight of 105.0 (19.0) kg. For the primary intention-to-treat estimand, the estimated mean (SE) weight loss was -7.7% (0.7%) for the WMP+Rx group vs -4.2% (0.7%) for the WMP group, with an estimated treatment difference of -3.5% (95% CI, -5.5% to -1.5%) (P < .001). The estimated percentage of participants achieving at least 5% weight loss was 62.5% for WMP+Rx vs 44.8% for WMP (P = .02). The rate of attendance at shared medical appointments was higher for the WMP+Rx group than for the WMP group. No meaningful differences in patient-reported work productivity or limitation measures were observed. CONCLUSIONS AND RELEVANCE Clinically meaningful superior mean weight loss was achieved when access to AOMs was provided in the real-world setting of an employer-based WMP, compared with the WMP alone. Such results may inform employer decisions regarding AOM coverage and guide best practices for comprehensive, interdisciplinary employer-based WMPs. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03799198.
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Obesity: Are shared medical appointments part of the answer?
Shibuya, K, Pantalone, KM, Burguera, B
Cleveland Clinic journal of medicine. 2018;(9):699-706
Abstract
Shared medical appointments, in which a multidisciplinary team of healthcare providers meets with multiple patients in a group setting, may be an option for treating patients with obesity. To be effective, shared medical appointments need to address patients' nutrition, physical activity, appetite suppression, stress management, and sleep.
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Bariatric Surgery in Obese Patients With Type 1 Diabetes.
Kirwan, JP, Aminian, A, Kashyap, SR, Burguera, B, Brethauer, SA, Schauer, PR
Diabetes care. 2016;(6):941-8
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Abstract
OBJECTIVE There is a paucity of data on the impact of bariatric surgery in type 1 diabetes (T1D). The aim of this review was to quantify the overall effects of bariatric surgery in obese patients with T1D. METHODS We searched PubMed, Scopus, ISI Web of Knowledge, and Google Scholar from their inception to December 2015 to identify all relevant studies of bariatric surgery in adult obese patients with T1D. RESULTS The review included 17 studies with 107 individuals, including 10 case series and 7 case reports. Overall, the dominant procedure was gastric bypass (n = 70; 65%). All studies reported a significant reduction in excess weight. A significant reduction in weight-adjusted daily insulin requirements was shown in all case series except one. Pooled mean ± SD of pre- and postoperative glycated hemoglobin (HbA1c) for the entire cohort with available data (n = 96) was 8.4 ± 1.3% and 7.9 ± 1.1%, respectively (P = 0.01). In addition to common postoperative complications, profound glycemic changes (diabetic ketoacidosis and hypoglycemia) and gastrointestinal dysmotility symptoms (prolonged ileus and acute gastric remnant dilation) have been reported. No surgical mortality was reported. CONCLUSIONS Bariatric surgery leads to significant weight loss in severely obese patients with T1D and results in a significant improvement in insulin requirements and glycemic status. The favorable metabolic effects of bariatric surgery may facilitate medical management of and cardiovascular risk reduction in T1D in the setting of severe obesity. Diabetic ketoacidosis and hypoglycemia are potentially serious complications. Short-term results of bariatric surgery in patients with T1D are encouraging, but larger and longer-term studies are needed.
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Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus.
Goday, A, Bellido, D, Sajoux, I, Crujeiras, AB, Burguera, B, García-Luna, PP, Oleaga, A, Moreno, B, Casanueva, FF
Nutrition & diabetes. 2016;(9):e230
Abstract
UNLABELLED Brackground:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients. OBJECTIVE Evaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional weight loss program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM. METHODS Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m(-)(2) participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional weight loss (VLCK diet), and 44 to the standard low-calorie diet. RESULTS No significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up. CONCLUSIONS The interventional weight loss program based on a VLCK diet is most effective in reducing body weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.
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An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study-A Two-Year Randomized Controlled Clinical Trial.
Burguera, B, Jesús Tur, J, Escudero, AJ, Alos, M, Pagán, A, Cortés, B, González, XF, Soriano, JB
International journal of endocrinology. 2015;:194696
Abstract
Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients. Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients. Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI) (n = 60) or Conventional Obesity Therapy (COT) (n = 46). The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG) (n = 37). Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (-11.3% versus -1.6%; p < 0.0044). Interestingly 31.4% of patients included in the ILI group were no longer morbidly obese after just six months of intervention, increasing to 44.4% after 24 months of intervention. The percentage weight loss in SOG was -29.6% after that same period of time. Conclusions. ILI was associated with significant weight loss when compared to COT, in a group of patients with obesity. An ILI approach could be an alternative therapy to patients with obesity, who are not candidates to undergo bariatric surgery. This trial is registered with EudraCT 2009-013737-24.
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One year weight loss in the TRAMOMTANA study. A randomized controlled trial.
Tur, JJ, Escudero, AJ, Alos, MM, Salinas, R, Terés, E, Soriano, JB, Nicola, G, Urgelés, JR, Pagán, A, Cortes, B, et al
Clinical endocrinology. 2013;(6):791-9
Abstract
BACKGROUND Morbid obesity is a major health problem and bariatric surgery is currently the most effective therapy available to induce weight loss in these patients. This report describes 1-year changes in weight and metabolic parameters, in a trial designed to examine the effects of a nonsurgical approach, Intensive Life style Intervention (ILI) on the therapy of morbid obesity. METHODS The primary outcome was change in body weight. Patients were randomized to ILI (n = 60) or conventional obesity therapy (COT) (n = 46). The ILI group received behavioural therapy and nutritional/physical activity counselling. The COT group received the standard medical treatment available for these patients. A third group consisted of the patients already included in our bariatric surgery waiting list (n = 37). FINDINGS We present here 1-year data showing that patients who received ILI with no restrictions in calorie intake had a greater percentage of weight loss than patients receiving COT (-11·58% vs -0·4%; P < 0·001). Importantly, 31·4% of patients included in the ILI group were not morbidly obese after 6 months of intervention. This number increased to 42·8% after 12 months of intervention. INTERPRETATION ILI was associated with significant weight loss compared with COT in a group of morbidly obese patients. The weight loss effect was already obtained after 6 months of ILI intervention. These results seriously question the efficacy of the COT approach to morbid obesity. Furthermore, they underscore the use of ILI programmes in the hospital setting to effectively treat morbidly obese patients and might help to reduce the number of candidate patients for bariatric surgery.
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Breaking therapeutic inertia: should metabolic surgery be considered one more option for the treatment of type 2 diabetes mellitus?
Lecube, A, Burguera, B, Rubio, MÁ, ,
Endocrinologia y nutricion : organo de la Sociedad Espanola de Endocrinologia y Nutricion. 2012;(5):281-3
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[TRAMOMTANA (Multidisciplinary treatment of morbid obesity: medication, behavioral therapy, nutritional support, and physical activity). From question to reality in an investigator-initiated clinical trial (II)].
Tur, J, Alòs, M, Iglesias, L, Luque, L, Colom, A, Escudero, A, Martínez, D, Pagán, A, Ugarriza, E, Frontera, M, et al
Endocrinologia y nutricion : organo de la Sociedad Espanola de Endocrinologia y Nutricion. 2011;(6):299-307
Abstract
Implementation of an intensive, multidisciplinary weight loss program in patients with morbid obesity is reported. This program is based on behavioral changes, lifestyle intervention, medication, and group therapy sessions. Our objective is to show that the results achieved with this two-year weight loss program will be at least similar to those achieved with bariatric surgery in patients with morbid obesity. We also intend to show that this multidisciplinary treatment induces an improvement in the comorbidity rate associated to smaller costs for our national health system.