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1.
Obes Surg ; 33(5): 1401-1410, 2023 05.
Article in English | MEDLINE | ID: mdl-36943608

ABSTRACT

BACKGROUND: Bariatric surgery (BS) is a very effective treatment regarding body weight loss but might affect food tolerance and energy and protein intake. The aim of this study was to compare three BS techniques (biliopancreactic diversion (BPD), gastric bypass (GB), and sleeve gastrectomy (SG)) and their effect on food tolerance. METHODS: Prospective study conducted between April 2016 and April 2019. Visits included were 1 before and 6, 12, and 24 months after BS. Food tolerance test (FTT), 24-h recall, and bioelectrical impedance (TANITA MC780) were performed at all visits. RESULTS: Sixty-six patients were included (74.2% women). FTT showed a better self-perception of the intake after surgery in BPD at 6 months (p = 0.013), and at 12 months (p = 0.006). BPD had a better tolerance of 8 food groups at 6 months (red meat p = 0.017, white meat p = 0.026, salad p = 0.017, bread p < 0.001, rice p = 0.047, pasta p = 0.014, fish p = 0.027) and at 12 months, but only red meat (p = 0.002), bread (p < 0.001), rice (p = 0.025), and pasta (p = 0.025) remained statistically different. Twenty-four months after surgery, only the red meat food group (p = 0.007) showed differences. BPD had the lowest incidence of vomiting at 6 months (p < 0.001), 12 months (p = 0.008), and 24 months (p = 0.002). The total score of FTT was better in BPD at 6 months [25.6 (SD 1.5), p < 0.001], 12 months [25.6 (SD 2.4), p < 0.001], and 24 months [25.7 (SD 1.3), p = 0.001]. BPD showed the best intake in energy and proteins at 6 months [1214.8 (SD 342.4) kcal and 67.1 (SD 18.4) g] and 12 months [1199.6 (SD 289.7) kcal and 73.5 (SD 24.3) g]. % FML was higher in GB both at 6 and 12 months being statistically different (p < 0.050). CONCLUSION: Biliopancreatic diversion appears to be the technique with a better food tolerance and protein and energy intake in the first year of follow-up after BS.


Subject(s)
Bariatric Surgery , Biliopancreatic Diversion , Gastric Bypass , Obesity, Morbid , Female , Male , Humans , Obesity, Morbid/surgery , Prospective Studies , Bariatric Surgery/methods , Gastric Bypass/methods , Biliopancreatic Diversion/methods , Gastrectomy/methods
2.
Nutr. hosp ; 40(1): 67-77, ene.-feb. 2023. tab
Article in Spanish | IBECS | ID: ibc-215689

ABSTRACT

Introducción y objetivos: la baja masa muscular (BMM) condiciona el estado nutricional de un individuo y tiene implicaciones en la calidad y el pronóstico de vida. El objetivo de este trabajo fue evaluar la composición corporal y determinar los valores de normalidad en el diagnóstico de BMM en un grupo de control de individuos sanos. Material y método: estudio transversal de voluntarios sanos con edades entre 18 y 45 años, con un índice de masa corporal (IMC) < 30 kg/m2. Se realizó un estudio descriptivo incluyendo variables demográficas, clínicas, antropométricas y de composición corporal (mediante bioimpedancia, TANITA MC 780 MA; TANITA, Tokio, Japón), con estratificación por edad, sexo e IMC. Se determinaron los valores correspondientes a -1/-2 desviaciones estándar (DE) para considerar una baja masa/función muscular. Resultados: se incluyeron 67 pacientes, el 71,60 % mujeres, con una mediana de edad de 28,29 (RIC: 4,05) años. Los varones presentan mayor peso, IMC, masa libre de grasa (MLG), masa muscular (MM), masa muscular apendicular (MMA), índice de masa muscular apendicular (IMMA) y dinamometría con respecto a las mujeres. Se determinaron los valores de -1/-2 DE de los distintos parámetros musculares en función del sexo. Conclusiones: este estudio determina los valores normales de BMM en una población sana y joven de nuestro medio, y los índices más empleados para expresarla, lo que permitirá diagnosticar la BMM en situaciones patológicas empleando el valor correspondiente a -2 DE. (AU)


Background and aims: low muscle mass (LMM) conditions the nutritional status of an individual and has implications for quality of life and prognosis. The aim of this study was to evaluate body composition and determine normal values in the diagnosis of LMM in a control group of healthy individuals. Methods: a cross-sectional study of healthy volunteers aged 18 to 45 years with body mass index (BMI) < 30 kg/m2, from January 2021 to October 2021. A descriptive study was performed including demographic, clinical, anthropometric, and body composition variables (by bioimpedance, TANITA MC 780 MA; TANITA, Tokyo, Japan), stratified by age, sex and BMI. Values corresponding to -1/-2 standard deviations (SD) were determined to consider low muscle mass/function. Results: we included 67 patients, 71,60 % women, with a median age of 28.29 (IQR 4.05) years. Males presented higher weight, BMI, fat-free mass (FFM), muscle mass (MM), appendicular lean mass (ALM), appendicular lean mass index (ALMI), and dynamometry values when compared to females. The -1/-2 SD values of the various muscle parameters were determined according to sex. Conclusion: this study determined normal LMM values in healthy and young people, and the most commonly used indexes to express it, which will allow the diagnosis of LMM in disease-related situations using the corresponding -2 DS value. (AU)


Subject(s)
Humans , Male , Female , Pregnancy , Young Adult , Adult , Muscles , Muscle Strength , Sarcopenia , Body Mass Index , Epidemiology, Descriptive , Cross-Sectional Studies , Spain , Body Composition
3.
Nutr Hosp ; 40(1): 67-77, 2023 Feb 15.
Article in Spanish | MEDLINE | ID: mdl-36537323

ABSTRACT

Introduction: Background and aims: low muscle mass (LMM) conditions the nutritional status of an individual and has implications for quality of life and prognosis. The aim of this study was to evaluate body composition and determine normal values in the diagnosis of LMM in a control group of healthy individuals. Methods: a cross-sectional study of healthy volunteers aged 18 to 45 years with body mass index (BMI) < 30 kg/m2. A descriptive study was performed including demographic, clinical, anthropometric, and body composition variables (by bioimpedance, TANITA MC 780 MA; TANITA, Tokyo, Japan), stratified by age, sex and BMI. Values corresponding to -1/-2 standard deviations (SD) were determined to consider low muscle mass/function. Results: we included 67 patients, 71,60 % women, with a median age of 28.29 (IQR 4.05) years. Males presented higher weight, BMI, fat-free mass (FFM), muscle mass (MM), appendicular lean mass (ALM), appendicular lean mass index (ALMI), and dynamometry values when compared to females. The -1/-2 SD values of the various muscle parameters were determined according to sex. Conclusion: this study determined normal LMM values in healthy and young people, and the most commonly used indexes to express it, which will allow the diagnosis of LMM in disease-related situations using the corresponding -2 DS value.


Introducción: Introducción y objetivos: la baja masa muscular (BMM) condiciona el estado nutricional de un individuo y tiene implicaciones en la calidad y el pronóstico de vida. El objetivo de este trabajo fue evaluar la composición corporal y determinar los valores de normalidad en el diagnóstico de BMM en un grupo de control de individuos sanos. Material y método: estudio transversal de voluntarios sanos con edades entre 18 y 45 años, con un índice de masa corporal (IMC) < 30 kg/m2. Se realizó un estudio descriptivo incluyendo variables demográficas, clínicas, antropométricas y de composición corporal (mediante bioimpedancia, TANITA MC 780 MA; TANITA, Tokio, Japón), con estratificación por edad, sexo e IMC. Se determinaron los valores correspondientes a -1/-2 desviaciones estándar (DE) para considerar una baja masa/función muscular. Resultados: se incluyeron 67 pacientes, el 71,60 % mujeres, con una mediana de edad de 28,29 (RIC: 4,05) años. Los varones presentan mayor peso, IMC, masa libre de grasa (MLG), masa muscular (MM), masa muscular apendicular (MMA), índice de masa muscular apendicular (IMMA) y dinamometría con respecto a las mujeres. Se determinaron los valores de -1/-2 DE de los distintos parámetros musculares en función del sexo. Conclusiones: este estudio determina los valores normales de BMM en una población sana y joven de nuestro medio, y los índices más empleados para expresarla, lo que permitirá diagnosticar la BMM en situaciones patológicas empleando el valor correspondiente a -2 DE.


Subject(s)
Sarcopenia , Male , Humans , Female , Adolescent , Child, Preschool , Sarcopenia/epidemiology , Cross-Sectional Studies , Quality of Life , Body Mass Index , Muscle, Skeletal/pathology , Body Composition , Absorptiometry, Photon , Muscle Strength
4.
Clin Endocrinol (Oxf) ; 98(5): 730-737, 2023 05.
Article in English | MEDLINE | ID: mdl-36510647

ABSTRACT

INTRODUCTION: COVID-19 has a wide spectrum of clinical severity and there is evidence that SARS-Cov2 affects several organs and systems. Among the organs affected since the beginning of the pandemic, the relationship between SARS-CoV-2 infection and thyroid involvement has been demonstrated. Novel and highly effective messenger RNA and DNA-based vaccines have been rapidly developed to decrease SARS-CoV-2 morbidity and mortality. Early after mass vaccinations, cases of thyroid dysfunction mainly including episodes of subacute thyroiditis, began to be reported like adverse effects. The objective of this study is to determine the impact of the pandemic, both due to SARS-CoV2 infections and vaccinations, on the incidence of Graves' disease (GD). METHODS: Cross-sectional, observational study comparing incidence of GD in adult population (over 18 years) before (2017-2019) and after (2020-2021) Covid-19 pandemic. Only patients with new cases of GD, no relapsed diseases, were included. SARS-CoV-2 diagnosis was based on nucleic acid amplification tests on nasopharyngeal swabs or measurement of class M and class G antibodies to SARS-CoV-2 by highly specific assays. Data on incidence and vaccination related to SARS-CoV-2 infection were obtained from the public records from Castilla y León autonomous regional government. RESULTS: A total of 180 subjects were diagnosed and treated for GD during the study period. We observed a notable increase in expected GD cases in 2021 compared to 2017-19. The number of GD cases was higher in the second (Q2) quarter. Among 2021 GD cases, 42/66 patients (63.6%) had been vaccinated in the 90 days before symptom onset, but none of them in the first quarter of the year. A total of 97.7% were women with a mean age of 48.9 (SD 15.6) years. On average they were diagnosed 19.9 (SD 17.6) days after receiving the vaccine. A total of 7/42 (16.67%) had another previously diagnosed autoimmune disease and 11/42 (26.19%) were smokers. DISCUSSION: Our results show a notable increase in the incidence of GD during the year 2021, specially in women with a history of smoking. Hyper activation of the immune system induced by SARS-CoV2 and by the recently released SARS-COV-2 vaccines has been highlighted in recent months. To assess whether this observed increase in the incidence of GD is sustained in the coming years or has simply been a precipitous trigger for individuals who were already predisposed to develop the disease, future studies will be needed.


Subject(s)
COVID-19 , Graves Disease , Adult , Humans , Female , Middle Aged , Male , Pandemics , RNA, Viral , COVID-19/epidemiology , COVID-19 Testing , COVID-19 Vaccines , Cross-Sectional Studies , Incidence , SARS-CoV-2 , Graves Disease/epidemiology
6.
Nutrition ; 93: 111442, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34482097

ABSTRACT

OBJECTIVE: Obesity is a challenge for bioelectrical impedance analysis (BIA) estimations of skeletal muscle and fat mass (FM), and none of the equations used for appendicular lean mass (ALM) have been developed for people with obesity. By using different equations and proposing a new equation, this study aimed to assess the estimation of FM and ALM using BIA compared with dual-energy x-ray absorptiometry (DXA) as a reference method in a cohort of people with severe obesity. METHODS: This cross-sectional study compared a multifrequency BIA (TANITA MC-780A) versus DXA for body composition assessment in adult patients with severe obesity (body mass index [BMI] of >35 kg/m2). Comparisons between measured (DXA) and predicted (BIA) data for FM and ALM were performed using the original proprietary equations of the device and the equations proposed by Kyle, Sergi, and Yamada. Bland-Altman plots were drawn to evaluate the agreement between DXA and BIA, calculating bias and limits of agreement (LOA). Reliability was analyzed using intraclass correlation coefficient (ICC). Stepwise multiple regression analysis was used to derive a new equation to predict ALM in patients with obesity and was validated in a subsample of our cohort. RESULTS: In this study, 115 patients (72.4% women) with severe obesity (mean BMI of 46.1 [5.2] kg/m2) were included (mean age 43.5 [8.6] y). FMDXA was 61.4 (10.1) kg, FMBIA was 57.9 (10.3) kg, and ICC was 0.925 (P < 0.001). Bias was -3.4 (4.4) kg (-5.2%), and LOA was -14.0, +7.3 kg. Using the proprietary equations, ALMDXA was 21.8 (4.7) kg and ALMBIA was 29.0 (6.8) kg with an ICC 0.868, bias +7.3 (4.0) kg (+34.1%) and LOA -0.5, +15.1. When applying other equations for ALM, the ICC for Sergi, et al. was 0.880, the ICC for Kyle, et al. was 0.891, and the best ICC estimation for Yamada, et al. was 0.914 (P < 0.001). Bias was +2.8 (2.8), +4.1 (2.9), and +2.7 (2.8) kg, respectively. The best-fitting regression equation to predict ALMDXA in our population derived from a development cohort (n = 77) was: ALM = 13.861 + (0.259 x H2/Z) - (0.085 x age) - (3.983 x sex [0 = men; 1 = women]). When applied to our validation cohort (n = 38), the ICC was 0.864, and the bias was the lowest compared with the rest of the equations +0.3 (+0.5) kg (+2.7%) LOA -5.4, +6.0 kg. CONCLUSION: BIA using multifrequency BIA in people with obesity is reliable enough for the estimation of FM, with good correlation and low bias to DXA. Regarding the estimation of ALM, BIA showed a good correlation with DXA, although it overestimated ALM, especially when proprietary equations were used. The use of equations developed using the same device improved the prediction, and our new equation showed a low bias for ALM.


Subject(s)
Body Composition , Obesity , Absorptiometry, Photon , Adult , Body Mass Index , Cross-Sectional Studies , Electric Impedance , Female , Humans , Male , Reproducibility of Results
8.
Nutrients ; 13(9)2021 Aug 25.
Article in English | MEDLINE | ID: mdl-34578815

ABSTRACT

(1) Background: Both sarcopenia and disease-related malnutrition (DRM) are unfortunately underdiagnosed and undertreated in our Western hospitals, which could lead to worse clinical outcomes. Our objectives included to determine the impact of low muscle mass (MM) and strength, and also DRM and sarcopenia, on clinical outcomes (length of stay, death, readmissions at three months, and quality of life). (2) Methodology: Prospective cohort study in medical inpatients. On admission, MM and hand grip strength (HGS) were assessed. The Global Leadership Initiative on Malnutrition (GLIM) criteria were used to diagnose DRM and EWGSOP2 for sarcopenia. Assessment was repeated after one week and at discharge. Quality of life (EuroQoL-5D), length of stay (LoS), readmissions and mortality are reported. (3) Results: Two hundred medical inpatients, median 76.0 years-old and 68% with high comorbidity. 27.5% met GLIM criteria and 33% sarcopenia on admission, increasing to 38.1% and 52.3% on discharge. Both DRM and sarcopenia were associated with worse QoL. 6.5% died and 32% readmission in 3 months. The odds ratio (OR) of mortality for DRM was 4.36 and for sarcopenia 8.16. Readmissions were significantly associated with sarcopenia (OR = 2.25) but not with DRM. A higher HGS, but not MM, was related to better QoL, less readmissions (OR = 0.947) and lower mortality (OR = 0.848) after adjusting for age, sex, and comorbidity. (4) Conclusions: In medical inpatients, mostly polymorbid, both DRM but specially sarcopenia are associated with poorer quality of life, more readmissions, and higher mortality. Low HGS proved to be a stronger predictor of worse outcomes than MM.


Subject(s)
Inpatients/statistics & numerical data , Malnutrition/epidemiology , Malnutrition/physiopathology , Sarcopenia/epidemiology , Sarcopenia/physiopathology , Aged , Cohort Studies , Comorbidity , Female , Hand Strength , Humans , Length of Stay/statistics & numerical data , Male , Malnutrition/mortality , Patient Readmission/statistics & numerical data , Prospective Studies , Quality of Life , Sarcopenia/mortality , Spain/epidemiology
9.
Obes Surg ; 31(9): 4033-4044, 2021 09.
Article in English | MEDLINE | ID: mdl-34245426

ABSTRACT

INTRODUCTION: Obesity is a chronic disease associated with other comorbidities, including atherogenic dyslipidemia (AD). Bariatric surgery (BS) has shown to reduce cardiovascular risk (CVR) by achieving a significant weight reduction and improving the lipid profile. Different surgical techniques may have a different effect on the lipoprotein profile. PURPOSE: To evaluate the lipid profile at 3 years after BS according to the surgical technique used and to determine which variables predict variation in the lipid profile at 3 years after BS. METHODS: Retrospective observational study of 206 patients who underwent BS between 2010 and 2019. We analyzed the variation of lipid parameters in the 3 years of follow-up according to the surgical technique, including a group analysis of patients according to whether they had dyslipidemia and whether they were treated or untreated and determined which variables predict variation in the lipid profile at 3 years after BS. RESULTS: There was a significant increase in high-density lipoprotein cholesterol (HDL-c) with sleeve gastrectomy (SG) and a significant decrease in total cholesterol (TC), LDL-cholesterol (LDL-c), non-HDL, and LDL/non-HDL with biliopancreatic diversion (BPD). Variables predicting lipid profile variation were surgical technique and pre-surgery lipoprotein level. CONCLUSIONS: Malabsorptive techniques achieve a greater decrease in TC and LDL-c throughout follow-up and could also improve residual cardiovascular risk (non-HDL and LDL/non-HDL). The type of surgical technique and the presurgery lipid profile predict variation after 3 years of BS.


Subject(s)
Bariatric Surgery , Dyslipidemias , Obesity, Morbid , Cholesterol, HDL , Dyslipidemias/surgery , Gastrectomy , Humans , Obesity, Morbid/surgery , Triglycerides , Weight Loss
10.
Endocrinol Diabetes Nutr (Engl Ed) ; 68(4): 218-226, 2021 Apr.
Article in English | MEDLINE | ID: mdl-34266633

ABSTRACT

Obesity and diabetes are two closely related disorders. Lifestyle changes and drug treatment do not achieve successful diabetes remission. A treatment option for these patients is bariatric surgery (BS). The partial and complete remission rates vary, depending on the type of technique used (restrictive or malabsorptive), with malabsorptive surgery being more effective in terms of both weight reduction and diabetes remission (DR). Different scales (DiaRem, Ad-DiaRem or 5y-Ad-DiaRem) predict the probability of DR after BS, particularly after gastric bypass surgery. Some studies report higher DR rates in surgery with a greater malabsorptive component. Our aim was to study the benefits of BS at one year and 5 years in terms of the weight and blood glucose profile in patients with obesity and type 2 diabetes mellitus; assess percentage DR according to ADA criteria; determine the DR predictive capacity of different scores; and examine which variables predict DR at one and five years after biliopancreatic diversion (BPD). Percentage overweight reduction and the decrease in both blood glucose and HbA1c were greater with BPD. Complete diabetes remission was approximately 80% at one and 5 years after BS. In general, the scores that determine the probability of DR show poor discriminative capacity in malabsorptive surgery. Presurgery HbA1c predicts DR at one and 5 years after BPD. The type of surgery performed should be individualized, based on the severity of diabetes and the specific characteristics of each patient.


Subject(s)
Bariatric Surgery , Diabetes Mellitus, Type 2 , Blood Glucose , Diabetes Mellitus, Type 2/surgery , Glycated Hemoglobin , Humans , Obesity/surgery , Remission Induction , Treatment Outcome
12.
Endocrinol Diabetes Nutr (Engl Ed) ; 68(3): 144-152, 2021 Mar.
Article in English | MEDLINE | ID: mdl-34167693

ABSTRACT

BACKGROUND: Bariatric surgery (BS) is an effective treatment. However, there have been concerns regarding the negative effect on the bone. The aim of this study was to assess changes in bone metabolism and the risk of fracture after biliopancreatic diversion (BPD). MATERIAL AND METHODS: A retrospective analysis of obese patients undergoing BPD between 1998 and 2017 was conducted, and patients with at least 1 year of follow-up were included. The incidence of fracture and of changes in bone metabolism was studied. RESULTS: In total, 216 patients were included (78.2% female), with a mean age of 42.5(10.6) years. The median follow-up was 6.8(IQR 10.2-3.2) years. The mean body mass index (BMI) was 49.7(6.3) kg/m2. 13.2% (n=29) suffered a bone fracture after surgery; the time until the first fracture was 7.9(3.8) years (55.2% secondary to a casual fall). The rate of fracture incidence was 19.6 per 1000 person-years (95%CI: 1.3-2.7), prevalence was 13.4% (95%CI: 8.9-18.0). The risk of bone fractures seems to increase with longer postoperative evolution time. PTH (pg/ml) levels were significantly higher in patients with fractures (1 year, 98.1 vs. 77.8; 5 years, 162.5 vs. 110.3 p<0.05, adjusted HR 1.10; 95%CI 1.01-1.11). Subjects with a higher %EWL had less risk of fractures after surgery (adjusted HR 0.97; 95%CI 0.94-0.99). Moreover, 25(OH)D levels were lower, and osteocalcin and ß-Crosslaps levels were slightly higher (not significant) in patients with fractures. CONCLUSION: BPD is related to important changes in bone metabolism, which can lead to an increased risk of bone fractures. Assessing the risk of fractures should be part of BS patient care.


Subject(s)
Bariatric Surgery , Biliopancreatic Diversion , Bone and Bones/metabolism , Fractures, Bone , Obesity, Morbid , Adult , Bariatric Surgery/adverse effects , Biliopancreatic Diversion/adverse effects , Female , Fractures, Bone/epidemiology , Humans , Male , Middle Aged , Obesity, Morbid/epidemiology , Retrospective Studies
13.
Ars pharm ; 62(2): 190-202, abr.-jun. 2021. ilus, graf
Article in Spanish | IBECS | ID: ibc-202445

ABSTRACT

INTRODUCCIÓN: Los estudios gauge permiten ganar información sobre el desempeño de procesos y son de utilidad para control de calidad, así como identificación de fuentes de variación. El objetivo del presente estudio, fue diseñar y analizar sistemas de medición para los modelos de Heckel y Ryshkewitch-Duckworth para caracterizar materiales, a través de estudios Gauge R&R. MÉTODO: Estudio Gauge R&R cruzado para evaluar el sistema de medición del peso y estudio Gauge R&R anidado para el sistema de la resistencia a la fractura. RESULTADOS: Ambos estudios cumplieron con los supuestos de normalidad, varianza constante e independencia de los datos, por lo que fue posible determinar la significación de las fuentes de variación (factores) mediante un ANOVA así como su porcentaje de contribución. Para el estudio Gauge R&R cruzado los punzones evaluados contribuyen a la variación de la medición de manera significativa y en un 97,38% de la variación total; los operadores contribuyen en menos del 1% y de manera no significativa y no existió interacción parte-operador. Respecto al estudio Gauge R&R anidado, se identificó que el operador no influyó de manera significativa en la variabilidad de la medición y que ésta es atribuible en un 95% a las diferencias existentes entre las tabletas evaluadas. CONCLUSIONES: Se realizó el diseño, ejecución y análisis de los sistemas de medición, destacando que en ambos estudios la principal fuente de variación fueron las partes evaluadas y que los operadores no contribuyen en la variabilidad de las mediciones, por lo que los estudios pueden usarse para evaluar los modelos matemáticos y durante el control estadístico de un proceso


INTRODUCTION: Gauge studies allow gaining information about the performance of processes and are very useful tools for quality control and identification of variability sources. The objective of the present study was design and analyzes measurement systems for the Heckel and Ryshkewitch-Duckworth models for characterizing materials, through Gauge R&R studies. METHOD: Crossed Gauge R&R study for the evaluation of weight measurement system and nested Gauge R&R study for the system of tablet hardness. RESULTS: Both studies fulfilled with the assumptions of normality, constant variance and data independence, therefore it was possible to estimate the significance of variation sources (factors) through ANOVA and their contribution percentage. The crossed Gauge R&R study showed that the flat punches contributed to variability of the measurement in a significant manner in 97.38% of the total variation of the study; operators did it in less than 1% and they were not statistically significant and there was no Part-Operator interaction. With respect to the nested Gauge R&R study, it was found that the operator did not influence in a statistically significant way in the variability of the measurement and it was attributable in 95% to the existing differences between the tablets evaluated. CONCLUSIONS: Design, run and analysis of the measurement systems was performed, we remark that in both of the studies the main source of variability were the parts evaluated and that operators did not contribute to variability in the measurements; therefore, both studies could be used to evaluate the Heckel and Ryshkewitch-Duckworth mathematical models and also for statistical process control


Subject(s)
Models, Theoretical , Tablets/standards , Materials Testing/standards , Quality Control , Reference Values , Flexural Strength , Analysis of Variance , Reproducibility of Results
14.
Drug Dev Ind Pharm ; 47(3): 484-497, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33651641

ABSTRACT

Quality by design, applied to the development of a pharmaceutical drug, demands scientific methodologies, representing a source of information that will allow for a complete understanding the production process and the materials used for its manufacturing. Although the SeDeM system is a tool that enables a rational development of a product, result does not assure that an assessed material or mixture will be successful in terms of compression, hence, further research will be necessary on these features. The objective of this study was to assess and compare two grades of metformin hydrochloride elaboration: crystalline and direct compression using PXRD, the SeDeM expert system, the Heckel and Ryshkewitch-Duckworth models, as well as process control tools such as control charts and process capability indices to characterize and predict the performance of the materials in a direct compression process. The assessment identified that in spite of dealing with two different technical grades of a material with specific critical quality attributes for each one, PXRD analysis showed we dealt with the same crystalline structure, while the SeDeM system profiles obtained have very close values, and the main differences in materials were observed when subjecting them to conditions that simulate a compaction process with the Ryshkewitch-Duckworth model, in which a 46-times higher mechanical resistance was observed in the direct compression material compared with the crystalline one. The statistical control analysis revealed that only the direct compression material could be used to elaborate tablets whose weight variation was always maintained within the specification and control limits.


Subject(s)
Excipients , Metformin , Drug Compounding , Expert Systems , Powders , Tablets
15.
Endocrinol Diabetes Nutr (Engl Ed) ; 68(3): 144-152, 2021 Mar.
Article in English, Spanish | MEDLINE | ID: mdl-33495111

ABSTRACT

BACKGROUND: Bariatric surgery (BS) is an effective treatment. However, there have been concerns regarding the negative effect on the bone. The aim of this study was to assess changes in bone metabolism and the risk of fracture after biliopancreatic diversion (BPD). MATERIAL AND METHODS: A retrospective analysis of obese patients undergoing BPD between 1998 and 2017 was conducted, and patients with at least 1 year of follow-up were included. The incidence of fracture and of changes in bone metabolism was studied. RESULTS: In total, 216 patients were included (78.2% female), with a mean age of 42.5(10.6) years. The median follow-up was 6.8(IQR 10.2-3.2) years. The mean body mass index (BMI) was 49.7(6.3) kg/m2. 13.2% (n=29) suffered a bone fracture after surgery; the time until the first fracture was 7.9(3.8) years (55.2% secondary to a casual fall). The rate of fracture incidence was 19.6 per 1000 person-years (95%CI: 1.3-2.7), prevalence was 13.4% (95%CI: 8.9-18.0). The risk of bone fractures seems to increase with longer postoperative evolution time. PTH (pg/ml) levels were significantly higher in patients with fractures (1 year, 98.1 vs. 77.8; 5 years, 162.5 vs. 110.3 p<0.05, adjusted HR 1.10; 95%CI 1.01-1.11). Subjects with a higher %EWL had less risk of fractures after surgery (adjusted HR 0.97; 95%CI 0.94-0.99). Moreover, 25(OH)D levels were lower, and osteocalcin and ß-Crosslaps levels were slightly higher (not significant) in patients with fractures. CONCLUSION: BPD is related to important changes in bone metabolism, which can lead to an increased risk of bone fractures. Assessing the risk of fractures should be part of BS patient care.

16.
Endocrinol Diabetes Nutr (Engl Ed) ; 68(4): 218-226, 2021 Apr.
Article in English, Spanish | MEDLINE | ID: mdl-33495112

ABSTRACT

Obesity and diabetes are two closely related disorders. Lifestyle changes and drug treatment do not achieve successful diabetes remission. A treatment option for these patients is bariatric surgery (BS). The partial and complete remission rates vary, depending on the type of technique used (restrictive or malabsorptive), with malabsorptive surgery being more effective in terms of both weight reduction and diabetes remission (DR). Different scales (DiaRem, Ad-DiaRem or 5y-Ad-DiaRem) predict the probability of DR after BS, particularly after gastric bypass surgery. Some studies report higher DR rates in surgery with a greater malabsorptive component. Our aim was to study the benefits of BS at one year and 5 years in terms of the weight and blood glucose profile in patients with obesity and type 2 diabetes mellitus; assess percentage DR according to ADA criteria; determine the DR predictive capacity of different scores; and examine which variables predict DR at one and five years after biliopancreatic diversion (BPD). Percentage overweight reduction and the decrease in both blood glucose and HbA1c were greater with BPD. Complete diabetes remission was approximately 80% at one and 5 years after BS. In general, the scores that determine the probability of DR show poor discriminative capacity in malabsorptive surgery. Presurgery HbA1c predicts DR at one and 5 years after BPD. The type of surgery performed should be individualized, based on the severity of diabetes and the specific characteristics of each patient.

17.
Endocrinol. diabetes nutr. (Ed. impr.) ; 67(4): 224-227, abr. 2020. tab
Article in Spanish | IBECS | ID: ibc-194790

ABSTRACT

INTRODUCCIÓN: La desnutrición relacionada con la enfermedad (DRE) está infradiagnosticada e infrarreportada, a pesar de su asociación con un peor pronóstico. La irrupción del big data y la inteligencia artificial aplicada en medicina ha revolucionado la forma de generar conocimiento. El presente estudio tiene como objetivo valorar si una herramienta de big data podría ayudarnos a detectar y conocer la DRE en nuestro hospital. METODOLOGÍA: Estudio retrospectivo descriptivo, utilizando la herramienta Savana Manager®, que permite analizar y extraer de forma automática la información clínica relevante contenida en el texto libre de la historia clínica electrónica. Se realiza una búsqueda con el término «desnutrición», comparando las características de los pacientes con DRE frente a la población de pacientes hospitalizados en el periodo comprendido entre enero de 2012 y diciembre de 2017. RESULTADOS: De 180.279 registros de hospitalización con informe de alta en dicho periodo, solo 4.446 episodios (2,47%) incluían el diagnóstico de desnutrición. La edad media de los pacientes con DRE fue 75 años (DE 16) frente a 59 (DE 25) años de la población global. No hubo diferencias en género (51% varones). El fallecimiento intrahospitalario se produjo en el 7,08% de los pacientes con DRE frente al 2,98% en el grupo general. La estancia mediana fue superior en los pacientes con DRE (8 vs. 5 días, p < 0,0001) y no hubo diferencias significativas en la tasa de reingresos a 72horas. Los diagnósticos más frecuentes asociados a DRE fueron insuficiencia cardíaca (35%), infección respiratoria (23%), infección urinaria (20%) y enfermedad renal crónica (15%). CONCLUSIÓN: El infradiagnóstico de la DRE sigue siendo un problema. Savana Manager® ayuda a conocer mejor el perfil de estos pacientes


INTRODUCTION: Disease-related malnutrition (DRM) is underdiagnosed and underreported despite its well-known association with a worse prognosis. The emergence of Big Data and the application of artificial intelligence in Medicine have revolutionized the way knowledge is generated. The aim of this study is to assess whether a Big Data tool could help us detect the amount of DRM in our hospital. METHODOLOGY: This was a descriptive, retrospective study using the Savana Manager® tool, which allows for automatically analyzing and extracting the relevant clinical information contained in the free text of the electronic medical record. A search was performed using the term "malnutrition", comparing the characteristics of patients with DRM to the population of hospitalized patients between January 2012 and December 2017. RESULTS: Among the 180,279 hospitalization records with a discharge report in that period, only 4,446 episodes (2.47%) included the diagnosis of malnutrition. The mean age of patients with DRM was 75 years (SD 16), as compared to 59 years (SD 25) for the overall population. There were no sex differences (51% male). In-hospital death occurred in 7.08% of patients with DRM and 2.98% in the overall group. Mean stay was longer in patients with DRM (8 vs. 5 days, P<.0001) and there were no significant differences in the 72-hour readmission rate. The most common diagnoses associated with DRM were heart failure (35%), respiratory infection (23%), urinary infection (20%), and chronic kidney disease (15%). CONCLUSIÓN: Underdiagnosis of DRM remains a problem. Savana Manager® helps us to better understand the profile of these patients


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Malnutrition/etiology , Chronic Disease , Hospitalization , Big Data , Electronic Health Records , Retrospective Studies
18.
Endocrinol Diabetes Nutr (Engl Ed) ; 67(4): 224-227, 2020 Apr.
Article in English, Spanish | MEDLINE | ID: mdl-32147443

ABSTRACT

INTRODUCTION: Disease-related malnutrition (DRM) is underdiagnosed and underreported despite its well-known association with a worse prognosis. The emergence of Big Data and the application of artificial intelligence in Medicine have revolutionized the way knowledge is generated. The aim of this study is to assess whether a Big Data tool could help us detect the amount of DRM in our hospital. METHODOLOGY: This was a descriptive, retrospective study using the Savana Manager® tool, which allows for automatically analyzing and extracting the relevant clinical information contained in the free text of the electronic medical record. A search was performed using the term "malnutrition", comparing the characteristics of patients with DRM to the population of hospitalized patients between January 2012 and December 2017. RESULTS: Among the 180,279 hospitalization records with a discharge report in that period, only 4,446 episodes (2.47%) included the diagnosis of malnutrition. The mean age of patients with DRM was 75 years (SD 16), as compared to 59 years (SD 25) for the overall population. There were no sex differences (51% male). In-hospital death occurred in 7.08% of patients with DRM and 2.98% in the overall group. Mean stay was longer in patients with DRM (8 vs. 5 days, P<.0001) and there were no significant differences in the 72-hour readmission rate. The most common diagnoses associated with DRM were heart failure (35%), respiratory infection (23%), urinary infection (20%), and chronic kidney disease (15%). CONCLUSION: Underdiagnosis of DRM remains a problem. Savana Manager® helps us to better understand the profile of these patients.


Subject(s)
Big Data , Malnutrition/etiology , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Malnutrition/epidemiology , Middle Aged , Retrospective Studies
19.
Endocrinol. diabetes nutr. (Ed. impr.) ; 67(1): 13-19, ene. 2020. tab
Article in English | IBECS | ID: ibc-186142

ABSTRACT

Background: Head and neck cancer patients have a high rate of complications during the postoperative period that could increase their morbidity rate. Arginine has been shown to improve healing and to modulate inflammation and immune response. The aim of our study was to assess whether use of arginine-enriched enteral formulas could decrease fistulas and length of stay (LoS). Methods. A retrospective study was conducted in patients who had undergone head and neck cancer surgery and were receiving enteral nutrition through a nasogastric tube in the postoperative period between January 2012 and May 2018. The differences associated to use of immunoformula vs. standard formulas were analysed. Sociodemographic, anthropometric, and nutritional intervention variables, as well as nutritional parameters, were recorded during the early postoperative period. Occurrence of complications (fistulas), length of hospital stay, readmissions, and 90-day mortality were recorded. Results: In a univariate analysis, patients who received nutritional support with immunonutrition had a lower fistula occurrence rate (17.91% vs. 32.84%; p = 0.047) and a shorter mean LoS [28.25 (SD 16.11) vs. 35.50 (SD 25.73) days; p = 0.030]. After adjusting for age, energy intake, aggressiveness of surgery and tumour stage, fistula occurrence rate and LoS were similar in both groups irrespective of the type of formula. Conclusions: Use of arginine-enriched enteral nutrition appears to decrease the occurrence of fistulas in the postoperative period in patients with head and neck cancer, with a resultant reduction in length of hospital stay. However, the differences disappeared after adjusting for age, tumour stage, or aggressiveness of the surgery


Introducción: El postoperatorio de los pacientes con cáncer de cabeza y cuello presenta una alta tasa de complicaciones. Esta circunstancia podría aumentar la morbilidad en estos pacientes. La arginina ha demostrado mejorar la curación y modular la inflamación y la respuesta inmune. Nuestro planteamiento es valorar si el uso de fórmulas de alimentación enteral enriquecidas con arginina podría reducir la aparición de fístulas y la duración de la estancia hospitalaria. Métodos: Estudio retrospectivo en pacientes intervenidos de cáncer de cabeza y cuello que recibieron nutrición enteral a través de una sonda nasogástrica en el periodo postoperatorio entre enero de 2012 y mayo de 2018. Se analizaron las diferencias asociadas a la utilización de inmunofórmula vs. fórmulas estándar. Se recogieron variables sociodemográficas, antropométricas, de intervención nutricional y de parámetros nutricionales durante el postoperatorio inmediato, así como la aparición de complicaciones (fístulas), la duración de la estancia hospitalaria, los reingresos y la mortalidad a 90 días. Resultados: En el análisis univariante los pacientes que recibieron apoyo nutricional con inmunonutrición presentaron menor tasa de aparición de fístulas (17,91 vs. 32,84%; p = 0,047) y menor estancia hospitalaria (28,25 [DE 16,11] vs. 35,50 [DE 25,73] días; p = 0,030). Después de ajustar por edad, aporte calórico, agresividad de la cirugía y estadio del tumor, la incidencia de fístula y la estancia hospitalaria fueron similares entre los grupos, independientemente del tipo de fórmula. Conclusiones: El uso de nutrición enteral enriquecida con arginina en pacientes con cáncer de cabeza y cuello intervenidos podría reducir el desarrollo de la fístula y la duración de la estancia hospitalaria; sin embargo, las diferencias observadas desaparecen después de ajustar por edad, estadio tumoral o agresividad de la cirugía


Subject(s)
Humans , Male , Female , Middle Aged , Enteral Nutrition/methods , Postoperative Care , Head and Neck Neoplasms/diet therapy , Food, Formulated , Nutritional Support/methods , Retrospective Studies , Length of Stay , Arginine
20.
Endocrinol Diabetes Nutr (Engl Ed) ; 67(1): 13-19, 2020 Jan.
Article in English, Spanish | MEDLINE | ID: mdl-31474502

ABSTRACT

BACKGROUND: Head and neck cancer patients have a high rate of complications during the postoperative period that could increase their morbidity rate. Arginine has been shown to improve healing and to modulate inflammation and immune response. The aim of our study was to assess whether use of arginine-enriched enteral formulas could decrease fistulas and length of stay (LoS). METHODS: A retrospective study was conducted in patients who had undergone head and neck cancer surgery and were receiving enteral nutrition through a nasogastric tube in the postoperative period between January 2012 and May 2018. The differences associated to use of immunoformula vs. standard formulas were analysed. Sociodemographic, anthropometric, and nutritional intervention variables, as well as nutritional parameters, were recorded during the early postoperative period. Occurrence of complications (fistulas), length of hospital stay, readmissions, and 90-day mortality were recorded. RESULTS: In a univariate analysis, patients who received nutritional support with immunonutrition had a lower fistula occurrence rate (17.91% vs. 32.84%; p=0.047) and a shorter mean LoS [28.25 (SD 16.11) vs. 35.50 (SD 25.73) days; p=0.030]. After adjusting for age, energy intake, aggressiveness of surgery and tumour stage, fistula occurrence rate and LoS were similar in both groups irrespective of the type of formula. CONCLUSIONS: Use of arginine-enriched enteral nutrition appears to decrease the occurrence of fistulas in the postoperative period in patients with head and neck cancer, with a resultant reduction in length of hospital stay. However, the differences disappeared after adjusting for age, tumour stage, or aggressiveness of the surgery.


Subject(s)
Arginine/administration & dosage , Enteral Nutrition/methods , Head and Neck Neoplasms/surgery , Malnutrition/therapy , Postoperative Care/methods , Aged , Analysis of Variance , Case-Control Studies , Cutaneous Fistula/epidemiology , Cutaneous Fistula/prevention & control , Energy Intake , Enteral Nutrition/statistics & numerical data , Female , Food, Formulated , Head and Neck Neoplasms/blood , Head and Neck Neoplasms/complications , Head and Neck Neoplasms/pathology , Humans , Length of Stay , Male , Malnutrition/complications , Malnutrition/immunology , Nutritional Status , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Regression Analysis , Retrospective Studies , Treatment Outcome
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