Glucose metabolism outcomes after pituitary surgery in patients with acromegaly.

AIM: To investigate the impact of pituitary surgery on glucose metabolism and to identify predictors of remission of diabetes after pituitary surgery in patients with acromegaly. METHODS: A national multicenter retrospective study of patients with acromegaly undergoing transsphenoidal surgery for the first time at 33 tertiary Spanish hospitals (ACRO-SPAIN study) was performed. Surgical remission of acromegaly was evaluated according to the 2000 and 2010 criteria. RESULTS: A total of 604 acromegaly patients were included in the study with a total median follow up of 91 months (interquartile range [IQR] 45-163). At the acromegaly diagnosis, 23.8% of the patients had diabetes mellitus (DM) with a median glycated hemoglobin (HbA1c) of 6.9% (IQR 6.4-7.9) [51.9 mmol/mol (IQR 46.4-62.8)]. In the multivariate analysis, older age (odds ratio [OR] 1.02, 95% CI 1.00-1.05), dyslipidemia (OR 5.25, 95% CI 2.81 to 9.79), arthropathy (OR 1.39, 95% CI 2.82 to 9.79), and higher IGF-I levels (OR 1.30, 95% CI 1.05 to 1.60) were associated with a greater prevalence of DM. At the last follow-up visit after surgery, 21.1% of the DM patients (56.7% of them with surgical remission of acromegaly) experienced diabetes remission. The cure rate of DM was more common in older patients (hazard ratio [HR] 1.77, 95% CI 1.31 to 2.43), when surgical cure was achieved (HR 2.10, 95% CI 1.01 to 4.37) and when anterior pituitary function was not affected after surgery (HR 3.38, 95% CI 1.17 to 9.75). CONCLUSION: Glucose metabolism improved in patients with acromegaly after surgery and 21% of the diabetic patients experienced diabetes remission; being more frequent in patients of older age, and those who experienced surgical cure and those with preserved anterior pituitary function after surgery.

Pegvisomant and pasireotide in PRL and GH co-secreting vs GH-secreting Pit-NETs.

The objective of the study was to evaluate the efficacy of second-line therapies in patients with acromegaly caused by a growth hormone (GH) and prolactin (PRL) co-secreting pituitary neuroendocrine tumor (GH&PRL-Pit-NET) compared to their efficacy in patients with acromegaly caused by a GH-secreting pituitary neuroendocrine tumor (GH-Pit-NET). This is a multicenter retrospective study of patients with acromegaly on treatment with pasireotide and/or pegvisomant. Patients were classified in two groups: GH&PRL-Pit-NETs when evidence of hyperprolactinemia and immunohistochemistry (IHC) for GH and PRL was positive or if PRL were >200 ng/dL regardless of the PRL-IHC and GH-Pit-NETs when the previously mentioned criteria were not met. A total of 28 cases with GH&PRL-Pit-NETs and 122 with GH-Pit-NETs met the inclusion criteria. GH&PRL-Pit-NETs presented at a younger age, caused hypopituitarism, and were invasive more frequently than GH-Pit-NETs. There were 124 patients treated with pegvisomant and 49 with pasireotide at any time. The efficacy of pegvisomant for IGF-1 normalization was of 81.5% and of pasireotide of 71.4%. No differences in IGF-1 control with pasireotide and with pegvisomant were observed between GH&PRL-Pit-NETs and GH-Pit-NETs. All GH&PRL-Pit-NET cases treated with pasireotide (n = 6) and 82.6% (n = 19/23) of the cases treated with pegvisomant normalized PRL levels. No differences in the rate of IGF-1 control between pegvisomant and pasireotide were detected in patients with GH&PRL-Pit-NETs (84.9% vs 66.7%, P = 0.178). We conclude that despite the more aggressive behavior of GH&PRL-Pit-NETs than GH-Pit-NETs, no differences in the rate of IGF-1 control with pegvisomant and pasireotide were observed between both groups, and both drugs have shown to be effective treatments to control IGF-1 and PRL hypersecretion in these tumors.

Effectiveness of combined first-line medical treatment in acromegaly with prolactin cosecretion.

OBJECTIVE: The aim of this study is to compare the response to first-line medical treatment in treatment-naive acromegaly patients with pure growth hormone (GH)-secreting pituitary adenoma (GH-PA) and those with GH and prolactin cosecreting PA (GH&PRL-PA). DESIGN: This is a retrospective multicentric study of acromegaly patients followed from 2003 to 2023 in 33 tertiary Spanish hospitals with at least 6 months of first-line medical treatment. METHODS: Baseline characteristics, first-line medical treatment strategies, and outcomes were analyzed. We employed a multiple logistic regression full model to estimate the impact of some baseline characteristics on disease control after each treatment modality. RESULTS: Of the 144 patients included, 72.9% had a GH-PA, and 27.1% had a GH&PRL-PA. Patients with GH&PRL-PA were younger (43.9 ± 15.0 vs 51.9 ± 12.7 years, P < .01) and harboring more frequently macroadenomas (89.7% vs 72.1%, P = .03). First-generation somatostatin receptor ligand (fgSRL) as monotherapy was given to 106 (73.6%) and a combination treatment with fgSRL and cabergoline in the remaining 38 (26.4%). Patients with GH&PRL-PA received more frequently a combination therapy (56.4% vs 15.2%, P < .01). After 6 months of treatment, in the group of patients under fgSRL as monotherapy, those patients with GH&PRL-PA had worse control compared to GH-PAs (29.4% vs 55.1%, P = .04). However, these differences in the rate of disease control between both groups disappeared when both received combination treatment with fgSRL and cabergoline. CONCLUSION: In GH&PRL-PA, the biochemical control achieved with fgSRL as monotherapy is substantially worse than in patients harboring GH-PA, supporting the inclusion of cabergoline as first-line medical treatment in combination with fgSRLs in these subgroups of patients.

Differences between GH and PRL co-secreting and GH-secreting pituitary adenomas. A series of 604 cases.

PURPOSE: To evaluate differences in clinical presentation and in surgical outcomes between growth hormone-secreting pituitary adenomas (GH-PAs) and GH and prolactin co-secreting pituitary adenomas (GH&PRL-PAs). METHODS: Multicenter retrospective study of 604 patients with acromegaly submitted to pituitary surgery. Patients were classified into two groups according to serum PRL levels at diagnosis and immunohistochemistry (IHC) for PRL: a) GH&PRL-PAs when PRL levels were above the upper limit of normal and IHC for GH and PRL was positive or PRL levels were >100ng/and PRL IHC was not available (n=130) and b) GH-PAs who did not meet the previously mentioned criteria (n=474). RESULTS: GH&PRL-PAs represented 21.5% (n=130) of patients with acromegaly. The mean age at diagnosis was lower in GH&PRL-PAs than in GH-PAs (P<0.001). GH&PRL-PAs were more frequently macroadenomas (90.6% vs. 77.4%, P=0.001) and tended to be more invasive (33.6% vs. 24.7%, P=0.057) than GH-PAs. Furthermore, they had presurgical hypopituitarism more frequently (OR 2.8, 95% CI 1.83-4.38). IGF-1 upper limit of normality (ULN) levels at diagnosis were lower in patients with GH&PRL-PAs (median 2.4 [IQR 1.73-3.29] vs. 2.7 [IQR 1.91-3.67], P=0.023). There were no differences in the immediate (41.1% vs 43.3%, P=0.659) or long-term post-surgical acromegaly biochemical cure rate (53.5% vs. 53.1%, P=0.936) between groups. However, there was a higher incidence of permanent arginine-vasopressin deficiency (AVP-D) (7.3% vs. 2.4%, P=0.011) in GH&PRL-PAs patients. CONCLUSIONS: GH&PRL-PAs are responsible for 20% of acromegaly cases. These tumors are more invasive, larger and cause hypopituitarism more frequently than GH-PAs and are diagnosed at an earlier age. The biochemical cure rate is similar between both groups, but patients with GH&PRL-PAs tend to develop permanent postsurgical AVP-D more frequently.

Aetiological diagnosis of hyponatraemia in non-critical patients on total parenteral nutrition: A prospective multicentre study.

BACKGROUND: In patients receiving total parenteral nutrition (TPN), the frequency of hyponatraemia is high. However, the causes of hyponatraemia in TPN have not been elucidated, although diagnosis is required for appropriate therapy. The aim of this study is to describe the aetiology of hyponatraemia in non-critical hospitalised patients receiving TPN. METHODS: Prospective multicentre study in 19 Spanish hospitals. Non-critically hyponatraemic patients receiving TPN and presenting hyponatraemia over a 9-month period were studied. Data collected included sex, age, previous comorbidities, and serum sodium levels (SNa) before and following TPN initiation. Parameters for study of hyponatraemia were also included: clinical volaemia, the presence of pain, nausea, gastrointestinal losses, diuretic use, oedema, renal function, plasma and urine osmolality, urinary electrolytes, cortisolaemia, and thyroid stimulating hormone. RESULTS: 162 patients were included, 53.7% males, age 66.4 (SD13.8) years. Volume status was evaluated in 142 (88%): 21 (14.8%) were hypovolaemic, 96 (67.6%) euvolaemic and 25 (17.6%) hypervolaemic. In 111/142 patients the analytical assessment of hyponatraemia was completed. Hypovolaemic hyponatraemia was secondary to GI losses in 10/111 (9%), and to diuretics in 3/111 (2.7%). Euvolaemic hyponatraemia was due to Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH) in 47/111 (42.4%), and to physiological stimuli of Arginine Vasopressin (AVP) secretion in 28/111 (25.2%). Hypervolaemic hyponatraemia was induced by heart failure in 19/111 (17.1%), cirrhosis of the liver in 4/111 (3.6%). CONCLUSIONS: SIADH was the most frequent cause of hyponatraemia in patients receiving TPN. The second most frequent cause was physiological stimuli of AVP secretion induced by pain/nausea.

Evidence-based recommendations of the Andalusian Group for Nutrition Reflection and Investigation (GARIN) for the management of adult patients with short bowel syndrome.

INTRODUCTION: In order to develop evidence-based recommendations and expert consensus for the nutritional management of patients with short bowel syndrome (SBS), we conducted a systematic literature search using the PRISMA methodology plus a critical appraisal following the GRADE scale procedures. Pharmacological treatment with antisecretory drugs, antidiarrheal drugs, and somatostatin contributes to reducing intestinal losses. Nutritional support is based on parenteral nutrition; however, oral intake and/or enteral nutrition should be introduced as soon as possible. In the chronic phase, the diet should have as few restrictions as possible, and be adapted to the SBS type. Home parenteral nutrition (HPN) should be individualized. Single-lumen catheters are recommended and taurolidine should be used for locking the catheter. The HPN's lipid content must be greater than 1 g/kg per week but not exceed 1 g/kg per day, and omega-6 fatty acids (ω6 FAs) should be reduced. Trace element vials with low doses of manganese should be used. Patients with chronic SBS who require long-term HPN/fluid therapy despite optimized treatment should be considered for teduglutide treatment. All patients require a multidisciplinary approach and specialized follow-up. These recommendations and suggestions regarding nutritional management in SBS patients have direct clinical applicability.

INTRODUCCIÓN: Con el fin de desarrollar recomendaciones basadas en la evidencia y el consenso de expertos para el manejo nutricional de los pacientes con síndrome de intestino corto (SIC), realizamos una búsqueda bibliográfica sistemática utilizando la metodología PRISMA junto a una valoración crítica siguiendo los procedimientos de la escala GRADE. El tratamiento farmacológico con fármacos antisecretores, antidiarreicos y somatostatina contribuye a reducir las pérdidas intestinales. El apoyo nutricional se basa en la nutrición parenteral; sin embargo, la ingesta oral y/o la nutrición enteral deben introducirse lo antes posible. En la fase crónica, la dieta debe tener las menores restricciones posibles y adaptarse al tipo de SIC. La nutrición parenteral domiciliaria (NPD) debe individualizarse. Se recomiendan catéteres de un solo lumen y se debe utilizar taurolidina para bloquear el catéter. El contenido de lípidos de la HPN debe ser superior a 1 g/kg por semana, pero no debe exceder 1 g/kg por día, y debe reducirse el ácido graso omega-6 (AG ω6). Deben utilizarse viales de oligoelementos con dosis bajas de manganeso. Los pacientes con SIC crónico que requieren NPD/fluidoterapia a largo plazo a pesar del tratamiento optimizado deben considerarse para el tratamiento con teduglutida. Todos los pacientes requieren un abordaje multidisciplinar y un seguimiento especializado. Estas recomendaciones y sugerencias con respecto al manejo nutricional de los pacientes con SIC tienen aplicabilidad clínica directa.

Aetiological diagnosis of hyponatraemia in non-critical patients on total parenteral nutrition: A prospective multicentre study.

BACKGROUND: In patients receiving total parenteral nutrition (TPN), the frequency of hyponatraemia is high. However, the causes of hyponatraemia in TPN have not been elucidated, although diagnosis is required for appropriate therapy. The aim of this study is to describe the aetiology of hyponatraemia in non-critical hospitalised patients receiving TPN. METHODS: Prospective multicentre study in 19 Spanish hospitals. Non-critically hyponatraemic patients receiving TPN and presenting hyponatraemia over a 9-month period were studied. Data collected included sex, age, previous comorbidities, and serum sodium levels (SNa) before and following TPN initiation. Parameters for study of hyponatraemia were also included: clinical volaemia, the presence of pain, nausea, gastrointestinal losses, diuretic use, oedema, renal function, plasma and urine osmolality, urinary electrolytes, cortisolaemia, and thyroid stimulating hormone. RESULTS: 162 patients were included, 53.7% males, age 66.4 (SD13.8) years. Volume status was evaluated in 142 (88%): 21 (14.8%) were hypovolaemic, 96 (67.6%) euvolaemic and 25 (17.6%) hypervolaemic. In 111/142 patients the analytical assessment of hyponatraemia was completed. Hypovolaemic hyponatraemia was secondary to GI losses in 10/111 (9%), and to diuretics in 3/111 (2.7%). Euvolaemic hyponatraemia was due to Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH) in 47/111 (42.4%), and to physiological stimuli of Arginine Vasopressin (AVP) secretion in 28/111 (25.2%). Hypervolaemic hyponatraemia was induced by heart failure in 19/111 (17.1%), cirrhosis of the liver in 4/111 (3.6%). CONCLUSIONS: SIADH was the most frequent cause of hyponatraemia in patients receiving TPN. The second most frequent cause was physiological stimuli of AVP secretion induced by pain/nausea.

Recommendations Based on Evidence by the Andalusian Group for Nutrition Reflection and Investigation (GARIN) for the Pre- and Postoperative Management of Patients Undergoing Obesity Surgery.

In order to develop evidence-based recommendations and expert consensus for nutrition management of patients undergoing bariatric surgery and postoperative follow-up, we conducted a systematic literature search using PRISMA methodology plus critical appraisal following the SIGN and AGREE-II procedures. The results were discussed among all members of the GARIN group, and all members answered a Likert scale questionnaire to assess the degree of support for every recommendation. Patients undergoing bariatric surgery should be screened preoperatively for some micronutrient deficiencies and treated accordingly. A VLCD (Very Low-Calorie Diet) should be used for 4-8 weeks prior to surgery. Postoperatively, a liquid diet should be maintained for a month, followed by a semi-solid diet also for one month. Protein requirements (1-1.5 g/kg) should be estimated using adjusted weight. Systematic use of specific multivitamin supplements is encouraged. Calcium citrate and vitamin D supplements should be used at higher doses than are currently recommended. The use of proton-pump inhibitors should be individualised, and vitamin B12 and iron should be supplemented in case of deficit. All patients, especially pregnant women, teenagers, and elderly patients require a multidisciplinary approach and specialised follow-up. These recommendations and suggestions regarding nutrition management when undergoing bariatric surgery and postoperative follow-up have direct clinical applicability.

25-hydroxyvitamin D levels in the early healing of osteoporotic hip fracture and their relationship with clinical outcome / Niveles de 25-hidroxivitamina D en la fase precoz de la fractura osteoporótica de cadera y su relación con los resultados clínicos

INTRODUCTION: vitamin D is involved in recovery after an osteoporotic hip fracture (OHF). Previous studies have reported decreased serum vitamin D levels during fracture healing. OBJECTIVES: our aim was to evaluate: a) serum 25-hydroxyvitamin D3 (25OHD3) levels in patients with OHF at hospital admission and 8 days post-admission, and b) the relationship between 25OHD levels and clinical outcomes. METHODS: a prospective study including 66 patients aged over 65 years hospitalized for OHF. We gathered data on baseline demographic characteristics, medical history, Mini Mental State (MMS) assessment, Activities of Daily Living (ADL) results, nutritional assessment, and type of fracture and surgery. Laboratory results were collected on bone biomarkers, albumin, 25OHD3, and IL6. Clinical outcomes included length of stay, complications, and mortality. In the statistical analysis, a t-test was used for continuous variables and a chi-square test for qualitative variables. Linear regression models were used for the multivariate analysis, adjusted for covariates. RESULTS: our study population had low serum vitamin D levels at admission, with a mean [(standard error of the mean (SEM)] of 12.04 (1.03) ng/mL. Both 25OHD3 and interleukin 6 (IL-6) levels significantly declined (p < 0.001) during the early post-fracture phase. A greater decline in 25OHD3 levels was significantly associated with longer hospital stay (p = 0.042, multivariate analysis). Serum 25OHD3 levels were also associated with cognitive status as assessed using the MMS exam. CONCLUSIONS: 25OHD3 levels were reduced in OHF patients at admission, and significantly decreased during the first 8 days post-admission. 25OHD3 levels were associated with MMS-assessed cognitive status. A greater decline in serum 25OHD3 was associated with a longer hospital stay

INTRODUCCIÓN: la vitamina D se ha relacionado con la recuperación tras la fractura osteoporótica de cadera (FOC). Estudios previos muestran un descenso de los niveles de vitamina D en la fase precoz tras la fractura. OBJETIVOS: evaluar: a) los niveles séricos de 25-hidroxivitamina D3 (25OHD3) al ingreso y a los 8 días del ingreso en hospitalizados por FOC; b) la relación de los niveles de 25OHD3 con los resultados clínicos, así como con el nivel cognitivo y funcional. MÉTODOS: estudio prospectivo de 66 pacientes (> 65 años) ingresados por FOC. Se estudiaron las características demográficas, los antecedentes personales, la valoración nutricional, el test Mini Mental State (MMS), el cuestionario Activities of Daily Living (ADL), el tipo de fractura y de cirugía, y parámetros bioquímicos del metabolismo óseo, la 25OHD3, la albúmina y la interleuquina 6. Como resultados clínicos se analizaron: estancia hospitalaria, complicaciones y mortalidad durante el ingreso. El análisis estadístico consistió en: a) prueba de la t para las variables continuas y χ2 para las cualitativas; b) análisis multivariable utilizando modelos de regresión lineal ajustados según el análisis de la covarianza. RESULTADOS: la población estudiada muestra niveles bajos de 25OHD3 al ingreso: media [± error estándar de la media (EEM)] = 12,04 (1,03) ng/mL. Durante el ingreso, 25OHD3 e interleuquina 6 decrecen significativamente (p < 0,001). El descenso de 25OHD3 se asocia con la estancia hospitalaria (p = 0,042 en análisis multivariable). Los valores disminuidos de 25OHD3 se asocian a un bajo nivel cognitivo (p = 0,042). CONCLUSIONES: los pacientes ingresados por fractura osteoporótica de cadera tienen niveles bajos de 25OHD3 que decrecen significativamente tras 8 días de ingreso. El descenso de 25OHD3 se asocia significativamente a la estancia hospitalaria. Los niveles disminuidos de 25OHD3 se asocian a un peor estado cognitivo evaluado mediante el MMS

Effects of Probiotics on Metabolic Syndrome: A Systematic Review of Randomized Clinical Trials.

The aim of this systematic review is to evaluate whether the use of probiotics has any effect on the components of metabolic syndrome (MetS) before patients develop type 2 diabetes. A qualitative systematic review, following the Cochrane methodology, and a comprehensive literature search of randomized controlled trials (RCTs) were conducted in PubMed and Scopus from inception until 4 July 2019. According to our inclusion criteria, nine clinical studies were finally analyzed, corresponding to six RCTs. Probiotics intake in patients with MetS resulted in improvements in body mass index, blood pressure, glucose metabolism, and lipid profile in some studies. Regarding inflammatory biomarkers, probiotics also positively affected the soluble vascular cell adhesion molecule 1 (sVCAM-1), interleukine-6 (IL-6), tumor necrosis factor α (TNF-α), vascular endothelial growth factor (VEGF), and thrombomodulin. Despite the diversity of the published studies, the intake of probiotics for patients with MetS may offer a discrete improvement in some of the clinical characteristics of the MetS and a decrease in inflammatory biomarkers. Nevertheless, these beneficial effects seem to be marginal compared to drug therapy and a healthy lifestyle and clinically non-relevant.

25-hydroxyvitamin D levels in the early healing of osteoporotic hip fracture and their relationship with clinical outcome.

INTRODUCTION: Introduction: vitamin D is involved in recovery after an osteoporotic hip fracture (OHF). Previous studies have reported decreased serum vitamin D levels during fracture healing. Objectives: our aim was to evaluate: a) serum 25-hydroxyvitamin D3 (25OHD3) levels in patients with OHF at hospital admission and 8 days post-admission, and b) the relationship between 25OHD levels and clinical outcomes. Methods: a prospective study including 66 patients aged over 65 years hospitalized for OHF. We gathered data on baseline demographic characteristics, medical history, Mini Mental State (MMS) assessment, Activities of Daily Living (ADL) results, nutritional assessment, and type of fracture and surgery. Laboratory results were collected on bone biomarkers, albumin, 25OHD3, and IL6. Clinical outcomes included length of stay, complications, and mortality. In the statistical analysis, a t-test was used for continuous variables and a chi-square test for qualitative variables. Linear regression models were used for the multivariate analysis, adjusted for covariates. Results: our study population had low serum vitamin D levels at admission, with a mean [(standard error of the mean (SEM)] of 12.04 (1.03) ng/mL. Both 25OHD3 and interleukin 6 (IL-6) levels significantly declined (p < 0.001) during the early post-fracture phase. A greater decline in 25OHD3 levels was significantly associated with longer hospital stay (p = 0.042, multivariate analysis). Serum 25OHD3 levels were also associated with cognitive status as assessed using the MMS exam. Conclusions: 25OHD3 levels were reduced in OHF patients at admission, and significantly decreased during the first 8 days post-admission. 25OHD3 levels were associated with MMS-assessed cognitive status. A greater decline in serum 25OHD3 was associated with a longer hospital stay.

INTRODUCCIÓN: Introducción: la vitamina D se ha relacionado con la recuperación tras la fractura osteoporótica de cadera (FOC). Estudios previos muestran un descenso de los niveles de vitamina D en la fase precoz tras la fractura. Objetivos: evaluar: a) los niveles séricos de 25-hidroxivitamina D3 (25OHD3) al ingreso y a los 8 días del ingreso en hospitalizados por FOC; b) la relación de los niveles de 25OHD3 con los resultados clínicos, así como con el nivel cognitivo y funcional. Métodos: estudio prospectivo de 66 pacientes (> 65 años) ingresados por FOC. Se estudiaron las características demográficas, los antecedentes personales, la valoración nutricional, el test Mini Mental State (MMS), el cuestionario Activities of Daily Living (ADL), el tipo de fractura y de cirugía, y parámetros bioquímicos del metabolismo óseo, la 25OHD3, la albúmina y la interleuquina 6. Como resultados clínicos se analizaron: estancia hospitalaria, complicaciones y mortalidad durante el ingreso. El análisis estadístico consistió en: a) prueba de la t para las variables continuas y χ2 para las cualitativas; b) análisis multivariable utilizando modelos de regresión lineal ajustados según el análisis de la covarianza. Resultados: la población estudiada muestra niveles bajos de 25OHD3 al ingreso: media [± error estándar de la media (EEM)] = 12,04 (1,03) ng/mL. Durante el ingreso, 25OHD3 e interleuquina 6 decrecen significativamente (p < 0,001). El descenso de 25OHD3 se asocia con la estancia hospitalaria (p = 0,042 en análisis multivariable). Los valores disminuidos de 25OHD3 se asocian a un bajo nivel cognitivo (p = 0,042). Conclusiones: los pacientes ingresados por fractura osteoporótica de cadera tienen niveles bajos de 25OHD3 que decrecen significativamente tras 8 días de ingreso. El descenso de 25OHD3 se asocia significativamente a la estancia hospitalaria. Los niveles disminuidos de 25OHD3 se asocian a un peor estado cognitivo evaluado mediante el MMS.

Lactobacillus reuteri V3401 Reduces Inflammatory Biomarkers and Modifies the Gastrointestinal Microbiome in Adults with Metabolic Syndrome: The PROSIR Study.

Previous studies have reported that probiotics may improve clinical and inflammatory parameters in patients with obesity and metabolic syndrome (MetS). Lactobacillus (L.) reuteri V3401 has shown promising results on the components of MetS in animal studies. We aimed to evaluate the effects of L. reuteri V3401 together with healthy lifestyle recommendations on adult patients with MetS. METHODS: We carried out a randomized, crossover, placebo-controlled, single-center trial in which we included 53 adult patients newly diagnosed with MetS. Patients were block randomly allocated by body mass index (BMI) and sex to receive a capsule containing either the probiotic L. reuteri V3401 (5 × 109 colony-forming units) or a placebo once daily for 12 weeks. Anthropometric variables, biochemical and inflammatory biomarkers, as well as the gastrointestinal microbiome composition were determined. RESULTS: There were no differences between groups in the clinical characteristics of MetS. However, we found that interleukin-6 (IL-6) and soluble vascular cell adhesion molecule 1 (sVCAM-1) diminished by effect of the treatment with L. reuteri V3401. Analysis of the gastrointestinal microbiome revealed a rise in the proportion of Verrucomicrobia. CONCLUSIONS: Consumption of L. reuteri V3401 improved selected inflammatory parameters and modified the gastrointestinal microbiome. Further studies are needed to ascertain additional beneficial effects of other probiotic strains in MetS as well as the mechanisms by which such effects are exerted.

Cognitive impairment and health-related quality of life following traumatic brain injury.

BACKGROUND: Cognitive impairment is a common and disabling consequence of traumatic brain injury (TBI) but its impact on health-related quality of life is not well understood. OBJECTIVE: To investigate the relationship between cognitive impairment and health-related quality of life (HRQoL) after TBI. METHODS: Retrospective, cross-sectional study of a specialist TBI outpatient clinic patient sample. OUTCOME MEASURES: Addenbrooke's Cognitive Examination Tool - Revised (ACE-R), and SF-36 quality of life, Beck Depression Inventory II (BDI-II), Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) questionnaires. RESULTS: 240 adults were assessed: n = 172 (71.7%) moderate-severe, 41 (23.8%) mild, 27 (11.3%) symptomatic TBI, 174 (72.5%) male, median age (range): 44 (22-91) years. TBI patients reported poorer scores on all domains of SF-36 compared to age-matched UK normative data. Cognitively impaired patients reported poorer HRQoL on the physical, social role and emotional role functioning, and mental health domains. Cognitive impairment predicted poorer HRQoL on the social and emotional role functioning domains, independently of depressive symptoms, sleep disturbance, daytime sleepiness and TBI severity. Mediation analysis revealed that the effect of depressive symptoms on the emotional role functioning domain of HRQoL was partially mediated by cognitive dysfunction. CONCLUSION: Cognitive impairment is associated with worse health-related quality of life after TBI and partially mediates the effect of depressive symptoms on emotional role functioning.

[Spanish home enteral nutrition registry of the year 2016 and 2017 from the NADYA-SENPE Group]. / Registro del grupo nadya-senpe de nutrición enteral domiciliaria en españa; años 2016 y 2017.

INTRODUCTION: Objective: to present the results of the Spanish home enteral nutrition (HEN) registry of the NADYA-SENPE group for the year 2016 and 2017. Material and methods: from January 1st 2016 to December 31st 2017, the HEN registry was recorded and afterwards a further descriptive and analytical analysis was done. Results: in 2016, 4,578 active patients were recorded and prevalence was 98.33 patients per one million inhabitants; in 2017, 4,777 patients were recorded, with a prevalence of 102.57 per one million inhabitants; 50.8% were males in 2016 and 50.5% in 2017. During the period 2016-17, median age was 71.5 years (IIQ 57-83), 1,558 HEN episodes were finished and the main cause was death (793 patients, 50.89%). Adult males were younger than females (65.3 vs. 73.3 years, p-value < 0.001). The most frequent diagnosis was the neurological disorder that presents with aphagia or severe dysphagia (59%). Nasogastric tube was the most frequent administration route (48.3%) and it is the most widely used in elderly patients (p < 0.001). One hundred and twenty-six pediatric patients were registered (57.1% females). Median age at the beginning of HEN in children was four months. "Other disorders" was the most recorded diagnostic group (41.3%), followed by the group of neurological disorder that presents with aphagia or severe dysphagia. Regarding children, 57.6% were fed through gastrostomy and the younger ones were fed through nasogastric tube (p-value 0.001). Conclusions: the number of patients in the registry, as well as the number of participating centers, is progressively increasing. The main characteristics of the patients have not changed. Despite the increase in diagnostic possibilities in the pediatric population, the classification within the group of "Other pathologies" is quite significant.

INTRODUCCIÓN: Objetivo: exponer los resultados del registro de nutrición enteral domiciliaria (NED) de los años 2016 y 2017 del Grupo NADYA-SENPE. Material y métodos: se recopilaron los pacientes introducidos en el registro del 1 de enero al 31 de diciembre de 2016 y la mismas fechas de 2017 para proceder al análisis descriptivo y analítico de los datos. Resultados: en el año 2016 se obtuvieron 4.578 pacientes activos (prevalencia = 98,33 pacientes/millón de habitantes) y en 2017 fueron 4.777 (prevalencia = 102,57). Por sexos, hubo un 50,8% de varones en 2016 y un 50,5% en 2017. En el periodo 2016-17, la edad mediana fue de 71,5 años (IIQ 57-83); asimismo, finalizaron 1.558 episodios de NED y la causa principal fue el fallecimiento (793 pacientes, 50,89%). Los varones adultos fueron más jóvenes que las mujeres (65,3 vs. 73,3 años, p-valor < 0,001) y el diagnóstico más frecuente fue la enfermedad neurológica que cursa con afagia o disfagia severa (59%). La sonda nasogástrica (SNG) fue la vía de acceso más utilizada (48,3%) y se observa, además, que esta es la vía que se utiliza en los pacientes más ancianos (p < 0,001). Se registraron 126 pacientes pediátricos (57,1% niñas). La edad mediana de inicio de la NED fue de cuatro meses. Otras patologías fue el grupo diagnóstico más registrado (41,3%), seguido por la enfermedad neurológica que cursa con afagia o disfagia severa. Se alimentaban a través de gastrostomía en el 57,6% de los casos. Se observó que los niños más pequeños eran los que se alimentaban preferentemente por SNG (p-valor 0,001). Conclusiones: el número de pacientes del registro, así como el número de centros participantes, se va incrementando progresivamente. Las principales características de los pacientes no han variado. A pesar del aumento de posibilidades diagnósticas en la población pediátrica, llama la atención la clasificación dentro del grupo de Otras patologías.

Development of hyponatremia in non-critical patients receiving total parenteral nutrition: A prospective, multicenter study.

BACKGROUND & AIMS: Hyponatremia is frequent in hospitalized patients, especially in those receiving total parenteral nutrition (TPN). Furthermore, the presence of hyponatremia is associated with increased morbimortality in both groups. The goal of this study is to describe the prevalence of hyponatremia developing during TPN in non-critical patients, and identify risk factors for its appearance. METHODS: This prospective multicenter study involved 19 Spanish hospitals. Noncritically-ill patients prescribed TPN over a 9-month period were studied. Variables analyzed demographic characteristics, prior comorbidities, drug therapy, PN composition, additional iv fluids, and serum sodium levels. RESULTS: A total of 543 patients were recruited, 60.2% males. Age: 67 (IR 57-76). Of 466/543 who were eunatremic when starting TPN, 18% developed hyponatremia (serum sodium < 135 mmol/L) during TPN. Independent risk factors identified by logistic regression analysis: female (OR 1.74 [95% CI = 1.04-2.92], p = 0.036); severe malnutrition (OR 2.15 [95% CI = 1.16-4.35], p = 0.033); opiates (OR 1.97 [95% CI = 1.10-3.73], p = 0.036); and nausea/vomiting (OR 1.75 [95% CI = 1.04-2.94], p = 0.036). CONCLUSIONS: Previously eunatremic patients frequently develop hyponatremia while receiving TPN. In this group, severe malnutrition is an independent risk factor for hyponatremia, as well as previously described risk factors: opiates, nausea/vomiting, and female gender.

Evaluation of the effect of Lactobacillus reuteri V3401 on biomarkers of inflammation, cardiovascular risk and liver steatosis in obese adults with metabolic syndrome: a randomized clinical trial (PROSIR).

BACKGROUND: Obesity is characterized by increased fat mass and is associated with the development of insulin resistance syndrome (IRS), usually known as metabolic syndrome. The alteration of the intestinal microbiota composition has a role in the development of IRS associated with obesity, and probiotics, which are live microorganisms that confer a health benefit to the host, contribute to restore intestinal microbiota homeostasis and lower peripheral tissue insulin resistance. We aim to evaluate the effects of the probiotic strain Lactobacillus reuteri (L. reuteri) V3401 on the composition of intestinal microbiota, markers of insulin resistance and biomarkers of inflammation, cardiovascular risk, and hepatic steatosis in patients with overweight and obesity exhibiting IRS. METHODS/DESIGN: We describe a randomized, double-blind, crossover, placebo-controlled, and single-centre trial. Sixty participants (aged 18 to 65 years) diagnosed with IRS will be randomized in a 1:1 ratio to receive either a daily dose of placebo or 5 × 109 colony-forming units of L. reuteri V3401. The study will consist of two intervention periods of 12 weeks separated by a washout period of 6 weeks and preceded by another washout period of 2 weeks. The primary outcome will be the change in plasma lipopolysaccharide (LPS) levels at 12 weeks. Secondary outcomes will include anthropometric parameters, lipid profile, glucose metabolism, microbiota composition, hepatic steatosis, and inflammatory and cardiovascular biomarkers. Blood and stool samples will be collected at baseline, at the midpoint (only stool samples) and immediately after each intervention period. Luminex technology will be used to measure interleukins. For statistical analysis, a mixed ANOVA model will be employed to calculate changes in the outcome variables. DISCUSSION: This is the first time that L. reuteri V3401 will be evaluated in patients with IRS. Therefore, this study will provide valuable scientific information about the effects of this strain in metabolic syndrome patients. TRIAL REGISTRATION: The trial has been retrospectively registered in ClinicalTrials.gov on the 23rd November 2016 (ID: NCT02972567 ), during the recruitment phase.

Esofagitis eosinofílica: consideraciones fisiopatológicas y terapéuticas / Eosinophilic esophagitis: physiopathological and therapeutic aspects

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Prevalence and correlates of vitamin D deficiency in adults after traumatic brain injury.

OBJECTIVES: Traumatic brain injury (TBI) is a major cause of long-term disability with variable recovery. Preclinical studies suggest that vitamin D status influences the recovery after TBI. However, there is no published clinical data on links between vitamin D status and TBI outcomes. The aim was to determine the (i) prevalence of vitamin D deficiency/insufficiency, and associations of vitamin D status with (ii) demographic factors and TBI severity, and with (iii) cognitive function, symptoms and quality of life, in adults after TBI. DESIGN: Retrospective audit of patients seen between July 2009 and March 2015. Serum vitamin D (25-hydroxy-cholecalciferol) was categorized as deficient (<40 nmol/l), insufficient (40-70 nmol/l) or replete (>70 nmol/l). PATIENTS: A total of 353 adults seen in tertiary hospital clinic (75·4% lighter skinned, 74·8% male, age median 35·1 year, range 26·6-48·3 year), 0·3-56·5 months after TBI (74·5% moderate-severe). MEASUREMENTS: Serum vitamin D concentrations; Addenbrooke's Cognitive Examination (ACE-R), Beck Depression Inventory-II (BDI-II), SF-36 Quality of Life, Pittsburgh Sleep Quality Index. RESULTS: In total, 46·5% of patients after TBI had vitamin D deficiency and 80·2% insufficiency/deficiency. Patients with vitamin D deficiency had lower ACE-R scores than those of vitamin D replete (mean effect size ± SEM 4·5 ± 2·1, P = 0·034), and higher BDI-II scores than those of vitamin D insufficient (4·5 ± 1·6, P = 0·003), correcting for age, gender, time since TBI and TBI severity. There was no association between vitamin D status and markers of TBI severity, sleep or quality of life. CONCLUSION: Vitamin D deficiency is common in patients after TBI and associated with impaired cognitive function and more severe depressive symptoms.