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BACKGROUND AND AIMS: To investigate the efficacy and feasibility of three different 8 h time-restricted eating (TRE) schedules (i.e., early, late, and self-selected) compared to each other and to a usual-care (UC) intervention on visceral adipose tissue (VAT) and cardiometabolic health in men and women. METHODS AND RESULTS: Anticipated 208 adults (50% women) aged 30-60 years, with overweight/obesity (25 ≤ BMI<40 kg/m2) and with mild metabolic impairments will be recruited for this parallel-group, multicenter randomized controlled trial. Participants will be randomly allocated (1:1:1:1) to one of four groups for 12 weeks: UC, early TRE, late TRE or self-selected TRE. The UC group will maintain their habitual eating window and receive, as well as the TRE groups, healthy lifestyle education for weight management. The early TRE group will start eating not later than 10:00, and the late TRE group not before 13:00. The self-selected TRE group will select an 8 h eating window before the intervention and maintain it over the intervention. The primary outcome is changes in VAT, whereas secondary outcomes include body composition and cardiometabolic risk factors. CONCLUSION: This study will determine whether the timing of the eating window during TRE impacts its efficacy on VAT, body composition and cardiometabolic risk factors and provide insights about its feasibility.
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Doenças Cardiovasculares , Gordura Intra-Abdominal , Adulto , Masculino , Humanos , Feminino , Composição Corporal , Fatores de Risco Cardiometabólico , Escolaridade , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Jejum , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: In the last years, evidence that dietary vitamin K could have a role in the cognitive domain has increased. However, data from large trials are limited. The objective of this study was to assess the association of 2 year changes in the dietary intake of vitamin K with cognitive function measured through neuropsychological performance tests. METHODS: In 5,533 participants of the multicentre PREDIMED-Plus study (48.1% women, age 65.1 ± 4.9 years with overweight/obesity and metabolic syndrome), we assessed the adjusted odds ratios of cognitive function decline according to 2 year changes in vitamin K intake. Participants answered a battery of cognitive function tests and Food Frequency Questionnaires (FFQs) in order to estimate the vitamin K dietary intake. RESULTS: After adjusting for potential cofounders, the highest tertile of change of dietary vitamin K intake (median [IQR]; 194.4 µg/d [120.9, 373.1]) was inversely associated with a Mini-Mental State Examination (MMSE) score ≤24 (OR [95% CI]; 0.53 [0.35, 0.79] P for trend = 0.002) compared with a decrease in the intake of vitamin K (median [IQR]; -97.8 µg/d [-292.8, -51.5]). A significant positive association between changes in dietary vitamin K intake and the semantic verbal fluency test scores (OR [95% CI]; 0.69 [0.51, 0.94] P for trend = 0.019) was found. CONCLUSIONS: An increase of the intake of dietary vitamin K was associated with better cognitive function scores, independently of recognised risk factors for cognitive decline, in an older adult Mediterranean population with high cardiovascular risk.
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Cognição , Estado Nutricional , Idoso , Ingestão de Alimentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Vitamina KRESUMO
Telerehabilitation interventions administered via a smartphone may provide new feasible and effective rehabilitation options at home for patients with hip fracture. However, to date, no such interventions have been shown to be effective in the recovery key health outcomes of these patients. The present multicentre randomized controlled trial (RCT) aims to test the effect of the ActiveHip+ m-Health system in the recovery of physical performance, functional level, quality of life, and other health-related outcomes in both patients with hip fracture and their family caregivers. A total of 104 patients older than 65 years, with hip fracture, and their family caregivers will be randomized into the ActiveHip+ rehabilitation (N = 52) or the control group (N = 52). ActiveHip+ is a 12-week smartphone-based rehabilitation program conducted in Granada and Cádiz (Spain) that includes: (1) 24 sessions of physical exercise and 12 sessions of occupational therapy; (2) seven educational modules for patients and for caregivers; and (3) general recommendations in activities of daily living. The control group will receive the usual rehabilitation protocol offered by the Andalusian Public Healthcare System. The primary outcome is the patient's physical performance, while the secondary outcomes are the patient's functional level, quality of life, pain, fear of falling, fitness perception, pre-fracture functional level, emotional status, and caregiver burden. The present project will substantially contribute to the existing knowledge by testing for the first time the efficacy and feasibility of a multidisciplinary m-Health system in the rehabilitation of patients with hip fracture.
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Fraturas do Quadril , Telerreabilitação , Cuidadores , Educação em Saúde , Fraturas do Quadril/reabilitação , Humanos , Desempenho Físico Funcional , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Telerreabilitação/métodosRESUMO
OBJECTIVE: The prevalence of carbohydrate metabolism disorders in patients who receive total parenteral nutrition (TPN) is not well known. These disorders can affect the treatment, metabolic control, and prognosis of affected patients. The aims of this study were to determine the prevalence in noncritically ill patients on TPN of diabetes, prediabetes, and stress hyperglycemia; the factors affecting hyperglycemia during TPN; and the insulin therapy provided and the metabolic control achieved. METHODS: We undertook a prospective multicenter study involving 19 Spanish hospitals. Noncritically ill patients who were prescribed TPN were included, and data were collected on demographic, clinical, and laboratory variables (glycated hemoglobin, C-reactive protein [CRP], capillary blood glucose) as well as insulin treatment. RESULTS: The study included 605 patients. Before initiation of TPN, the prevalence of known diabetes was 17.4%, unknown diabetes 4.3%, stress hyperglycemia 7.1%, and prediabetes 27.8%. During TPN therapy, 50.9% of patients had at least one capillary blood glucose of >180 mg/dL. Predisposing factors were age, levels of CRP and glycated hemoglobin, the presence of diabetes, infectious complications, the number of grams of carbohydrates infused, and the administration of glucose-elevating drugs. Most (71.6%) patients were treated with insulin. The mean capillary blood glucose levels during TPN were: known diabetes (178.6 ± 46.5 mg/dL), unknown diabetes (173.9 ± 51.9), prediabetes (136.0 ± 25.4), stress hyperglycemia (146.0 ± 29.3), and normal (123.2 ± 19.9) (P<.001). CONCLUSION: The prevalence of carbohydrate metabolism disorders is very high in noncritically ill patients on TPN. These disorders affect insulin treatment and the degree of metabolic control achieved.
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Diabetes Mellitus/epidemiologia , Hiperglicemia/epidemiologia , Insulina/uso terapêutico , Nutrição Parenteral Total/efeitos adversos , Estado Pré-Diabético/epidemiologia , Adulto , Idoso , Glicemia/análise , Diabetes Mellitus/metabolismo , Feminino , Humanos , Hiperglicemia/metabolismo , Masculino , Pessoa de Meia-Idade , Estado Pré-Diabético/metabolismo , Prevalência , Estudos ProspectivosRESUMO
Eating disorders (EDs) manifest as persistent disruptions in eating habits or related behaviors, significantly impacting physical health and psychosocial well-being. Nutritional assessment in ED patients is crucial for monitoring treatment efficacy. While dual-energy X-ray absorptiometry (DEXA) remains standard, interest in alternative methods such as bioelectrical impedance vector analysis (BIVA) and Nutritional Ultrasound® (NU) has risen due to their affordability and portability. Additionally, hand dynamometry offers a user-friendly approach to assessing grip strength (HGS), indicative of nutritional status. A prospective study was carried out to evaluate the utility of BIVA, NU®, and HGS in 43 female AN patients. Measurements were taken at baseline and hospital discharge. A total of 41 patients completed the study. After the intervention, numerous BIVA-related parameters such as fat (3.5 ± 2 kg vs. 5.3 ± 2.7 kg, p < 0.001) and free fat mass (33.9 ± 3.8 kg vs. 37.5 ± 4.1 kg, p < 0.001) were partially restored. Similarly, Nutritional Ultrasound® showed promising results in assessing body composition changes such as total abdominal fat tissue (0.5 ± 0.3 cm vs. 0.9 ± 0.3 cm, p < 0.05). In the same way, rectus femoris cross-sectional area values correlated with clinical outcomes such as free fat mass (0.883, p < 0.05) and appendicular muscle mass (0.965, p < 0.001). HGS reached the normality percentile after the intervention (21.6 ± 9.1 kg vs. 25.9 ± 12.3 kg, p < 0.05), demonstrating a significant association between grip strength and body composition parameters such as free fat mass (0.658, p < 0.001) and appendicular muscle mass (0.482, p < 0.001). Incorporating BIVA-, NU®-, and HGS-enhanced nutritional assessment into the treatment of AN patients offers cost-effective, portable, and non-invasive alternatives to DEXA. These techniques offer valuable insights into changes in body composition and nutritional status, which, in turn, facilitate treatment monitoring and contribute to improved patient outcomes.
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Anorexia Nervosa , Composição Corporal , Impedância Elétrica , Força da Mão , Avaliação Nutricional , Estado Nutricional , Ultrassonografia , Humanos , Feminino , Projetos Piloto , Ultrassonografia/métodos , Estudos Prospectivos , Anorexia Nervosa/fisiopatologia , Anorexia Nervosa/terapia , Adulto , Adulto Jovem , Adolescente , Recuperação de Função FisiológicaRESUMO
Introduction: Bioelectrical impedance analysis (BIA) serves as a method to estimate body composition. Parameters such as phase angle (PA), standardized phase angle (SPA), body mass cell (BCM), BCM index (BCMI), and fat-free mass (FFM) might significantly impact the prognosis of head and neck cancer (HNC) patients. The present study aimed to investigate whether bioelectrical parameters can be used to predict survival in the HNC population and establish the optimal cutoff points for predictive accuracy. Methods: A multicenter observational study was performed across 12 tertiary hospitals in Andalusia (a region from the south of Spain). A total of 494 patients diagnosed with HNC between 2020 and 2022 at different stages were included in this study, with a minimum follow-up period of 12 months. The BIA assessment was carried out during the first 2 weeks of radical radiotherapy treatment with chemotherapy or other systemic treatments. A multivariate logistic regression analysis of overall survival, complications, hospital admission, and palliative care and its relationship with BIA nutritional assessment was performed. Results: Significant prognostic factors identified in the multivariable analysis encompassed phase angle (PA), standardized phase angle (SPA), body cell mass (BCM), and BCM index (BCMI). Lower PA and BCM values were significantly associated with adverse clinical outcomes. A BCM threshold above 17 kg/m2 was the most significant predictor for predicting survival within the overall HNC population. The PA values of <5.1° in male and <4.8° in female patients showed the best predictive potential for mortality. Increased PA (as a continuous variable) demonstrated a significantly reduced risk for mortality (OR, 0.64; 95% CI, 0.43-0.94; p < 0.05) and a decreased likelihood of hospital admission (OR, 0.75; 95% CI, 0.52-1.07; p < 0.05). Higher BCM correlated with a lower risk of mortality (OR, 0.88; 95% CI, 0.80-0.96; p < 0.01) and a diminished probability of hospital admission (OR, 0.91; 95% CI, 0.83-0.99; p < 0.05). Conclusion: BIA is a crucial tool in the nutritional assessment of HNC patients. BCM and PA are the main bioelectrical parameters used to predict clinical outcomes in this population. Future studies are needed to validate BIA variables in a large cohort to ensure whether early intensification of nutritional treatment would improve survival.
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INTRODUCTION: Metabolic dysfunction-associated steatotic liver disease is a major public health problem considering its high prevalence and its strong association with extrahepatic diseases. Implementing strategies based on an intermittent fasting approach and supervised exercise may mitigate the risks. This study aims to investigate the effects of a 12-week time-restricted eating (TRE) intervention combined with a supervised exercise intervention, compared with TRE or supervised exercise alone and with a usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity. METHODS AND ANALYSIS: An anticipated 184 adults with obesity (50% women) will be recruited from Granada (south of Spain) for this parallel-group, randomised controlled trial (TEMPUS). Participants will be randomly designated to usual care, TRE alone, supervised exercise alone or TRE combined with supervised exercise, using a parallel design with a 1:1:1:1 allocation ratio. The TRE and TRE combined with supervised exercise groups will select an 8-hour eating window before the intervention and will maintain it over the intervention. The exercise alone and TRE combined with exercise groups will perform 24 sessions (2 sessions per week+walking intervention) of supervised exercise combining resistance and aerobic high-intensity interval training. All participants will receive nutritional counselling throughout the intervention. The primary outcome is change from baseline to 12 weeks in hepatic fat; secondary outcomes include measures of cardiometabolic health. ETHICS AND DISSEMINATION: This study was approved by Granada Provincial Research Ethics Committee (CEI Granada-0365-N-23). All participants will be asked to provide written informed consent. The findings will be disseminated in scientific journals and at international scientific conferences. TRIAL REGISTRATION NUMBER: NCT05897073.
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Doenças Cardiovasculares , Fígado Gorduroso , Adulto , Feminino , Humanos , Masculino , Exercício Físico , Caminhada , Obesidade/complicações , Obesidade/terapia , Doenças Cardiovasculares/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: It has been suggested that the changes in hormone levels that occur with menopause and aging are related to loss of muscle mass. However, the role of gonadotropins in this process is unknown. OBJECTIVES: To analyze the relationship between follicle-stimulating hormone (FSH) and luteinizing hormone (LH) and lean mass in a cohort of healthy women. METHODS: This is a cross-sectional study including 91 postmenopausal women (48-65 years old). Serum FSH, LH, and estradiol (E2) were measured. Lean mass was estimated by bioelectrical impedance analysis and expressed as appendicular skeletal muscle mass (AMM) index. RESULTS: AMM index was negatively correlated with FSH levels (r = -0.33, p = 0.001) and LH (r = -0.293, p = 0.005), while there was no association with E2. When muscle mass expressed as AMM index was stratified into tertiles, there were significant differences between the lowest and the highest tertile for both FSH (82.4 ± 30, vs. 67.9 ± 25.8 mIU/mL, p = 0.04) and LH (40.9 ± 15.2 vs. 36.1 ± 12.3 mIU/mL, p = 0.03). In logistic regression analysis adjusted for age and E2 levels, high concentrations of FSH (OR = 1.03, 95% CI = 1.01-1.05, p = 0.008) and LH (OR = 1.06, 95% CI = 1.01-1.1, p = 0.01) were risk factors for having lower lean mass expressed as AMM index. CONCLUSIONS: Menopausal women with high levels of gonadotropins have lower levels of lean mass than those with lower gonadotropins levels.
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OBJECTIVE: Metformin modifies the gut microbiome in type 2 diabetes and gastrointestinal tolerance to metformin could be mediated by the gut microbiome. METHODS: We enrolled 35 patients with type 2 diabetes not receiving treatment with metformin due to suspected gastrointestinal intolerance. Metformin was reintroduced at 425 mg, increasing 425 mg every two weeks until reaching 1700 mg per day. According to the occurrence of metformin-related gastrointestinal symptoms, patients were classified into three groups: early intolerance, non-tolerant, and tolerant. Gut microbiota was profiled with 16 S rRNA. This sequencing aimed to determine the differences in the baseline gut microbiota in all groups and prospectively in the tolerant and non-tolerant groups. RESULTS: The classification resulted in 15 early intolerant, 10 tolerant, and 10 non-tolerant subjects. Early tolerance was characterized by a higher abundance of Subdoligranulum; while Veillonella and Serratia were higher in the non-tolerant group. The tolerant group showed enrichment of Megamonas, Megamonas rupellensis, and Phascolarctobacterium spp; Ruminococcus gnavus was lower in the longitudinal analysis. At the end point Prevotellaceae, Prevotella stercorea, Megamonas funiformis, Bacteroides xylanisolvens, and Blautia producta had a higher relative abundance in the tolerant group compared to the non-tolerant group. Subdoligranulum, Ruminococcus torques_1, Phascolarctobacterium faecium, and Eubacterium were higher in the non-tolerant group. The PICRUSt analysis showed a lower activity of the amino acid biosynthesis pathways and a higher sugar degradation pathway in the intolerant groups. CONCLUSIONS: Gut microbiota of subjects with gastrointestinal intolerance depicted taxonomic and functional differences compared to tolerant patients, and this changed differently after metformin administration.
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Diabetes Mellitus Tipo 2/tratamento farmacológico , Microbioma Gastrointestinal/efeitos dos fármacos , Hipoglicemiantes/administração & dosagem , Metformina/administração & dosagem , Idoso , Feminino , Seguimentos , Humanos , Hipoglicemiantes/efeitos adversos , Masculino , Metformina/efeitos adversos , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
OBJECTIVE: To provide practical recommendations for the management of mineral and bone metabolism alterations in pregnancy and lactation. PARTICIPANTS: Members of the Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology and Nutrition. METHODS: Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. A systematic search was carried out in Medline of the available evidence for each pathology. Papers in English with publication date until 29 February 2020 were included. A methodologist resolved the differences that arose during the process of reviewing the literature and formulating recommendations. The recommendations were discussed and approved by all members of the Working Group. CONCLUSIONS: The document establishes practical recommendations based on evidence about the management of mineral and bone metabolism disorders in pregnancy and lactation.
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Doenças Ósseas Metabólicas , Osteoporose , Feminino , Humanos , Lactação , Minerais , Osteoporose/terapia , GravidezRESUMO
SCOPE: To examine the association between milk and dairy products intake and the prevalence of cognitive decline among Spanish individuals at high cardiovascular risk. METHODS AND RESULTS: Cross-sectional analyses are performed on baseline data from 6744 adults (aged 55-75 years old). Intake of milk and dairy products is estimated using a food frequency questionnaire grouped into quartiles. The risk of developing cognitive impairment is based on the Mini-Mental State Examination (MMSE). A higher prevalence of cognitive decline was found in subjects who consumed more grams. Patients with worse MMSE score (10-24) consumed a mean of 395.14 ± 12.21 g, while patients with better MMSE score (27-30) consumed a mean of 341.23 ± 2.73 g (p < 0.05). Those subjects with the lower milk consumption (<220 g/day) had a higher MMSE score (28.35 ± 0.045). Higher intake of fermented dairy products was observed in participants with a lower MMSE score (OR 1.340, p = 0.003). A positive correlation was found between the consumption of whole milk and the MMSE score (r = 0.066, p < 0.001). CONCLUSIONS: These findings suggest that greater consumption of milk and dairy products could be associated with greater cognitive decline according to MMSE. Conversely, consumption of whole-fat milk could be linked with less cognitive impairment in the cross-sectional study.
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Disfunção Cognitiva/etiologia , Laticínios/efeitos adversos , Idoso , Animais , Disfunção Cognitiva/prevenção & controle , Estudos Transversais , Produtos Fermentados do Leite , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , LeiteRESUMO
Osteoporosis is a common chronic disease characterized by a decrease in bone mineral density, impaired bone strength, and an increased risk of fragility fractures. Fragility fractures are associated with significant morbidity, mortality and disability and are a major public health problem worldwide. The influence of nutritional factors on the development and progression of this disease can be significant and is not yet well established. Calcium intake and vitamin D status are considered to be essential for bone metabolism homeostasis. However, some recent studies have questioned the usefulness of calcium and vitamin D supplements in decreasing the risk of fractures. The adequate intake of protein, vegetables and other nutrients is also of interest, and recommendations have been established by expert consensus and clinical practice guidelines. It is important to understand the influence of nutrients not only in isolation but also in the context of a dietary pattern, which is a complex mixture of nutrients. In this review, we evaluate the available scientific evidence for the effects of the main dietary patterns on bone health. Although some dietary patterns seem to have beneficial effects, more studies are needed to fully elucidate the true influence of diet on bone fragility.
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Cálcio da Dieta/administração & dosagem , Dieta/efeitos adversos , Osteoporose/fisiopatologia , Fraturas por Osteoporose/prevenção & controle , Vitamina D/administração & dosagem , Densidade Óssea , Osso e Ossos/metabolismo , Doença Crônica , Dieta Saudável/métodos , Suplementos Nutricionais , Humanos , Estado Nutricional , Osteoporose/complicações , Fraturas por Osteoporose/etiologiaRESUMO
INTRODUCTION: Environmental temperature has been described to affect plasma glucose levels after oral glucose tolerance testing (OGTT). AIMS: We evaluated the relationship between seasons and environmental temperature and gestational diabetes mellitus (GDM) diagnosis and treatment. METHODS: We analyzed data from 2374 women retrospectively. GDM was diagnosed in 473 patients by a 100-g OGTT. OGTT results and needing of insulin therapy were evaluated in relation to seasons and environmental temperature (mean temperature and temperature change) the day of the OGTT and the preceding 14 and 28 days. RESULTS: We found significant seasonal differences in the percentage of GDM: 24.4% in summer vs. 15.6% in autumn (p < 0.01). The odds ratio (OR) for being diagnosed with GDM was 1.78 in summer relative to autumn, after controlling for age. A higher mean temperature the day of the OGTT and the preceding 14 and 28 days increased the risk of being diagnosed with GDM the months in which temperature was rising (March-August) but not the months in which temperature was decreasing (September-February). We observed a negative correlation between temperature and fasting glucose and a positive correlation with post-load glucose. Neither the season nor the environmental temperature affected the risk of requiring insulin therapy. CONCLUSIONS: There is a higher prevalence of GDM diagnosis at warmer seasons and at rising temperatures the 2-4 weeks prior to the OGTT. The impact of temperature is different between fasting and post-load glucose.
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Diabetes Gestacional , Glicemia , Feminino , Teste de Tolerância a Glucose , Humanos , Gravidez , Estudos Retrospectivos , TemperaturaRESUMO
BACKGROUND: Many food items included in the Mediterranean diet (MedDiet) are rich in polyamines, small aliphatic amines with potential cardioprotective effects. The consumption of a MedDiet could increase polyamine concentrations. Based on experimental models, polyamine concentrations may be also influenced by physical activity (PA). OBJECTIVES: We aimed to evaluate whether an intervention based on an energy-restricted MedDiet (er-MedDiet) and PA promotion, in comparison with an energy-unrestricted MedDiet and traditional health care, influences the serum pattern of polyamines and related metabolites in subjects at high risk of cardiovascular disease (CVD). METHODS: This was a substudy from the PREDIMED-Plus trial, an ongoing randomized clinical trial including 6874 participants allocated either to an intensive weight-loss lifestyle intervention based on er-MedDiet, PA promotion, and behavioral support (er-MedDiet + PA group), or to an energy-unrestricted MedDiet and traditional health care group (MedDiet group). A total of 75 patients (n = 38, er-MedDiet + PA group; n = 37, MedDiet group) were included in this study. Serum concentrations of arginine, ornithine, polyamines, and acetyl polyamines at baseline and 26 wk of intervention were measured by an ultra-high-performance LC-tandem MS platform. RESULTS: At week 26, study groups had similar adherence to the MedDiet but patients randomly assigned to the er-MedDiet + PA group showed significantly lower mean energy intake (-340.3 kcal/d; 95% CI: -567.3, -113.4 kcal/d; P = 0.004), higher mean PA (1290.6; 95% CI: 39.9, 2541.3 metabolic equivalent tasks · min/d; P = 0.043), and higher mean decrease in BMI (in kg/m2) (-1.3; 95% CI: -1.8, -0.6; P < 0.001) than the MedDiet group. However, no significant differences in serum polyamines or related metabolites were found between study groups after 26 wk of intervention and no significant between-group differences were found in glycated hemoglobin, HDL-cholesterol, or triglyceride concentrations. CONCLUSIONS: In individuals at high CVD risk, an er-MedDiet with increased PA did not result in significant changes of serum concentrations of polyamines or related metabolites in comparison with an energy-unrestricted MedDiet and no increase in PA. This trial was registered at isrctn.com as ISRCTN89898870.
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Doenças Cardiovasculares/prevenção & controle , Dieta Mediterrânea , Ingestão de Energia , Exercício Físico , Estilo de Vida , Poliaminas/sangue , Idoso , Feminino , Fatores de Risco de Doenças Cardíacas , Humanos , Masculino , Metaboloma , Pessoa de Meia-IdadeRESUMO
OBJECTIVE: To assess the impact of a telemedicine visit using the platform Diabetic compared with a face-to-face visit on clinical outcomes, patients' health-related quality of life (HRQoL), and physicians' satisfaction in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: PLATEDIAN (Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients) (NCT03332472) was a multicenter, randomized, 6-month follow-up, open-label, parallel-group controlled study performed in patients with type 1 diabetes with suboptimal metabolic control (HbA1c <8% [<64 mmol/mol]), treated with multiple daily injections. A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three face-to-face visits (control cohort [CC]) (n = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC]) (n = 163). The primary efficacy end point was the mean change of HbA1c levels from baseline to month 6. Other efficacy and safety end points were mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians' satisfaction. RESULTS: At month 6, the mean change in HbA1c levels was -0.04 ± 0.5% (-0.5 ± 5.8 mmol/mol) in the CC and 0.01 ± 0.6% (0.1 ± 6.0 mmol/mol) in the IC (P = 0.4941). The number of patients who achieved HbA1c <7% (<53 mmol/mol) was 73 and 78 in the CC and IC, respectively. Significant differences were not found regarding safety end points at 6 months. Changes in HRQoL between the first visit and final visit did not differ between cohorts, and, regarding fear of hypoglycemia (FH-15 score ≥28), statistically significant differences observed at baseline remained unchanged at 6 months (P < 0.05). CONCLUSIONS: The use of telemedicine in patients with type 1 diabetes with HbA1c <8% (<64 mmol/mol) provides similar efficacy and safety outcomes as face-to-face visits.
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Diabetes Mellitus Tipo 1/metabolismo , Diabetes Mellitus Tipo 1/terapia , Hemoglobinas Glicadas/metabolismo , Insulina/administração & dosagem , Atenção Primária à Saúde/métodos , Telemedicina , Adulto , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Diabetes Mellitus Tipo 1/tratamento farmacológico , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemiantes/administração & dosagem , Injeções , Masculino , Pessoa de Meia-Idade , Visita a Consultório Médico , Atenção Primária à Saúde/organização & administração , Qualidade de Vida , Espanha , Telemedicina/métodos , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: The hypertriglyceridemic waist (HTGW) phenotype is characterized by abdominal obesity and high levels of triglycerides. In a cross-sectional assessment of PREDIMED-Plus trial participants at baseline, HTGW phenotype prevalence was evaluated, associated risk factors were analyzed, and the lifestyle of individuals with metabolic syndrome and HTGW was examined. METHODS: A total of 6,874 individuals aged 55 to 75 with BMI ≥ 27 and < 40 kg/m2 were included and classified by presence (HTGW+ ) or absence (HTGW- ) of HTGW (waist circumference: men ≥ 102 cm, women ≥ 88 cm; fasting plasma triglycerides ≥ 150 mg/dL). Analytical parameters and lifestyle (energy intake and expenditure) were analyzed. RESULTS: A total of 38.2% of the sample met HTGW+ criteria. HTGW+ individuals tended to be younger, have a greater degree of obesity, be sedentary, and be tobacco users. They had higher peripheral glucose, total cholesterol, and low-density lipoprotein cholesterol levels; had lower high-density lipoprotein cholesterol levels; and had increased prevalence of type 2 diabetes mellitus. Mediterranean diet (MedDiet) adherence and physical activity were greater in HTGW- patients. Age, BMI, tobacco use, total energy expenditure, hypertension, type 2 diabetes mellitus, and MedDiet adherence were associated with HTGW+ . CONCLUSIONS: HTGW is a highly prevalent phenotype in this population associated with younger age, higher BMI, tobacco use, and decreased MedDiet adherence. HTGW- individuals were more physically active with greater total physical activity, and fewer had hypertension.
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Cintura Hipertrigliceridêmica/epidemiologia , Estilo de Vida , Obesidade Abdominal/complicações , Triglicerídeos/sangue , Circunferência da Cintura/fisiologia , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fenótipo , Fatores de RiscoRESUMO
BACKGROUND: Overall quality of dietary carbohydrate intake rather than total carbohydrate intake may determine the risk of cardiovascular disease (CVD). OBJECTIVE: We examined 6- and 12-mo changes in carbohydrate quality index (CQI) and concurrent changes in several CVD risk factors in a multicenter, randomized, primary-prevention trial (PREDIMED-Plus) based on an intensive weight-loss lifestyle intervention program. METHODS: Prospective analysis of 5373 overweight/obese Spanish adults (aged 55-75 y) with metabolic syndrome (MetS). Dietary intake information obtained from a validated 143-item semiquantitative food-frequency questionnaire was used to calculate 6- and 12-mo changes in CQI (categorized in quintiles), based on 4 criteria (total dietary fiber intake, glycemic index, whole grain/total grain ratio, and solid carbohydrate/total carbohydrate ratio). The outcomes were changes in intermediate markers of CVD. RESULTS: During the 12-mo follow-up, the majority of participants improved their CQI by increasing their consumption of fruits, vegetables, legumes, fish, and nuts and decreasing their consumption of refined cereals, added sugars, and sugar-sweetened beverages. After 6 mo, body weight, waist circumference (WC), systolic and diastolic blood pressure (BP), fasting blood glucose, glycated hemoglobin (HbA1c), triglyceride levels, triglycerides and glucose (TyG) index, and TyG-WC decreased across successive quintiles of improvement in the CQI. After 12 mo, improvements were additionally observed for HDL cholesterol and for the ratio of total to HDL cholesterol. Favorable improvements (expressed in common units of SD and 95% CI) for quintile 5 compared with quintile 1 of CQI change were observed for most risk factors, including TyG-WC (SD -0.20; 95% CI -0.26, -0.15), HbA1c (SD -0.16; 95% CI -0.23, -0.10), weight (SD -0.12; 95% CI -0.14, -0.09), systolic BP (SD -0.11; 95% CI -0.19, -0.02) and diastolic BP (SD -0.11; 95% CI -0.19, -0.04). CONCLUSIONS: Improvements in CQI were strongly associated with concurrent favorable CVD risk factor changes maintained over time in overweight/obese adults with MetS. This trial was registered as ISRCTN 89898870.
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Doenças Cardiovasculares/prevenção & controle , Carboidratos da Dieta/administração & dosagem , Sobrepeso , Idoso , Dieta/normas , Carboidratos da Dieta/classificação , Carboidratos da Dieta/normas , Ingestão de Energia , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Inquéritos e QuestionáriosRESUMO
The relationship between vitamin D status, calcium intake and the risk of developing type 2 diabetes (T2D) is a topic of growing interest. One of the most interesting non-skeletal functions of vitamin D is its potential role in glucose homeostasis. This possible association is related to the secretion of insulin by pancreatic beta cells, insulin resistance in different tissues and its influence on systemic inflammation. However, despite multiple observational studies and several meta-analyses that have shown a positive association between circulating 25-hydroxyvitamin D concentrations and the risk of T2D, no randomized clinical trials supplementing with different doses of vitamin D have confirmed this hypothesis definitively. An important question is the identification of what 25-hydroxyvitamin D levels are necessary to influence glycemic homeostasis and the risk of developing T2D. These values of vitamin D can be significantly higher than vitamin D levels required for bone health, but the currently available data do not allow us to answer this question adequately. Furthermore, a large number of observational studies show that dairy consumption is linked to a lower risk of T2D, but the components responsible for this relationship are not well established. Therefore, the importance of calcium intake in the risk of developing T2D has not yet been established. Although there is a biological plausibility linking the status of vitamin D and calcium intake with the risk of T2D, well-designed randomized clinical trials are necessary to answer this important question.
Assuntos
Cálcio/administração & dosagem , Diabetes Mellitus Tipo 2/etiologia , Estado Nutricional/fisiologia , Vitamina D/análogos & derivados , Vitamina D/administração & dosagem , Glicemia/metabolismo , Cálcio/sangue , Homeostase/fisiologia , Humanos , Resistência à Insulina/fisiologia , Células Secretoras de Insulina/metabolismo , Fatores de Risco , Vitamina D/sangue , Deficiência de Vitamina D/complicaçõesRESUMO
Recently, a number of studies have related the development of highly prevalent disorders such as type 2 diabetes and obesity to gut microbiota. Obesity itself have been associated with modifications in gut microbiota composition, and a tendency towards an overgrowth of microorganisms that obtain more efficient energy from diet. It's capacity to decompose the polysaccharides that can not be digested by the host, increase monosaccharide and short chain fatty acid (SCFA) production. However, the increase in fat mass is not only due to a more efficient harvest of energy, but also the microbiota participates in changes in endotoxemia, bowel permeability, insulin resistance, hormonal environment, expression of genes regulating lipogenesis, interaction with bile acids, as well as changes in the proportion of brown adipose tissue, and effects associated with the use of drugs such as metformin. Currently, use of prebiotics and probiotics and other innovative techniques like antibiotic therapy or gut microbiota transplant, has been proposed as suitable tools to control the development of metabolic diseases such as obesity or insulin resistance through the diet.
Assuntos
Diabetes Mellitus Tipo 2 , Microbioma Gastrointestinal , Obesidade , Humanos , MicrobiotaRESUMO
INTRODUCTION: Controlling postprandial glycemia (PPG) is important to achieve optimal glycemic control, but few studies have evaluated how often is measured and evaluated. OBJECTIVES: To evaluate how often patients on insulin therapy measure PPG and modify insulin doses accordantly. As secondary objectives, we evaluated the factors conditioning elevated PPG and associated issues. MATERIAL AND METHODS: Cross-sectional observational study based on a web-based survey from an unselected sample of adult insulin-treated patients. A p-value ofâ¯<â¯0.05 was significant. RESULTS: 1251 patients (68% women, 38.9⯱â¯13â¯years [mean⯱â¯SD], body mass index (BMI) 24.2⯱â¯4.2â¯kg/m2, diabetes duration 17.4⯱â¯12.8â¯years, insulin dose 38⯱â¯18â¯IU) participated, 1104 with autoinmmune disease (AD) and 147 with non-autoinmmune diabetes (NAD). 59% of patients had HbA1câ¯≤â¯7%, 92.7% of patients with AD and 55.8% with NAD were attended by specialists (pâ¯<â¯0.001). People with AD did more often blood glucose monitoring (BGM) (pâ¯<â¯0.0001) and used continuous glucose monitoring systems (CGMS) (pâ¯<â¯0.0001). 90.1% with AD and 68.0% with NAD received instructions on measuring PPG (pâ¯<â¯0.001), and more with AD received specific training to change the treatment (87% vs. 61.2%, pâ¯<â¯0.0001) and were more proactive. However, more with NAD discussed their postprandial glucose levels with their healthcare team during clinical visits (92.5% vs. 74.1%, pâ¯<â¯0.0001). Regarding bolus administration, 88.6% with AD and 68.7% with NAD injected the insulin bolus before meals (pâ¯<â¯0.001). CONCLUSIONS: Patients with AD determine PPG more frequently. Diabetes type, follow-up setting, number of injections and CGMS use were the most important predictive factors for PPG measurement. Diabetes education programs should address how to best monitor PPG and appropriate corrective actions.