Benefits of water intake on kidney function in older adults: protocol for a randomized controlled trial / Benefícios da ingestão de água na função renal de idosos: protocolo para um estudo clínico randomizado controlado

Objective: The goal of this study is to evaluate the benefits of an increase in water intake guided by a mathematical formula (per kg of body weight) on kidney function in older adults. Methods: Older adults (≥ 65 years old) cared for at the Internal Medicine Unit of a tertiary hospital will be randomized to receive or not guidance on water intake (30 mL/kg per day) after initial assessment of kidney function. After 14 days, participants will be reevaluated through clinical and laboratory examinations. Patients with uncompensated disease will be excluded. The main outcomes will be glomerular filtration rate and laboratory measures such as serum and urinary osmolality, sodium, urea, 24-h urine volume and serum creatinine, uric acid, and copeptin. The Mini Nutritional Assessment (MNA) questionnaire will be applied to participants at each visit. Categorical variables will be described as numbers of cases (%) and compared using the χ2 test whereas continuous variables will be analyzed with Student's t-test in relation to baseline measures. The Generalized Estimating Equations (GEE) method will be performed to assess differences over time and between groups. This study was approved by the Institution's Research Ethics Committee (grant number 16-0153) and is in accordance with the Declaration of Helsinki. Expected Results:By increasing water intake (ml/Kg) we expect to provide an improvement in kidney function in older population assessed by serum creatinine and cystatin-c applied to eGFR formulas. Relevance:Many conditions, both organic and behavioral, can contribute to chronic dehydration states in older adults. To mention, decreased ability to concentrate urine, reduced kidney mass, blood flow, and glomerular filtration rate (GFR) along with changes in sensitivity to hormones such as renin, vasopressin and natriuretic peptide can generate water imbalance, leading to dehydration. For being simple and inexpensive, this strategy may be broadly used and bring several health benefits to older adults.

Objetivo: O objetivo deste estudo é avaliar os benefícios de um aumento da ingestão de água guiado por uma fórmula matemática (por kg de massa corporal) na função renal de idosos. Metodologia:Idosos (≥ 65 anos) atendidos pelo Serviço de Clínica Médica de um hospital terciário foram randomizados para receber ou não orientação sobre o consumo de água (30 mL/kg por dia) após uma avaliação inicial da função renal. Após 14 dias, os participantes serão reavaliados através de exames clínicos e laboratoriais. Pacientes com doença descompensada serão excluídos. Os desfechos principais são a taxa de filtração glomerular e medidas laboratoriais como osmolaridade, sódio e ureia séricos e urinários, volume de urina de 24 horas e creatinina, ácido úrico e copeptina séricos. A Mini Avaliação Nutricional (MNA) será aplicada aos participantes a cada consulta. Variáveis categóricas serão descritas como números de casos (%) e comparadas usando o teste χ2 , enquanto variáveis contínuas serão analisadas com o teste t de Student em relação às medidas iniciais. O método de Equações de Estimativas Generalizadas (GEE) será usado para avaliar diferenças ao longo do tempo e entre grupos. Este estudo foi aprovado pelo Comitê de Ética em Pesquisa da nossa Instituição (processo número 16-0153) e está de acordo com a Declaração de Helsinki. Resultados esperados:Ao aumentar a ingestão de água (ml/Kg) esperamos proporcionar uma melhora na função renal na população idosa avaliada pela creatinina sérica e cistatina-c aplicada às fórmulas de eGFR. Relevância:Muitas condições, tanto orgânicas quanto comportamentais, podem contribuir para estados de desidratação crônica em idosos. Vale mencionar que a diminuição da capacidade de concentração da urina, redução da massa renal, fluxo sanguíneo e taxa de filtração glomerular (TFG) juntamente com alterações na sensibilidade a hormônios como renina, vasopressina e peptídeo natriurético podem gerar desequilíbrio hídrico, levando à desidratação. Por ser simples e de baixo custo, essa estratégia pode ser amplamente utilizada e trazer diversos benefícios à saúde dos idosos.

All-cause mortality and cardiovascular safety of basal insulin treatment in patients with type 2 diabetes mellitus: A systematic review with meta-analysis and trial sequential analysis.

AIM: To evaluate the risk of all-cause and cardiovascular mortality, acute myocardial infarction, and stroke associated with insulin treatment in patients with type 2 diabetes. METHODS: A systematic review with meta-analysis of randomized clinical trials (RCTs) was performed. EMBASE, Cochrane, and PubMed databases were searched for RCTs reporting mortality or cardiovascular events and comparing basal insulin to any treatment in patients with type 2 diabetes. Data were summarized with Mantel-Haenzel relative risk (RR). Trial sequential analysis (TSA) was used to evaluate the reliability of the results considering a 20% relative risk difference between treatments. PROSPERO Registry: CRD42018087336. RESULTS: In total, 2351 references were identified, and 26 studies (24348 patients) were included. Most studies evaluated glargine insulin (69%), compared insulin to GLP-1 analogs (57%), and evaluated add-on therapy with metformin (77%). Insulin was not associated with increased all-cause mortality (RR 0.99; 95% confidence interval (CI) 0.92-1.06), cardiovascular mortality (RR 1.01; 95% CI 0.91-1.13), myocardial infarction (RR 1.02; 95% CI 0.92-1.15), or stroke (RR 0.87; 95% CI 0.68-1.12). Insulin treatment increased severe hypoglycemia risk (RR 2.98; 95% CI 2.47-3.61). All analyses had low statistical heterogeneity. TSA confirmed these findings: optimal sample size (myocardial infarction), futility boundary (all-cause mortality, cardiovascular mortality, and stroke) and harm boundary (hypoglycemia) were reached. CONCLUSION: Treatment with basal insulin of patients with type 2 diabetes does not increase the risk of cardiovascular events or death. Despite the increased risk of hypoglycemia, these findings reinforce that insulin is a safe option in the treatment of type 2 diabetes.

Effects of Diet after Early Breast Cancer Treatment: A Systematic Review and Meta-Analysis of Clinical Trials.

PURPOSE: Randomized clinical trials (RCT) are inconclusive regarding the role of dietary interventions in anthropometric measurements and survival in breast cancer patients. Our aim was to conduct a systematic review and meta-analysis to assess the effects of diet on these outcomes in women treated for early-stage breast cancer. METHODS: Embase, MEDLINE, the Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials were searched for RCT comparing dietary interventions (individualized dietary counseling, prescription of a specific diet, or others) with usual care in women that were treated for early breast cancer. Primary outcomes were overall survival (OS) and disease-free survival (DFS); secondary outcome was a change in body mass index (BMI). RESULTS: We found 12 RCT eligible for analysis, 7 of which were included in the quantitative analysis. Two studies reported OS and DFS and 6 reported BMI data. The hazard ratio (HR) for OS and DFS was 0.91 (95% confidence interval [CI] 0.77-1.07, p = 0.25) and 0.92 (95% CI 0.79-1.08, p = 0.31) for the intervention and control groups, respectively. Intervention was associated with BMI reduction in subjects who received a specific diet instead of counseling or other types of intervention (-0.67; 95% CI -1.14 to -0.21). CONCLUSIONS: Despite increasing survival among breast cancer patients due to better oncological treatments, there is still a lack of prospective data regarding the effects of dietary interventions in this population. We found positive association between prescription of specific diets in terms of anthropometric measures; there were no differences in OS or DFS.