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Background Nut consumption has been related to improvements on cardiometabolic parameters and reduction in the severity of atherosclerosis mainly in primary cardiovascular prevention. The objective of this trial is to evaluate the effects of the Brazilian Cardioprotective Diet (DIetaCArdioprotetoraBrasileira, DICA Br) based on consumption of inexpensive locally accessible foods supplemented or not with mixed nuts on cardiometabolic features in patients with previous myocardial infarction (MI). Methods DICA-NUTS study is a national, multicenter, randomized 16-week follow-up clinical trial. Patients over 40 years old with diagnosis of previous MI in the last 2 to 6 months will be recruited (n = 388). A standardized questionnaire will be applied to data collection and blood samples will be obtained. Patients will be allocated in two groups: Group 1: DICA Br supplemented with 30 g/day of mixed nuts (10 g of peanuts, 10 g of cashew, 10 g of Brazil nuts); and Group 2: only DICA Br. The primary outcome will consist of LDL cholesterol means (in mg/dL) after 16 weeks of intervention. Secondary outcomes will consist of other markers of lipid profile, glycemic profile, and anthropometric data. Discussion It is expected that DICA Br supplemented with mixed nuts have superior beneficial effects on cardiometabolic parameters in patients after a MI, when compared to DICA Br. Trial registration ClinicalTrials.gov Identifier NCT03728127. First register: November 1, 2018; Last update: June 16, 2021. World Health Organization Universal Trial Number (WHO-UTN): U1111-1259-8105.

Most of the evidence on bariatric surgery on obstructive sleep apnea (OSA) is based on observational studies and/or short-term follow-up in patients with obesity grade 3. This randomized study compared the effects of roux-en-Y gastric bypass (RYGB) or usual care (UC) on OSA severity in patients with obesity grade 1–2. Mild, moderate, and severe OSA was defined by the apnea-hypopnoea index (AHI): 5–14.9; 15–29.9, and ≥30 events/h, respectively. OSA remission was defined by converting any form of OSA into normal AHI (

Bariatric surgery is an effective strategy for blood pressure (BP) reduction, but most of the evidence relies on office BP measurements. In this study, we evaluated the impact of bariatric surgery on 24-hour BP profile, BP variability, and resistant hypertension prevalence. This is a randomized trial including obese patients with grade 1 and 2 using at least 2 antihypertensive drugs at maximal doses or >2 at moderate doses. Patients were allocated to either Roux-en-Y Gastric Bypass (RYGB) combined with medical therapy or medical therapy alone for 12 months. The primary outcome was the 24-hour BP profile and variability (average real variability of daytime and night time BP). We evaluated the nondipping status and prevalence of resistant hypertension as secondary end points. We included 100 patients (76% female, body mass index, 36.9±2.7 kg/m 2 ). The 24-hour BP profile (including nondipping status) was similar after 12 months, but the RYGB group required less antihypertensive classes as compared to the medical therapy alone (0 [0–1] versus 3 [2.5–4] classes; P P =0.01). Prevalence of resistant hypertension was similar at baseline (RYGB, 10% versus MT, 16%; P =0.38), but it was significantly lower in the RYGB at 12 months (0% versus 14.9%; P Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01784848.

Summary Background & aims To evaluate the effect of the Brazilian Cardioprotective Diet Program (BALANCE Program) on inflammatory biomarkers, involved in the pathophysiology of the atherosclerosis, on inflammatory biomarkers, cardiovascular risk factors, and on plasma fatty acids in cardiovascular disease secondary prevention patients. Methods In this substudy of the BALANCE Program randomized clinical trial, a total of 369 patients aged 45 years or older, who have experienced cardiovascular disease in the previous 10 years, were included. These patients were randomized into two groups and followed up for six months: BALANCE Program group and control group (conventional nutrition advice). In the initial and six-month final visits, anthropometry (body weight, height and waist circumference), food intake evaluation by 24-h dietary recall, plasma inflammatory biomarkers (IL-6, IL-8, IL-10, IL-12, tumor necrosis factor-α, adiponectin, and C-reactive protein levels), blood pressure, glycemia, insulinemia, lipid profile, and plasma fatty acids levels were evaluated. Results The BALANCE Program group showed increased plasma alpha-linolenic acid levels (P = 0.008), reduction in waist circumference (P = 0.049) and BMI (P = 0.032). No difference was observed among plasma inflammatory biomarkers and clinical data. Conclusion After six months of follow-up, BALANCE Program led to a significant reduction on BMI and waist circumference in individuals in secondary prevention for cardiovascular disease. Although plasmatic alpha-linolenic acid has increased, there was no impact on plasma inflammatory biomarkers. Clinical trial registration NCT01620398.

Background: Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the impact of bariatric surgery in patients with obesity and hypertension are needed. Methods: In this randomized, single-center, nonblinded trial, we included patients with hypertension (using ≥2 medications at maximum doses or >2 at moderate doses) and a body mass index between 30.0 and 39.9 kg/m 2 . Patients were randomized to Roux-en-Y gastric bypass plus medical therapy or medical therapy alone. The primary end point was reduction of ≥30% of the total number of antihypertensive medications while maintaining systolic and diastolic blood pressure Results: We included 100 patients (76% female, mean age 43.8±9.2 years, mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up. Reduction of ≥30% of the total number of antihypertensive medications while maintaining controlled blood pressure occurred in 41 of 49 patients from the gastric bypass group (83.7%) compared with 6 of 47 patients (12.8%) from the control group with a rate ratio of 6.6 (95% confidence interval, 3.1–14.0; P P =0.005). Eleven patients (22.4%) from the gastric bypass group and none in the control group were able to achieve SPRINT levels without antihypertensives. Waist circumference, body mass index, fasting plasma glucose, glycohemoglobin, low-density lipoprotein cholesterol, triglycerides, high-sensitivity C-reactive protein, and 10-year Framingham risk score were lower in the gastric bypass than in the control group. Conclusions: Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT01784848.

Background: Bariatric surgery represents an effective strategy for office blood pressure (BP) reduction in obese hypertensive patients. However, no previous study evaluated the impact of bariatric surgery on 24-h BP profile, non-dipping status and incidence of resistant hypertension (RH). Methods: This is a sub-analysis of a randomized clinical trial including hypertensive patients with grade 1 and 2 obesity, aged 18 to 65 years, using at least 2 drugs at optimal doses or >2 at moderate doses. Patients were randomly allocated to either Roux-en-Y Gastric Bypass (RYGB) with medical therapy (MT) or MT alone for 12 months. We analyzed the 24-h BP profile, non-dipping status (defined by Results: A total of 100 patients were included (76% female, age 43.8±9.2 years, BMI 36.9±2.7 Kg/m 2 ). The 24-h BP profile was similar at 12 months in both groups, but the RYGB group required less anti-hypertensive classes compared to the MT alone (Figure). The rate of non-dipping BP did not change significantly during the follow-up (RYGB: from 18/48 (37.5%) to 22/48 (45.8%); p=0.30; MT: from 16/33 (48.5%) to 15/33 (45.5%); p=0.80). In an exploratory analysis, the incidence of RH was similar at the baseline (RYGB 10% (5/50) and MT 16% (8/50); p=0.38). After 12 months, it changed significantly in the RYGB group: 0% (0/49) while remained stable in the MT group: 14.9% (7/47) (p Conclusions: RYGB significantly reduced anti-hypertensive medications while promoting similar 24-h BP profile and non-dipping BP status compared to the MT alone. RYGB may be an attractive strategy to reduce RH incidence in obese patients.

Adipose tissue (AT) metabolism is altered in obese subjects, and the reestablishment of energy homeostasis requires the identification and regulation of genes with altered patterns. The aim of this study was to compare mRNA expression of PPARbeta/delta and PPARgamma1-3 in morbidly obese and nonobese patients. The expression pattern of these receptors in various abdominal adipose tissues, subcutaneous (SAT), retroperitoneal (RAT) and visceral (VAT), was also evaluated.The AT depots were obtained by surgery. Total RNAs were extracted using TRIzol. PPARs reverse transcripts were determined by quantitative polymerase chain reaction (qRT-PCR).The amounts of PPARP/8 mRNA in different depots of morbidly obese AT showed a significant decrease in VAT (P0.05). In the non-obese group, the level of PPARbeta/delta was higher in SAT (P0.05), but PPARgamma1-3 was not differentially expressed in obese and non-obese depots. When comparing obese and non-obese, the results revealed a decrease in PPARPbeta/delta expression in SAT (P = 0.058) and VAT (P = 0.094) of the morbidly obese. PPARgamma1-3 mRNA expression was increased significantly in SAT (P = 0.022) and decreased in RAT (P = 0.034) in morbidly obese subjects. PPARbeta/delta expression in SAT and VAT correlated negatively with hip size and insulin serum respectively. PPARgamma1-3 expression in RAT correlated negatively with waist and hip circumference and in VAT correlated positively with waist size.The present study demonstrates that PPARbeta/delta and PPARgamma1-3 mRNAs are quantitatively different in AT of morbidly obese individuals compared to non-obese, and that PPARbeta/delta mRNA levels are characteristic for each AT depot.

Background: The purpose of this study was to determine the total content of trans fatty acids (TFA) in subcutaneous, retroperitoneal and visceral fat of morbidly obese and non-obese patients submitted to bariatric surgery or plastic and abdominal surgery. Methods: The adipose tissues were obtained by surgery; lipids were extracted, saponified and esterified. TFA were measured by FTIR-ATR spectroscopy. Results: The TFA average in obese patients was 6.3% for retroperitoneal and 8.7% for visceral fat. For non-obese patients, the figures were 6.9% (subcutaneous) and 9.3% (visceral). There was no difference between the groups. However, the TFA depot in visceral fat was higher than other fatty tissues for morbidly obese (P

Introduction: Obesity and overweight are becoming progressively more prevalent worldwide and are independently associated with a significant increase in the risk of cardiovascular diseases. Systemic arterial hypertension is frequently found in association with obesity and contributes significantly to increased cardiovascular risk. We hypothesise that Roux-en-Y gastric bypass (RYGB) surgery, a procedure that effectively reduces body weight, can also positively impact blood pressure control in obese and hypertensive individuals. Methods and analysis: A unicentric, randomised, controlled, unblinded clinical trial. Sixty obese (body mass index between 30 and 39.9) and moderately well controlled hypertensive patients, in use of at least two antihypertensive medications at maximum doses or more than two in moderate doses, will be randomly allocated, using an online, electronic and concealed method, to receive either RYGB plus optimised clinical treatment (OCT) or OCT alone. The primary end point is the reduction of antihypertensive medication at 1 and 2 years of follow-up. Data analysis will primarily be conducted on an intention-to-treat basis. Ethics and dissemination: The study was approved by the local institutional review board that works in total compliance with the latest version of the Helsinki Declaration, the Good Clinical Practices (GCP), the ‘America’s Document’ and the national regulatory laws. Before the beginning of any study-related activities, each study participant is asked to provide a signed informed consent. Trial registration number: NCT01784848.