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In a randomized trial, men 65 years of age or older who had low serum testosterone levels and limitations in mobility were assigned to either placebo or testosterone gel to be applied daily for 6 months. The primary end point was improvement in leg-press strength, which was greater with testosterone therapy than with placebo. However, the trial was stopped early because of a greater number of cardiac adverse events in the testosterone group. In men 65 years of age or older with low serum testosterone levels and limitations in mobility, improvement in leg-press strength was greater with testosterone therapy than with placebo. However, there were more cardiac adverse events in the testosterone group. Limited mobility is a common geriatric condition that is a predictor of disability, poor quality of life, and death. 1 – 7 In men, an age-related decline in the serum testosterone concentration is associated with reduced muscle mass and lower-extremity strength, limitations in physical function, and poor mobility. 8 – 13 Testosterone supplementation increases muscle mass and strength and leg power, all of which are important determinants of mobility. 14 – 21 Previous trials of testosterone supplementation have been conducted primarily among healthy older men. The safety and efficacy of testosterone treatment in improving muscle performance and physical function in older men with limitations in mobility . . .

Evolocumab (AMG 145), a fully human monoclonal antibody against PCSK9, significantly reduced low-density lipoprotein cholesterol (LDL-C) levels in phase 2 and 3 studies. This phase 3 study evaluated the efficacy and safety of evolocumab plus atorvastatin in Japanese patients with hyperlipidemia or mixed dyslipidemia and high cardiovascular risk. Patients were randomized to atorvastatin 5 or 20 mg/day for 4 weeks. Subsequently, patients underwent second randomization to evolocumab 140 mg biweekly (Q2W) or 420 mg monthly (QM) or placebo Q2W or QM. Coprimary end points were % change from baseline in LDL-C at week 12 and mean of weeks 10 and 12. Secondary end points included change and % change in other lipids and proportion of patients reaching LDL-C <70 mg/dl. Adverse events and laboratory values were recorded. Four hundred four patients were randomized to study drug. At baseline, the mean (SD) age was 61 (10) years (placebo) and 62 (11) years (evolocumab); 39% and 40% were women; 14% and 12% had cerebrovascular or peripheral arterial disease; and 51% and 47% had diabetes. At entry, mean (SD) calculated LDL-C was 128 (23) mg/dL; after stabilization on atorvastatin 5 and 20 mg/day, baseline LDL-C levels were 118 (35) and 94 (24) mg/dL, respectively. Mean LDL-C reductions at week 12 for evolocumab versus placebo ranged from 67% to 76%. No imbalances were observed in adverse events between treatment groups. Efficacy and safety for Q2W or QM evolocumab dosing were similar. In conclusion, in high-risk Japanese patients receiving stable statin therapy, evolocumab markedly reduced LDL-C and was well tolerated.

Obesity is characterized by elevated lipids, insulin resistance and relative hypogonadotropic hypogonadism, reducing fertility and increasing risk of pregnancy complications and birth defects. We termed this phenotype 'Reprometabolic Syndrome' and showed that it can be recapitulated by acute infusions of lipid/insulin into healthy, normal weight, eumenorrheic women. Herein, we examined the broader impact of hyperlipidemia and euglycemic hyperinsulinemia on anterior pituitary trophic hormones and their targets. Serum FSH, LH, TSH, growth hormone (GH), prolactin (PRL), thyroid hormones (free T4, total T3), cortisol, IGF-1, adiponectin, leptin and creatinine were measured in a secondary analysis of an interventional crossover study of 12 normal weight cycling women who underwent saline and heparin (control) infusion, or a euglycemic insulin infusion with heparin and Intralipid® (lipid/insulin), between days 2-5 in sequential menstrual cycles. In contrast to the decrease in gonadotropins, FSH and LH, infusion of lipid/insulin had no significant effects on other trophic hormones; TSH, PRL or GH. Thyroid hormones (fT4 and total T3), cortisol, IGF-1, adiponectin and creatinine also did not differ between saline or lipid/insulin infusion conditions. Leptin increased in response to lipid/insulin (p<0.02). Acute hyperlipidemia and hyperinsulinemia exerted differential, cell type specific effects on the hypothalamic-pituitary-gonadal, adrenal and thyroid axes. Elucidation of mechanisms underlying the selective modulation of pituitary trophic hormones, in response to changes in diet and metabolism, may facilitate therapeutic intervention in obesity-related neuroendocrine and reproductive dysfunction.

Despite guideline recommendations to optimize low-density lipoprotein cholesterol (LDL-C) reduction with intensification of lipid-lowering therapy (LLT) in patients with atherosclerotic cardiovascular disease (ASCVD), few of these patients achieve LDL-C < 70 mg/dL in practice. We developed a real-time, targeted electronic health record (EHR) alert with embedded ordering capability to promote intensification of evidence based LLT in outpatients with very high risk ASCVD. We designed a pragmatic, multicenter, single-blind, cluster randomized trial to test the effectiveness of an EHR-based LLT intensification alert. The study will enroll about 100 providers who will be randomized to either receive the alert or undergo usual care for outpatients with high risk ASCVD with LDL-C > 70 mg/dL. Total enrollment will include 2,500 patients. The primary outcome will be the proportion of patients with LLT intensification at 90 days. Secondary outcomes include achieved LDL-C at 6 months and the proportion of patients with LDL-C < 70 mg/dL or < 55 mg/dL at 6 months. Enrollment of 1,250 patients (50% of goal) was reached within 47 days (50% women, mean age 72, median LDL-C 91). At baseline, 71%, 9%, and 3% were on statins, ezetimibe, or proprotein convertase subtilisin/kexin type 9 inhibitors, respectively. PRagmatic Trial of Messaging to Providers about Treatment of HyperLIPIDemia has rapidly reached 50% enrollment of patients with very high risk ASCVD, demonstrating low baseline LLT utilization. This pragmatic, EHR-based trial will determine the effectiveness of a real-time, targeted EHR alert with embedded ordering capability to promote LLT intensification. Findings from this low-cost, widely scalable intervention to improve LDL-C may have important public health implications. clinicaltrials.gov NCT04394715

Regular exercise has well-established health benefits, some of which are mediated through changes in plasma lipoproteins. This study investigated the relative importance of the amount and the intensity of regular exercise in producing changes in plasma lipoproteins. The amount of exercise per week proved to have a greater effect on lipoproteins than did the intensity of exercise. The amount of exercise had a greater effect on lipoproteins than the intensity of exercise. Increased physical activity and fitness are clearly associated with reductions in the risk of cardiovascular disease, 1 – 5 but the optimal intensity or amount of exercise necessary for reductions in risk or risk factors is unknown. Because of apparently conflicting information, 1 – 3 there is confusion about what recommendations to make for exercise that will confer specific health benefits. In spite of the importance of this issue, there have been no prospective studies investigating the effects of different amounts and intensities of exercise. Although regular exercise is known to decrease the risk of cardiovascular disease, comprehensive reviews 6 , 7 suggest that exercise has . . .

Objective To evaluate the effectiveness of integrated care for chronic physical diseases and depression in reducing disability and improving quality of life.Design A randomised controlled trial of multi-condition collaborative care for depression and poorly controlled diabetes and/or risk factors for coronary heart disease compared with usual care among middle aged and elderly people Setting Fourteen primary care clinics in Seattle, Washington.Participants Patients with diabetes or coronary heart disease, or both, and blood pressure above 140/90 mm Hg, low density lipoprotein concentration >3.37 mmol/L, or glycated haemoglobin 8.5% or higher, and PHQ-9 depression scores of ≥10. Intervention A 12 month intervention to improve depression, glycaemic control, blood pressure, and lipid control by integrating a “treat to target” programme for diabetes and risk factors for coronary heart disease with collaborative care for depression. The intervention combined self management support, monitoring of disease control, and pharmacotherapy to control depression, hyperglycaemia, hypertension, and hyperlipidaemia.Main outcome measures Social role disability (Sheehan disability scale), global quality of life rating, and World Health Organization disability assessment schedule (WHODAS-2) scales to measure disabilities in activities of daily living (mobility, self care, household maintenance).Results Of 214 patients enrolled (106 intervention and 108 usual care), disability and quality of life measures were obtained for 97 intervention patients at six months (92%) and 92 at 12 months (87%), and for 96 usual care patients at six months (89%) and 92 at 12 months (85%). Improvements from baseline on the Sheehan disability scale (−0.9, 95% confidence interval −1.5 to −0.2; P=0.006) and global quality of life rating (0.7, 0.2 to 1.2; P=0.005) were significantly greater at six and 12 months in patients in the intervention group. There was a trend toward greater improvement in disabilities in activities of daily living (−1.5, −3.3 to 0.4; P=0.10).Conclusions Integrated care that covers chronic physical disease and comorbid depression can reduce social role disability and enhance global quality of life.Trial registration Clinical Trials NCT00468676.

Background: The role of herbal medicine is now well documented in preventing and controlling diabetes mellitus. The main aim of this study was to evaluate the effects of walnut oil consumption on lipid profiles of hyperlipidemic patients with type 2 diabetes. Methods: In a randomized, double-blind, placebo-controlled clinical trial, 100 hyperlipidemic type 2 diabetic patients aged 35–75 years were assigned to receive 15 cc Persian walnut oil or placebo every day for 90 days. The primary outcomes were the lipid profiles. Results: Consumption of walnut oil by type 2 hyperlipidemic diabetic patients resulted in a significant decrease in total cholesterol levels (treatment difference (TD)=−30.04, P <0.001), triglyceride (TG) level (TD=−15.04, P =0.021), low-density lipoprotein (LDL) level (TD=−30.44, P <0.001) and total cholesterol to high-density lipoprotein (HDL) ratio (TD=−0.72, P <0.001) compared to the control group. There was a trend toward increasing HDL level with consumption of walnut oil (TD=2.28, P =0.06). Frequency of patients reaching a LDL level below 100 was higher in the case group (20 vs 0%). Conclusions: Addition of walnut oil in the daily diet of type 2 diabetic patients improves lipid profiles. Thus, it may be associated with a coronary artery disease risk factor modulation. Also, walnut oil may serve as a helpful natural remedy for hyperlipidemic patients with type 2 diabetes.

IntroductionMiddle-aged adults with chronic conditions including diabetes, hyperlipidaemia and hypertension are at higher risk for cognitive decline. However, there is a lack of a targeted solution for this population. This study aims to develop a digital solution for salutogenic brain health targeting this population, assess its clinical effectiveness and evaluate the implementation in primary care settings by local champions, that is, nurses.Methods and analysisA type-I hybrid effectiveness-implementation design with a sequential multiple-assignment randomised trial will be adopted. 160 adults aged 40–64 years old with chronic conditions hypertension, hyperlipidaemia and type-II diabetes will be recruited from three National University Polyclinics in Singapore. They will be randomised using block randomisation to either the intervention group (‘Digital solution for Salutogenic Brain health’ programme) or the waitlist control group. Cognitive tests, clinical measures, questionnaires and interviews will be used to evaluate outcome measures. The Reach, Effectiveness, Adoption, Implementation, Maintenance framework and the Capability, Opportunity, Motivation and Behaviour model will be employed to evaluate clinical effectiveness and implementation strategies.Ethics and disseminationThis study has been reviewed and approved by the National Healthcare Group Domain Specific Review Board (NHG DSRB) in Singapore (NHG DSRB Reference Number: 2023/00620 (25 June 2024)). Data will be analysed by study team members and findings will be published in peer-reviewed journals.Trial registration number NCT06582316.

This study aims to investigate the impact of patient-centered health education on individuals with type 2 diabetes coexisting with hyperlipidemia. A cohort of 80 patients with type 2 diabetes and hyperlipidemia attending our hospital from February 2022 to August 2022 were randomly assigned to either the health education group or the control group. While the control group received routine health education, the health education group received additional patient-centered health education. Subsequently, we compared blood glucose and lipid levels, negative emotions, quality of life, and the incidence of unhealthy eating or overweight between the two groups post-education. Following the health education intervention, the health education group exhibited superior improvements in blood glucose and lipid levels compared to the control group. Moreover, there was a significant decrease in SAS and SDS scores and a notable increase in quality of life compared to the control group. The health education group also demonstrated a lower incidence of unhealthy eating or overweight. Patient-centered health education for individuals with type 2 diabetes and hyperlipidemia proves effective in enhancing glucose and lipid metabolism, mitigating negative emotions, improving quality of life, and reducing unhealthy habits.

Purpose Almond consumption is associated with ameliorations in obesity, hyperlipidemia, hypertension, and hyperglycemia. The hypothesis of this 12-week randomized, crossover, controlled feeding trial was that almond consumption would ameliorate inflammation and oxidative stress in Chinese patients with type 2 diabetes mellitus (T2DM) (9 M, 11 F; 58 years; BMI: 26 kg/m 2 ) with mild hyperlipidemia. Methods After a 2-week run-in period, the patients were assigned to either a control NCEP step II diet (control diet) or almond diet for 4 weeks with a 2-week washout period between alternative diets. Almonds approximately at 56 g/day were added to the control diet to replace 20 % of total daily calorie intake. Results As compared to the control diet, the almond diet decreased IL-6 by a median 10.3 % (95 % confidence intervals 5.2, 12.6 %), CRP by a median 10.3 % (−24.1, 40.5), and TNF-α by a median 15.7 % (−0.3, 29.9). The almond diet also decreased plasma protein carbonyl by a median 28.2 % (4.7, 38.2) as compared to the C diet but did not alter plasma malondialdehyde. The A diet enhanced the resistance of LDL against Cu 2+ -induced oxidation by a median 16.3 % (7.4, 44.3) as compared to the C diet. Serum intercellular adhesion molecule-1 and vascular adhesion molecule-1 were not changed by both diets. Conclusions Our results suggested that incorporation of almonds into a healthy diet could ameliorate inflammation and oxidative stress in patients with T2DM.