Active clinical trials for "Dyslipidemias"

Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.

The purpose of this study is to evaluate the efficacy and safety of Berlim 25/10 association in the treatment of type 2 diabetes mellitus and dyslipidemia.

This is an implementation type II hybrid study with randomisation in cluster, whose objective is to compare two strategies of implementation of the Brazilian cardioprotective diet guidelines in primary health care in two Brazilian cities. All health professionals from the health units (clusters) randomized to the intervention group will receive training on the subject. The health professionals from the health units randomized to the control group will follow the usual activities, receiving only the printed guidelines, as usually done. After 6 months, the prescription rate of the Brazilian cardioprotective diet will be evaluated, as well as the quality of the diet of patients in both groups.

This pragmatic randomized controlled trial (RCT) with 272 patients with hypercholesterolemia aims to investigate the effectiveness of lipodia, an unguided digital health intervention for patients with hypercholesterolemia on plasma lipid levels and other clinical variables. Inclusion criteria are: age ≥ 18 years, presence of hypercholesterolemia, low-density lipoprotein cholesterol (LDL-C) levels above the risk-adapted target, stability of potential drug treatments for at least four weeks, and stability of potential hormonal treatment for at least 6 months, next to provision of informed consent and sufficient knowledge of the German language. Exclusion criteria are plans to change potential drug treatment in the upcoming 6 months, the presence of homozygous familial hypercholesterolemia (FH) or type III hyperlipidemia, receiving plasmapheresis, Lp(a) > 50 mg/dL, triglyceride (TG) above 400 mg/dL, current pregnancy, planned major operations, liver dysfunction, end-stage renal failure, and other systemic diseases that might interfere with successful study participation. Patients will be randomized and allocated to either an intervention group, in which they will receive access to lipodia in addition to treatment as usual (TAU), or to a control group, in which they will receive only TAU. The primary endpoint will be a change in plasma LDL-C levels, with six months post-allocation (T2) being the primary timepoint for assessment of effectiveness. Three months post-allocation (T1) will serve as early-response assessment of endpoints. Secondary endpoints will be patient activation, the change in levels of other plasma lipids (non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL), TG), responder rate of LDL-C, self-reported health-related quality of life, and BMI.

A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).

This observation study is to evaluate blood lipid-lowering effects and liver/renal safety, changes in HbA1c and FPG in patients with dyslipidemia who administered CREZET tablets for 24 weeks.

This study has 3 aims. Aim 1: Identify social determinants of cardiometabolic health and determine facilitators and modifiable barriers in achieving treatment goals. Aim 2: Assess PLWH knowledge, skills, and confidence for self-management of cardiometabolic disorders. Aim 3: Tailor a self-management support and education intervention with stakeholder input to address barriers to achieving treatment goals for cardiometabolic disorders in PLWH at the study sites.

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386(5)

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia. In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.

The goal of this project is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk.