Lipid Metabolism Disorder

Noncommunicable diseases like type 2 diabetes and cardiovascular disease cause more deaths worldwide than any other conditions, with a growing impact especially in low- and middle-income countries. Cardiovascular disease (CVD) is a leading cause of death globally, and its prevalence is rising despite awareness efforts. Diet and nutrition are important factors influencing these diseases, and this research explores the role of a traditional Chinese medicine nutritional drink in supporting cardiovascular health. The study evaluates the effects of the "Perfect Heartio" drink, a nutritional supplement made from diluted herbal extracts traditionally used in Chinese medicine. Participants will consume 15 grams of the drink twice daily for 12 weeks while their compliance is monitored. This intervention is being studied to assess its potential in improving heart and blood vessel function by measuring various cardiovascular health indicators. Participants will be assessed at the start and at weeks 4, 8, and 12 for lipid profiles, heart inflammation, heart injury, and heart remodeling. Quality of life and self-perceived health status will also be evaluated over these timepoints. The study includes healthy adults aged 18 and above who agree to follow the intervention plan and attend follow-up visits. Monitoring throughout the study will help researchers understand the drink's impact on cardiovascular health markers over the 12-week period.

Researchers are evaluating an AI-assisted digital health tool called the "Smart family doctor" to improve control of hypertension, diabetes, and dyslipidemia in adults who have undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). This study uses a randomized controlled design involving about 536 participants across 5-10 hospitals. Participants must be adults aged 18 or older with a history of CABG or PCI and the specified conditions. Participants in the experimental group will use the AI-assisted "Smart family doctor" app that provides personalized health education, targeted guidance on managing blood pressure, blood sugar, medication adherence, exercise, and smoking cessation. They will also receive tailored reminders and can report self-measured health data for feedback. Both groups receive weekly 3-hour health management guidance from health managers, and participants will wear a smart band daily for health data collection during the 6-month study period. Throughout the study, participants will be assessed for control rates of hypertension, diabetes, and hyperlipidemia at 6 months. Additional measures include blood pressure, cholesterol levels, blood glucose, physical activity, quality of life, psychological status, and cognitive function. The study monitors health data continuously via smart bands and collects self-reports and clinical assessments to evaluate the intervention's impact over the 6 months.

Researchers are evaluating the PILI 'Aina project to improve the management of common diet-related cardiometabolic diseases like type 2 diabetes, hypertension, dyslipidemias, and obesity among Native Hawaiian adults. This project aims to reduce risk factors for new diet-related illnesses by promoting traditional Native Hawaiian diets and improving social cohesion. The study focuses on adapting and testing an evidence-based multilevel intervention called PILI 'Aina to optimize its effectiveness and sustainability. The study involves a community-level component called 'Ai Pono, which includes quarterly hands-on cooking demonstrations and cultural lessons held over five years, for a total of 36 events. Each 2-hour event features cooking demonstrations, tastings, and education about the cultural importance of traditional foods like sweet potato, breadfruit, and kalo. These lessons aim to improve family and community eating environments and social cohesion. Attendance is limited to 30 people per event, with priority given to new participants after the first lesson. Participants will be surveyed at each event to assess their reactions, fruit and vegetable intake, confidence in healthy eating, and feelings of community support. Additionally, random samples of households in participating homesteads will be surveyed annually to measure family environment, nutrition environment, social cohesion, diet self-efficacy, food literacy, and social support. These assessments will occur at baseline and yearly for four years, helping researchers evaluate the impact and sustainability of the intervention over time.

Researchers are evaluating the effects of 2-Hydroxybenzylamine (2-HOBA) on patients with heterozygous Familial Hypercholesterolemia (FH). The study aims to test whether 2-HOBA can reduce harmful modifications to HDL and LDL cholesterol and improve HDL function in these individuals. This is a Phase 2 clinical trial sponsored by Vanderbilt University Medical Center. Participants will be randomly assigned to receive either 2-HOBA or a placebo. Those in the treatment group will take 750 mg of 2-HOBA daily, divided into three doses of 250 mg each, for a total of 6 weeks. The placebo group will take matching placebo tablets with the same dosing schedule. Both treatments are taken by mouth three times a day. During the study, participants will undergo assessments to measure changes in HDL cholesterol efflux capacity from baseline to week 6, along with evaluations of modifications in HDL by specific biochemical markers. The trial includes monitoring for safety and efficacy throughout the treatment period, which lasts 6 weeks. This study does not include healthy volunteers, and participant involvement is carefully tracked to assess the impact of the investigational drug on cholesterol function.

Researchers are studying a medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C) in people with high cholesterol. This trial aims to learn if enlicitide given with rosuvastatin, a standard cholesterol-lowering treatment, works better than a placebo. The study is a phase 3, randomized, double-blind, placebo-controlled trial evaluating the combination's effect on LDL-C levels in adults with hyperlipidemia. Participants will be assigned to one of four groups: enlicitide with a placebo matching rosuvastatin, enlicitide with rosuvastatin, rosuvastatin with a placebo matching enlicitide, or placebos for both drugs. All treatments are taken orally once daily for up to 12 weeks. This setup helps researchers compare the effects of enlicitide alone, rosuvastatin alone, their combination, and placebo. During the study, participants will have their LDL-C levels measured at baseline and at weeks 8 and 12. Researchers will also monitor apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein(a), and adverse events. The main outcome is the percent change in LDL-C at week 8. Safety and tolerability are assessed throughout the treatment and up to about 20 weeks. The total participation duration is up to 12 weeks of treatment with follow-up monitoring.

Researchers are conducting a Phase III clinical trial to study the effects of Bempedoic Acid Tablets in adults with primary hyperlipidemia whose condition is not adequately controlled by statins. The study aims to assess the drug's effectiveness, tolerability, and safety in this patient group. It is sponsored by Gan & Lee Pharmaceuticals and involves a randomized, double-blind design to compare treatments. Participants will be randomly assigned to receive either the Bempedoic Acid Tablet or a placebo, both administered once daily by mouth. The treatment period focuses on a 12-week timeframe to evaluate changes in cholesterol levels. The study includes assessments of LDL-C and total cholesterol levels as key measures, alongside monitoring for any adverse events throughout the trial. During the study, participants will undergo evaluations at baseline and at week 12 to measure cholesterol changes. Safety will be monitored through reports of adverse and serious adverse events up to week 13. The trial requires informed consent and adherence to contraception guidelines for participants of reproductive potential. The total participation length spans at least 13 weeks, including treatment and safety follow-up.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are evaluating the effects of Diaberine, a berberine-based nutraceutical, on blood sugar regulation and metabolism in adults with metabolism disorder. This randomized, triple-blind, placebo-controlled trial will study 80 participants aged 18 to 70 over 24 weeks to assess how well this dietary supplement may aid in these health areas. Participants will be randomly assigned to one of two groups. One group will take Diaberine capsules containing Vitamin B12, berberine, magnesium citrate, cinnamon bark extract, chromium, and other ingredients three times daily, 15 minutes before meals. The other group will take placebo capsules with similar appearance but without the active ingredients. Both treatments will continue for 24 weeks with regular monitoring. During the study, participants will have their blood sugar regulation and metabolism measured at baseline, week 12, and week 24. Additionally, quality of life and weight changes will be tracked at multiple points throughout the 24 weeks. Participants will be monitored through questionnaires, blood tests, and weight assessments to evaluate the supplement's effects and tolerance over time.

This research aims to evaluate the effects of EDP167, a small interfering RNA drug targeting the angiopoietin-like 3 protein (ANGPTL3), in adults with Homozygous Familial Hypercholesterolemia (HoFH), a genetic condition causing very high cholesterol levels. By inhibiting ANGPTL3, EDP167 may help manage lipid levels in these patients. The study is a phase II, dose-exploration trial designed to assess the drug's safety, effectiveness, and how it behaves in the body (pharmacokinetics and pharmacodynamics). Participants will be randomly assigned to receive either 200 mg or 300 mg doses of EDP167 through subcutaneous injections. The main study phase includes a screening period and 24 weeks of treatment, with injections given on Day 1 and Week 12. After this, those who complete the main phase may enter a 6-month extension phase receiving injections at Month 0 and Month 3, followed by a 6-month follow-up to further monitor effects and safety. Throughout the study, participants will have their cholesterol levels and other lipid markers regularly measured, including LDL-C, triglycerides, total cholesterol, and ANGPTL3 levels. Safety and immune response to the drug will also be assessed. Participants are monitored to observe changes from baseline up to 6 months after treatment during the extension phase. The total participation duration includes initial screening, treatment periods, and follow-up visits to evaluate both short- and longer-term study outcomes.

Researchers are studying the effects of MAR001 on adults with high triglycerides and remnant cholesterol. This phase 2, randomized, double-blind, placebo-controlled trial aims to compare MAR001 with a placebo to see how it changes triglyceride levels after eating a mixed meal. The study focuses on the postprandial (after eating) state in adults aged 18 to 75 years with elevated triglycerides and remnant cholesterol. Participants receive either MAR001 or a matching placebo through subcutaneous injections. The treatment period lasts 12 weeks, during which researchers measure changes in triglycerides and remnant cholesterol levels after a mixed meal. The study uses a quadruple-blind design, meaning participants, care providers, investigators, and outcomes assessors do not know who receives MAR001 or placebo. During the study, participants will have fasting triglyceride tests at screening and regular assessments throughout the 12 weeks. Researchers will track the area under the curve and peak plasma concentrations of triglycerides and remnant cholesterol after meals to evaluate treatment effects. Participants must maintain stable diets and medication regimens during the trial. Safety and adherence will be monitored with ongoing assessments to understand the impact of MAR001 compared to placebo.