Hyperlipidemia

Researchers are investigating whether a multifactorial lifestyle intervention involving a Mediterranean diet with reduced calories and increased physical activity can help middle-aged adults (30-50 years) with metabolic syndrome lose weight and maintain that weight loss over time. The study also aims to understand the social and demographic challenges people face in sticking to these healthy habits and to examine the lifestyle patterns of this group. Participants will be randomly assigned to one of two groups. One group will follow general lifestyle recommendations from primary healthcare providers, while the other will receive an intensive program that includes monthly individual and group sessions over 6 months to encourage a Mediterranean diet with 25% fewer calories and physical activity based on WHO guidelines. The goal for the intervention group is to reduce their initial weight by 5-10% within 6 months and maintain this loss after 12 months. Throughout the study, participants will undergo assessments including measurements of weight, waist size, blood sugar, triglycerides, and glycated hemoglobin to monitor changes in their health. Data on demographics, diet, clinical parameters, and laboratory tests will be collected. After the 6-month intervention, a follow-up at 12 months will evaluate how well participants maintain their lifestyle changes. The study emphasizes tracking adherence and identifying factors that help or hinder long-term weight loss maintenance.

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.

This research investigates the relationship between serum levels of statins and SGLT2 inhibitors (SGLT2i) when used together in patients with ischemic heart failure. The study aims to understand how these drugs affect cholesterol, LDL, HDL, and triglyceride levels over time. Conducted by Fayoum University's Department of Cardiology, this prospective study involves 90 outpatient participants diagnosed with ischemic heart disease. Participants are divided into three groups of 30 each: one group takes statins, another takes SGLT2i, and the third group takes both medications. Blood samples are collected at the start and after three months to measure serum statin and plasma SGLT2i levels using high-performance liquid chromatography (HPLC). Researchers monitor the impact of each drug on the other and track changes in lipid profiles and any adverse effects. During the study, patients provide informed consent and attend scheduled visits for blood sampling and laboratory tests. The main outcome is to evaluate the combined effect of statin and SGLT2i therapy on ischemic heart disease after three months. Safety and side effects are also observed. The study spans from April to July 2024, ensuring detailed monitoring of participants' responses to the treatments.

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 evaluating the effectiveness of a six-month virtually-delivered dietary education program called PEDALL to prevent overweight and obesity during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL). The study focuses on English and Spanish speaking families and considers key genetic and sociodemographic risk factors that may affect weight gain during treatment. Participants will be randomly assigned to one of two groups: the PEDALL intervention group or the standard of care (SOC) group. The PEDALL group will receive 26 contact hours of specialized nutrition education through weekly one-hour virtual sessions over six months. The SOC group will receive printed educational materials and nutritional care according to their institution's usual practices. During the study, participants and their caregivers will engage in nutrition education and counseling sessions. Researchers will assess weight status, body mass index trajectories, lifestyle behaviors, and the influence of genetic and sociodemographic factors over time. The main goal is to prevent unhealthy weight gain during maintenance chemotherapy and improve long-term health outcomes for childhood ALL survivors. The study will last up to 3.5 years for primary outcomes, with additional follow-up extending to four years.

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called "diabesity," a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index (BMI) and diabetes or glucose intolerance status. Groups include individuals with BMI ≥ 35 kg/m2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kg/m2 and BMI between 27 and 35 kg/m2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

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 evaluating the safety, tolerability, and how the body processes Semaglutide Nasal Spray compared to a placebo and a known injection in adults who are overweight or obese. This Phase I clinical trial aims to better understand the effects of the nasal spray formulation of Semaglutide in this population. The study is sponsored by Shanghai World Leader Pharmaceutical Co., Ltd. and focuses on adults aged 18 to 65 years with specific body mass index ranges. Participants will receive either the Semaglutide Nasal Spray, placebo, or a Semaglutide injection (Wegovy®) in different randomized groups. The study involves a single-dose administration and includes several cohorts receiving various combinations of the nasal spray and placebo or the injection. Treatments are given once, and the study monitors the participants for up to 36 days after administration to assess drug levels and effects. During the study, participants will undergo various evaluations including blood tests, vital signs monitoring, physical examinations, electrocardiograms (ECGs), and urine analyses from Day 1 to Day 36. Researchers will measure how much of the drug reaches the blood, how long it stays, and any side effects that occur. Antibody levels against the drug will also be checked up to Day 29. Participants will be closely monitored for any safety concerns throughout the study period.