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Hypercholesterolemia clinical trials

View clinical trials related to Hypercholesterolemia.

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NCT ID: NCT06247137 Completed - Clinical trials for Hypercholesterolemia

Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Several controlled interventional studies have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in serum levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C), obtained through lifestyle modification or specific drugs, result in reductions in the incidence of major coronary events. The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in subjects in secondary prevention. Based on this evidence, the National Cholesterol Education Program (NCEP) has defined in the ATP III report the target values of LDL-C to be reached with interventions on food and / or pharmacological habits to perform an effective cardiovascular prevention. Although the atherogenic action of hypercholesterolemia is largely attributable to a direct damage exerted on vascular endothelium, recent studies suggest that the activation of a low-grade systemic pro-inflammatory state, typical of the patient with cardiovascular risk factors, does also play a role in the determinism of endothelial damage and atheroma degeneration of the arteries. It is believed that this systemic inflammation, as documented by the determination of some humoral signs of inflammation (e.g. C-reactive protein, interleukin-6, tumor necrosis factor-α), may further contribute to an increase of cardiovascular risk. The inflammatory state can modulate the atherosclerotic process at various levels, determining endothelial activation, promoting leukocyte chemotaxis in the sub-intimal space of the arterial wall and therefore the formation of an atheromatous plaque rich in inflammatory cells; the latter represents the lesion responsible for the vast majority of the coronary and cerebrovascular events observed in subjects with cardiovascular risk factors.

NCT ID: NCT06243484 Recruiting - Clinical trials for Hypercholesterolemia

Effect of the Food Supplement TOTUM-070 on Lipid Metabolism

HEARTII
Start date: October 4, 2023
Phase: N/A
Study type: Interventional

This clinical trial is to confirm the effects of TOTUM-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood LDL cholesterol concentrations in moderately hypercholesterolemic subjects after 12 weeks of consumption (V3).

NCT ID: NCT06231459 Completed - Clinical trials for Hypercholesterolemia, Familial

Expression of Pro- and Anti-inflammatory Cytokines During Anti-PCSK9 in Familial Hypercholesterolemia

CytoEx-PCSK9
Start date: January 1, 2019
Phase: Phase 4
Study type: Interventional

Statins have been shown to reduce LDL cholesterol (LCLc) levels, stabilizing atheromatous plaque, reversing endothelial dysfunction and decreasing thrombogenesis. Novel pharmacological approaches, such as PCSK9 inhibitors (PCSK9i), effectively reduce LDL-c. In the clinical setting, there are cases of dyslipidemia showing lack of response to statin, known as statin-resistant familial hypercholesterolemia (SR-FH), where patients maintain a high cardiovascular risk despite statin therapy. Then, therapeutic alternatives are required. PCSK9i has shown to reduce cholesterol levels and risk of cardiovascular disease, particularly in patients with statin-resistant familial hypercholesterolemia; and recently, it has been hypothesized that PCSK9i have an effect on inflammation. Aim. To evaluate the effect of anti-PCSK9 treatment on markers related to the inflammatory response in patients with SR-FH. Methods. Non-randomized, non-controlled, before-after comparison, quasiexperimental, single-center study on patients older than 18 years, with diagnosis statin-resistant FH (SR-FH), who were attended at the Cardiology Department, Centro Médico Nacional "20 de Noviembre ISSSTE", Mexico City. SR-FH was defined as symptomatic cardiovascular disease accompanied by LDL-C concentration higher than 160 mg/dL despite maximally tolerated statin dose. Clinical-demographic and anthropometry data were collected during a direct interview. Blood sample was processed to obtain glycated hemoglobin complete blood count and serum lipids. Likewise, flow cytometry was used to characterize baseline circulating M1-, M2-macrophages and monocytes. Multiplexing of plasma samples was used to compare plasma fraktaline, IL-1, IL-4, IL-6, IL-8, IL-10, MCP-1 and TNF-alpha. Endpoints consisted of: 1) lower serum lipids; 2) modification of pro-inflammatory mediators (neutrophils, lymphocytes, NtLR, soluble pro-inflammatory cytokines). Quatitative data were resumed as mean ± SD; while categorical data as n(%).One-way T-test was applied. Statistical significance was considered if p <0.05.

NCT ID: NCT06230705 Not yet recruiting - Diabetes Mellitus Clinical Trials

Community Intervention to Improve CVD Risk Factor Control in Young American Indians

CIRCLE
Start date: September 2024
Phase: N/A
Study type: Interventional

American Indians are more likely to die from heart disease compared to other people in the United States. High levels of fat (lipids) and sugar (glucose) in the blood are related to heart disease. Young American Indians who are 15 to 39 years old have high lipid and glucose levels. This has led to heart disease later in life. This means they are likely to benefit from a program to lower these levels. In this project, researchers will work with American Indians in rural southwestern Oklahoma. The researchers will start by asking American Indians how they would like to design a program for younger members of their community. After getting permission, the researchers will take a small amount of blood from young community members. The researchers will measure lipid and glucose levels and ask those with high levels to be in the study. Then the researchers will do several measurements. These will include blood pressure, height, weight, diet, physical activity, tobacco and alcohol use, access to health care, and social support. The researchers will compare these measurements to similar measurements taken from young American Indians 20 years ago, collected through the Strong Heart Study, which is the longest running study measuring heart disease in American Indians. Next, the researchers want to know if the program they developed with the American Indian communities will work. To do this, they will put people in one of two groups. They will decide which group each person will be in using a process that is like flipping a coin (heads for one group, tails for the other group). One group will receive educational booklets about how to avoid getting heart disease. The other group will receive help from a community health worker. The community health worker will help participants to get to the doctor for treatment. They will also help participants change their diet and exercise routines and provide education about heart disease risk factors. After 9 and 18 months, the researchers will repeat the measurements to see if one of the groups has lower lipid or glucose levels. This program will support the National Heart, Lung, and Blood Institute's mission to "reduce human disease" by lowering lipid and glucose levels, which are related to getting heart disease. This will be done by using the community health worker model to help people go to the doctor and improve their lifestyle related to diet and exercise. The researchers will also be able to advance heart health in American Indians in rural Oklahoma by lowering factors related to heart disease.

NCT ID: NCT06227819 Completed - Heart Failure Clinical Trials

BVA-200 vs BVA-100 Validation Study

Start date: May 23, 2023
Phase:
Study type: Observational

The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device. Data from this study may be pooled with data from studies with similar design conducted at other sites, for the purposes of an FDA medical device submission.

NCT ID: NCT06220266 Recruiting - Clinical trials for Hypercholesterolemia

Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women

Start date: March 2, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to learn about the effects of phytoestrogen from Pueraria Mirifica in improvement of serum lipid parameters. The primary question it aims to answer are: • phytoestrogen from Pueraria Mirifica can reduce serum triglyceride, total cholesterol, LDL and increase HDL or not Participants will receive capsules which composed of dry weight 50 mg of Pueraria Mirifica twice a day for 2 months. Researchers will compare with starch capsules to see if there is the improvement of serum lipid parameters

NCT ID: NCT06192251 Recruiting - Obesity Clinical Trials

Complete Lifestyle Medicine Intervention Program

CLIP
Start date: November 6, 2023
Phase:
Study type: Observational

This project will use a mixed design and will be conducted at the West Parry Sound Health Centre. Based on similar studies there is an expected 10% drop-out rate so 20 participants per group will be invited to aim to have 15 finish. Total participants invited over the two-year study will be 40. The participants will be followed over a Complete 6-month Lifestyle medicine Intervention Program (CLIP) involving a collaboration between physicians, health coach, registered dietitians, and kinesiology. The CLIP will cover the 6 pillars of lifestyle medicine in 12-14 fundamentals of lifestyle medicine group classes.

NCT ID: NCT06184269 Completed - Clinical trials for Essential Hypertension

A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B"

Start date: December 23, 2023
Phase: Phase 1
Study type: Interventional

The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1017-1" and co-administration of "BR1017-1A" and "BR1017-1B" in healthy volunteers

NCT ID: NCT06165250 Recruiting - Clinical trials for Essential Hypertension

A Study to Evaluate the Efficacy and Safety of Co-administrated BR1018B and BR1018C

Start date: April 17, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this clinical trial is to evaluate the efficacy and safety of co-administrated BR1018B and BR1018C in patients with essential hypertension and primary hypercholesterolemia

NCT ID: NCT06164730 Not yet recruiting - Clinical trials for Heterozygous Familial Hypercholesterolemia

A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease

Start date: May 2024
Phase: Phase 1
Study type: Interventional

VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease (CAD) Who Require Additional Lowering of LDL-C. VERVE-102 Uses Base-editing Technology Designed to Disrupt the Expression of the PCSK9 Gene in the Liver and Lower Circulating PCSK9 and LDL-C. This Study is Designed to Determine the Safety and Pharmacodynamic Profile of VERVE-102 in This Patient Population.