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Dyslipidemias clinical trials

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NCT ID: NCT06463561 Not yet recruiting - Dyslipidemias Clinical Trials

CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea

CPAPLIP
Start date: June 20, 2024
Phase: Phase 4
Study type: Interventional

Clinical Trial Phase IV Indication: Moderate-severe obstructive sleep apnea and dyslipidemia. Objectives: Main objective: To test whether 12 months of CPAP treatment associated with conventional pharmacological treatment improves the lipid profile of patients with dyslipidemia and moderate to severe OSA. Secondary objectives: - To test whether 12 months of treatment with CPAP associated with conventional pharmacological treatment improves serum uric acid concentration in patients with dyslipidemia and moderate-severe OSA. - To determine the additional medium- and long-term effect of CPAP on insulin resistance in patients with dyslipidemia and moderate-severe OSA. - To evaluate the impact of CPAP treatment on cardiovascular risk reduction in patients with dyslipidemia and moderate-severe OSA. - To analyze the impact of supplemental CPAP treatment on glycemic control and C-reactive protein concentration in patients with dyslipidemia and moderate-severe OSA. - To establish the impact of supplemental CPAP therapy on health-related quality of life in patients with dyslipidemia and moderate-severe OSA. - To evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and intake-regulating hormones in patients with dyslipidemia and moderate-severe OSA. - To relate CPAP-induced changes in serum lipid and uric acid concentration to changes in basal inflammatory response, oxidative stress, sympathetic activity, and intake-regulating hormones. - To identify the subgroup of patients with dyslipidemia and moderate-severe OSA in whom 12 months of CPAP treatment achieves a more marked reduction in serum lipids and uric acid. Design Randomized, parallel-group, nonblinded, controlled clinical trial with conventional treatment. Study population Subjects aged 35 to 80 years with a diagnosis of dyslipidemia made at least six months ago and with moderate-severe obstructive sleep apnea (OSA) not requiring CPAP treatment according to conventional indications. Sample size: 110 patients in each treatment arm. Treatment Patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms: 1. Conventional hygienic-dietary recommendations and promotion of daily physical activity. 2. Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP). Efficiency variables - Main variables: LDL-cholesterol and uric acid. - Total cholesterol, HDL-cholesterol and triglycerides. - Basal blood glucose, glycosylated hemoglobin (HbA1c), creatinine and C-reactive protein. - Systemic biomarkers: inflammatory (IL-6, IL-8 and TNF-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, VCAM-1 and ICAM-1), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A/hypocretin 1 and ghrelin). - Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ. Safety variables - Clinical adverse event reporting. - CPAP compliance (average hours of use per day). - Epworth Sleepiness Questionnaire. - Development of cardiovascular events.

NCT ID: NCT06443814 Completed - Metabolic Syndrome Clinical Trials

Trial of Meditation for Cardiometabolic Disease in Older Black Women

Start date: July 2001
Phase: Phase 2
Study type: Interventional

This randomized controlled trial compared the efficacy of stress reduction with meditation to a health education (HE) group in 201 older African American women over a one-year study period. They were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM( program or 2) a health education (HE) program. Women participants were recruited, tested, and instructed at two clinical sites: Washington, DC and Atlanta, GA. Outcome measures were carotid intima medial thickness, lipid profile, glucose and insulin resistance, and behavioral factors.

NCT ID: NCT06426017 Recruiting - Obesity Clinical Trials

Impact of FTO Gene Variation on Body Composition, Lipid Profile, Insulin Resistance, Advanced Glycation End-Products and Ghrelin Levels in Response to Hypocaloric, Protein Rich-Diet

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Obesity is a widespread disease that basically develops from unhealthy lifestyle and genetics. The Fat-mass and obesity associated (FTO) gene affects appetite and energy intake of the body, thus elevating fat mass and body weight. The single nucleotide polymorphism (SNP) rs9939609 of the FTO gene is a common variant in different ethnic groups, and its A allele is associated with increased body mass and waist circumference. Hence, the carriers of rs9939609 SNP are prone to weight gain if a healthy diet and lifestyle are not maintained. Similarly, high levels of serum cholesterol and triglycerides, while low levels of high-density lipoproteins are observed in carriers of rs9939609 AA genotype. For individuals having FTO rs9939609 A allele, consumption of hypocaloric diets (1500 kcal/day) consisting of high protein foods up to 25-30% of total daily energy intake might help reduce body weight. However, weight loss tends to vary in individuals after consuming the same diet under similar environmental conditions, so it is important to know the effect of different genotypes that might cause this variation. The study aimed to genotype overweight and obese adults for FTO rs9939609 polymorphism and to determine the effect of this polymorphism on body weight, BMI, waist and hip circumferences, lipid profile, insulin sensitivity, ghrelin levels, inflammatory markers and advanced glycation end-products in these individuals after consumption of a hypocaloric, high-protein diet for 4 weeks.

NCT ID: NCT06409962 Recruiting - Dyslipidemias Clinical Trials

A New Technological Intervention to Address Childhood Obesity:

NURSPEDIAOBE
Start date: May 30, 2024
Phase: N/A
Study type: Interventional

Childhood obesity is a global public health issue, with rising prevalence rates. In Spain, the problem is significant, particularly in the southern regions. Factors contributing to childhood obesity include dietary habits, lack of physical activity, and socioeconomic influences. Efforts to address childhood obesity in Spain include various programs focusing on dietary modification, increased physical activity, and family involvement. Despite these initiatives, there is a need for continued intervention, as changing dietary and lifestyle patterns have led to reduced fruit and vegetable consumption and increased sedentary behavior among children. Childhood obesity has concerning health implications, including heart-related issues. Echocardiography plays a vital role in early detection. Given the limited research on the impact of childhood obesity on musculoskeletal development and mobility, a comprehensive study is needed to analyze its prevalence and associated factors. The study aims to assess the effectiveness of nutritional interventions administered by school nurses. In summary, childhood obesity in Spain is a growing concern, with multifaceted causes and health implications. Ongoing efforts are required to combat this issue and promote healthier lifestyles among children.

NCT ID: NCT06405880 Not yet recruiting - Diabetes Clinical Trials

Pharmacist Case Finding and Intervention for Vascular Prevention Trial

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

Heart disease is a common and serious medical condition which causes nearly one in every three deaths worldwide every year. The factors which increase people's risk for heart disease are well-known, but there needs to be more support given to people to reduce their risk of heart disease. Pharmacists are front line primary healthcare providers who see patients more frequently than any other healthcare provider and can help people reduce their risk of heart disease. This research project aims to see whether a pharmacist-led intervention can help people reduce their risk of heart disease. The potential impact of this project is to empower people to understand how to reduce their risk of heart disease and reduce the burden of heart disease on the community.

NCT ID: NCT06401122 Not yet recruiting - Dyslipidemias Clinical Trials

Comparison of Dyslipidemia Among Diabetics Versus Non Diabetics in Haemodialysis Patients

Start date: June 1, 2024
Phase:
Study type: Observational

- How dyslipidemia common among Diabetic and non- Diabetic Haemodialysis patients. - How differ dyslipidemia types among Diabetic and non- Diabetic in Haemodialysis patients. (Qualitative difference).

NCT ID: NCT06388668 Not yet recruiting - Clinical trials for Myocardial Infarction

Lipid Testing After Myocardial Infarction at the Montreal Heart Institute

Start date: June 2024
Phase:
Study type: Observational

Because treatment decisions are usually based on a single measurement of the lipid panel at the time of an admission for an MI, the overarching objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization. It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute. Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission. Thereafter, the levels of the different lipid values from the panel will be compared between day 0, day 2, and 4-6 weeks after discharge.

NCT ID: NCT06386419 Not yet recruiting - Clinical trials for Primary Hypercholesterolemia

A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Start date: May 15, 2024
Phase: Phase 4
Study type: Interventional

This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium.

NCT ID: NCT06382298 Not yet recruiting - Clinical trials for Overweight and Obesity

Cottonseed Oil Versus Matched PUFA Effects

Start date: August 2024
Phase: N/A
Study type: Interventional

Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk. The specific aims are: - Examine the impact of CSO vs. PUFA on fasting and postprandial lipids. - Examine the impact of CSO on other markers of chronic disease risk. Participants will be asked to: - Consume provided meal replacement shakes daily for 28-days. - Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials, - Attend two longer (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. Researchers will compare CSO vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets.

NCT ID: NCT06381947 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients

BESAFE
Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

Statin intolerance occurs in up to 15-20% of treated patients. The combined use of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors with ezetimibe is commonly performed in these patients, and has been associated with an estimated LDL-C reduction of 65-70%. This drug combination may be insufficient to reach the LDL-C target in high- and very-high-risk patients with statin intolerance, also considering the goals recommended by the current international guidelines. Also, PCSK9 inhibitor dosage escalations frequently fail to achieve the target. Doubling the dosage of alirocumab from 75 mg to 150 mg, when administrated as monotherapy, determines a further reduction of only 3,6% of LDL-C serum level. The full dose of Evolocumab (420 mg every two weeks), was approved only in the setting of homozygous familiar hypercholesterolemia. Bempedoic acid is an oral, once-daily prodrug, metabolized in the liver to an active inhibitor of ATP-citrate lyase, blocking cholesterol synthesis upstream of 3-hydroxy-3-methylglutaryl-coenzyme A reductase and thereby increasing hepatic expression of the LDL receptor and decreasing circulating LDL-C levels. The CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Harmony trial demonstrated that bempedoic acid in addition to maximally tolerated statin therapy did not lead to a higher incidence of adverse events compared to placebo and significantly lowered LDL-C levels. In the CLEAR Serenity study, bempedoic acid showed a safe and effective profile compared with placebo in patients with statin intolerance. In the CLEAR Tranquility, it provided an oral therapeutic option complementary to ezetimibe in patients intolerant to high-dose statins who required additional LDL-C lowering. The synergistic effect of bempedoic acid plus PCSK9 inhibitors has been investigated by one phase 2 trial (NCT03193047), which showed a statistical superiority of bempedoic acid plus evolocumab strategy versus placebo plus evolocumab in terms of percent change in LDL-C up to 2 months. To date, no randomized phase 3 clinical trial have evaluated the effect of bempedoic acid in association with anti-PCSK9 and ezetimibe in statin-intolerant patients not attaining the recommended LDL-C target. The investigators hypothesized that the association of bempedoic acid with PCSK9 inhibitors and ezetimibe may be safe and effective in reducing LDL-C in statin-intolerant patients.