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Dyslipidemias clinical trials

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NCT ID: NCT04977089 Recruiting - Clinical trials for Ischemic Heart Disease

Study of Lipid Profile of Patients With Chronic Coronary Syndromes at Sohag University Hospital

Start date: August 1, 2020
Phase:
Study type: Observational

Chronic coronary syndrome (CCS) is a newly described classification devised by the European Society of Cardiology (ESC) 2019 to replace the term "Stable Coronary Artery Disease (CAD). The main reason for effecting the change is the term is thought to better describe the disease process and encompass a wider spectrum of clinical, pharmacological, and pathophysiological entities. Using this new term, the disease atherosclerosis manifests as CAD is categorized into Acute Coronary Syndrome (ACS) and CCS. The main focus of introducing the concept of CCS is on the fact that CAD is a continuous phenomenon involving intravascular plaque aggregation and progression which has different evolutionary phases. Dyslipidemia is recognized as a prominent risk factor for cardiovascular (CV) disease. It is characterized by an elevation of serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), or triglycerides (TG) and reduced serum high-density lipoprotein cholesterol (HDL-C) concentration . Genetically determined and metabolically induced disturbances in lipid metabolism, as manifested in several types of dyslipidemia, have been shown to be causally related to the development of coronary artery disease (CAD). A diversity of clinical and angiographic studies has been made to evaluate the linkage between plasma lipid-control therapy in the development of recurrent cardiovascular events. Independent predictors of recurrent CVD events or death include age, smoking, hypertension (HTN), dyslipidemia, diabetes mellitus, chronic kidney disease, and the underutilization of medications recommended by current treatment guidelines.

NCT ID: NCT04943926 Recruiting - Hypertension Clinical Trials

Dietary Strategies for Remission of Type 2 Diabetes

CARBCOUNT
Start date: January 4, 2022
Phase: N/A
Study type: Interventional

In this project, the investigators will perform a multicenter randomised controlled trial to determine whether advice to consume a moderate, whole food-based low-carbohydrate high-fat (LCHF) ad libitum diet (CarbCount program) can produce and maintain equal remission rates of type 2 diabetes (T2D) as a nutritionally complete very-low-calorie formula diet followed by a energy-restrictive (i.e., calorie counting) diet (DiRECT principles). Within the principles of each approach, the dietary goals and change will be adjusted according to individual needs/capabilities conducive to long-term adherence. Furthermore, the investigators aim to determine whether the rate of diet-induced remission is reflected in/can be predicted by baseline or diet-induced changes in glucose variability (e.g., time-in-range measured by continuous glucose monitoring) and other factors such as anthropometric changes and genetic susceptibility. Each center will also conduct locally-lead standalone mechanistic research, including analyses of intra-abdominal/hepatic fat accumulation, adipose tissue biopsies and/or measurements of energy metabolism. Additionally, changes in medication use, nutritional status, cardiovascular disease risk, as well as adverse events, will be monitored.

NCT ID: NCT04909489 Recruiting - Dyslipidemias Clinical Trials

PDR and SKYD of Dyslipidemia's Characteristics From the Oxidative Stress Enhancement Caused by Inhibition of Serine Metabolic Pathway

PDR SKYD
Start date: April 21, 2021
Phase:
Study type: Observational [Patient Registry]

Clinical epidemiological investigation and modern statistics will be used. Syndrome was quantified by TCM syndrome score scale. Metabonomics, proteomics, transcriptomics, enzyme-linked immunosorbent assay, xanthine oxidation method and thiobarbital method will be used to detect the relevant indicators in serum, urine and tongue coating, and "disease syndrome cell model" will be constructed to detect the relevant indicators. Objective to clarify the epigenetic basis, molecular biological regulation mechanism and core function characteristics of phgdh expression decline caused by PDR and SKYD of dyslipidemia, analyze the correlation between phgdh, serine metabolic pathway product concentration and oxidative stress level, and reveal the scientific connotation of the disease syndrome.

NCT ID: NCT04882293 Recruiting - Clinical trials for Dyslipidemia Associated With Type II Diabetes Mellitus

Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.

Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

Phase IIIb, randomized, longitudinal, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia.

NCT ID: NCT04858308 Recruiting - Dyslipidemias Clinical Trials

Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.

Atorf-YOOrct
Start date: January 29, 2021
Phase: Phase 3
Study type: Interventional

Phase 3 study to evaluate the effiacay and safety of YYC506

NCT ID: NCT04761861 Recruiting - Schizophrenia Clinical Trials

Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia

Start date: February 16, 2021
Phase: Phase 2
Study type: Interventional

Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia.

NCT ID: NCT04701242 Recruiting - Clinical trials for Acute Myocardial Infarction

Ezetimibe Utilization Early After Acute Myocardial Infarction, "EzAMI Trial"

EzAMI
Start date: March 24, 2021
Phase: N/A
Study type: Interventional

Rationale: Patients with acute coronary syndromes are at an increased risk for recurrent adverse coronary events, particularly during the early period following their initial presentation. Early (in-hospital) initiation of high-intensity statins reduces the risk of recurrent events and is therefore recommended by the best current practice guidelines.(1,2) However, the delayed onset of action of statin therapy and given the frequent failure of patients to achieve the recommended LDL-C targets using statins alone (as per the current practice guidelines recommendations), might be placing large number of patients at increased risk during such a vulnerable period early after an ACS.(3) More rapid and effective reduction of LDL-C levels using combination therapy from the outset may therefore be beneficial in these patients. This hypothesis has been tested with combining Evolocumab and a statin in the recent EVOPACS study, in which this combination after ACS has shown to be safe and more effective in achieving LDL-C targets at 6 weeks compared to statin monotherapy.(4) However, Evolocumab (a PCSK9i) is an expensive drug which is not affordable by many healthcare systems in low- and middle-income countries. Ezetemibe, on the other hand, is a safe and a cheap drug that can prove to be extremely cost-effective if a meaningful and timely reduction in LDL-C levels can be achieved when combined with a statin early after an ACS. Study population Patients presenting with acute myocardial infarction, with baseline LDL-C levels not likely to achieve recommended targets on statin monotherapy. This is assumed to be with LDL-C level > 125 mg/dl for those not on lipid lowering therapy; or with LDL-C > 100 mg/dl on moderate intensity statin therapy at the time of presentation. Study design Prospective randomized controlled single-blinded trial. A sample size of 500 patients, 250 in each arm, was calculated to provide a power of 0.9 and an adjusted type 1 error as 0.05. Primary outcomes - Percentage of patients achieving target LDL-C levels (<70 mg/dl) at 6 weeks interval. (Efficacy endpoint) - Freedom from alanine transaminase elevation (ALT) more than 3 folds upper reference limit "URL" or statin associated muscle symptoms associated with CK elevation more than 4 folds URL. (Safety endpoint) Secondary outcomes - Percentage of patients achieving > 50% reduction of LDL-C and to levels below 70mg/dl at 6 weeks interval. - Percentage of LDL-C reduction at 6 weeks interval. - Reduction of high-sensitive C-reactive protein (hs-CRP) from baseline to 6 weeks interval. - Correlating statins efficacy to reduce LDL-C and likelihood to cause statins related adverse effects to genetic alleles of ABC [ATP Binding Cassette] types A1, G5 and G8, and of CYP450 isoenzymes. - MACE free survival at 1 year, (CV death; non fatal-MI; hospitalization for ACS, urgent unplanned revascularization and stroke).

NCT ID: NCT04700436 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia

REMBRANDT
Start date: January 3, 2020
Phase: Phase 4
Study type: Interventional

To compare and evaluate the effects of LDL-C and Triglyceride (TG) control on the first dose Ezetimibe/Statin (Rosuvastatin 5 mg/Ezetimibe 10 mg) combination therapy compared to the average dose Statin (Rosuvastatin 10 mg) monotherapy in patients with Type 2 diabetes with hypertriglyceridemia (TG > 200 mg/dL).

NCT ID: NCT04634591 Recruiting - Obesity Clinical Trials

The Bialystok Bariatric Surgery Study

BBSS
Start date: September 10, 2015
Phase:
Study type: Observational

The Bialystok Bariatric Surgery Study (BBSS) is a prospective observational cohort study of patients undergoing bariatric surgery at the First Clinical Department of General and Endocrine Surgery at the Medical University of Bialystok. The BBSS consists of a battery of baseline tests established one month prior to the surgery and repeated at one, three, six, twelve and twenty four-month follow-up clinical visits.

NCT ID: NCT04623567 Recruiting - Dyslipidemias Clinical Trials

Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances

Start date: December 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a randomized, positive drug parallel-controlled clinical trial in participants with glucose and lipid metabolism disturbances. A total of 96 participants will be recruited for the study, all of whom are diagnosed as type 2 diabetes mellitus combined with dyslipidemia. The subjects will be divided randomly into two groups and treated with either Jiangtang Tiaozhi Recipe or metformin. After 12 weeks of treatment, therapeutic effect of Jiangtang Tiaozhi Recipe will be evaluated based on the changes of HbA1c, fasting blood glucose, postprandial blood glucose, blood lipid, waist circumference, body mass index.