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Dyslipidemias clinical trials

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NCT ID: NCT00422266 Completed - Dyslipidemia Clinical Trials

Effect of Omega -3 Fatty Acids Supplements and Plant Sterol Enriched Food in Dyslipidemic Adults

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The incidence of chronic degenerative diseases, especially cardiovascular disease (CVD), is high world over and especially in India. High blood cholesterol and triglyceride levels are known to be important risk factors for CVD. There is a strong body of evidence for the beneficial effects of plant sterols on blood total and LDL-cholesterol and omega-3 fatty acids from fish on blood triglycerides. However, the combined benefits of consuming both plant sterols and omega-3 fatty acids from fish oil on blood cholesterol and triglycerides has not been investigated previously, except in one study where the methodology used was not the most appropriate for testing such a combination. In addition, most studies on plant sterol efficacy realised so far were done in Western countries. The present study will investigate the efficacy of plant sterols and omega-3 fatty acids from fish oil on improving the cardiovascular risk profile of Indian adults with dyslipidemia. It is expected that, after 4 weeks of intervention, men consuming both plant sterols and omega-3 fatty acids from fish oil will have a lower cardiovascular risk profile than men receiving only plant sterols or only fish oil or none of these dietary supplements.

NCT ID: NCT00422006 Completed - Obesity Clinical Trials

Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance

Start date: February 2008
Phase: N/A
Study type: Interventional

Experimental results are strongly suggesting that PCSK9 and FXR could occur in the physiopathology of human joined dyslipidemia. But no data in the literature can validate the potential role of these two genes in the lipidic and glucidic metabolism control in physiopathological situations. This protocol is based on the hypothesis that the expression levels of PCSK 9 and FXR are modified for some patients suffering from insulin resistance and dyslipidemia.

NCT ID: NCT00419484 Completed - Hypertension Clinical Trials

Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes

Start date: March 2004
Phase: Phase 4
Study type: Observational

We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.

NCT ID: NCT00412698 Terminated - Obesity Clinical Trials

European Trial About Effect of RimoNabant on Abdominal Obese Patients With dysLipidemia

ETERNAL
Start date: December 2006
Phase: Phase 3
Study type: Interventional

Primary : To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C), triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities. Main Secondary : To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients. In selected sites, a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters.

NCT ID: NCT00412113 Completed - Hypertension Clinical Trials

A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

TOGETHER
Start date: January 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

NCT ID: NCT00409240 Completed - Hypertension Clinical Trials

Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Start date: October 2006
Phase: Phase 3
Study type: Interventional

Our study intends to test the efficacy of pharmacist-led group interventions on a weekly basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure.

NCT ID: NCT00408057 Completed - Clinical trials for Cardiovascular Diseases

Guidelines Based Undertaking for Improvement in Dyslipidemia Related Events (GUIDE )

GUIDE
Start date: December 2005
Phase: Phase 4
Study type: Observational

This is a multi-center, open label observational study conducted over 26 weeks. Approximately 2,500 high-risk patients with an elevated LDL-C level (> 2.5 mmol/L) will be enrolled. Patients meeting all inclusion criteria and having none of the exclusion criteria at Visit 1 (Screening) will be included in the study. Eligible patients that agree to participate and sign an informed consent will be treated with either statin therapy (increased or started or switched) or combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient. After enrollment there are a total of three scheduled clinic visits. All patients will have vital signs measured as well as a brief physical examination performed at Visit 1 (Screening). At Visit 2 (6 weeks) patients with LDL-C > 2.5mmol/L will be treated with either statin therapy increase or combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient. At Visit 3 (12 -18 weeks) patients with LDL > 2.5 mmol/L will be treated with combination of statin and ezetimibe 10 mg as per Study Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient. At final Visit 4 (24-26 weeks) safety and efficacy of treatment will be reviewed. Following Visit 4 physicians will continue to treat these patients according to their clinical judgment.

NCT ID: NCT00405197 Completed - Hypertension Clinical Trials

MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

Start date: November 2006
Phase: N/A
Study type: Interventional

Background: During the 1990s, the prevalence of the metabolic syndrome in the Netherlands ranged from 3% in women of 20-39 yrs to at least 33% in men 55 yrs and older and it is expected to increasing. Prevention is therefore warranted. In this respect the amount and type of fat in the diet deserves attention. Recently, an intervention study reported that a diet high in mono-unsaturated fatty acids (MUFA) such as from olive oil, increased insulin sensitivity in healthy subjects. However, additional beneficial effects can be expected from the Mediterranean diet as a whole. Hypothesis: Replacing saturated fatty acids (SFA) by mono-unsaturated fatty acids (MUFA) will improve hyperinsulinemia and dyslipidemia, and a typical Mediterranean diet will even have more pronounced effects. Study objectives: To investigate the impact of the Mediterranean diet, and especially the intake of MUFA, on markers of the metabolic syndrome in high-risk subjects. Methods: The controlled dietary intervention will include 60 subjects aged 40-65 years with moderate abdominal obesity. After a run-in diet for 2 weeks they will be assigned randomly to receive one of the three diets for a period of 8 weeks. Measurements of serum insulin concentration and other parameters will be carried out at weeks 2 and 10. Expected results: Our study will provide information on the role of MUFA and the expected beneficial impact of other factors of the Mediterranean type of diet on the metabolic syndrome.

NCT ID: NCT00405171 Completed - HIV Infections Clinical Trials

Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia

Start date: June 2003
Phase: Phase 4
Study type: Interventional

Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.

NCT ID: NCT00400231 Completed - Clinical trials for Metabolic Syndrome x

The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

Start date: August 2005
Phase: Phase 2
Study type: Interventional

Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate; or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C, insulin resistance, and markers of inflammation.