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Hyperlipidemias clinical trials

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NCT ID: NCT01678183 Completed - Hypertension Clinical Trials

Financial Incentives for Medication Adherence

FIMA
Start date: September 2012
Phase: N/A
Study type: Interventional

This study is a pilot study. The investigators have designed a randomized, controlled trial of financial incentives in medication adherence, focusing primarily on poorly-controlled diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that many patients do not take their medications as prescribed by their doctors. This contributes to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and death. The investigators hypothesize that use of a financial incentive will motivate patients to improve their medication adherence and ultimately their control of their chronic diseases. The investigators plan to identify patients who get Primary Care at Boston Medical Center who still have high blood sugars more than a year after their diabetes diagnosis, and randomize them to a control arm, or one of two intervention arms. Subjects will be approached at the time of a regularly-scheduled appointment with their Primary Care doctor and offered the opportunity to participate in the study. All subjects who agree to participate in the study will meet with a Clinical Pharmacologist to review their medications in detail, and then undergo randomization. Subjects in the first intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month. Subjects in the second intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month, and a one-time payment at the conclusion of the study based on the amount of hemoglobin A1c decrease. The investigators will enroll a total of 100 subjects in the study, and anticipate an observational cohort of approximately 1,000 patients. All patients who are eligible for the study but who are not enrolled in the study and have not declined to participate in the study will become the observational cohort for the study. The observational cohort will be used to determine whether randomization to the control arm of the study has a negative, rather than neutral, effect on patients. At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to have their blood pressure checked and to have their blood drawn so that their blood sugar and cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid panel, systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and macrovascular complications, and death.

NCT ID: NCT01675154 Terminated - Clinical trials for Type 1 Hyperlipoproteinemia

Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia

Start date: November 2015
Phase: Phase 2
Study type: Interventional

Funding Source - FDA OOPD This study is being done to find out whether an investigational (not approved by FDA ) drug called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in combination can treat the high blood fat (elevated triglycerides)levels found in the condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone, the current standard medical care. It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The researchers are interested in learning whether any one of these drugs when given alone or in combination is more effective and safe in treating T1HLP.

NCT ID: NCT01671254 Completed - Hyperlipidemia Clinical Trials

Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation

Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of this 8-week intervention trial is to investigate the effect of a dietary supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in healthy hyperlipidemic subjects

NCT ID: NCT01649986 Not yet recruiting - Hyperlipidemia Clinical Trials

Nutraceuticals to Improve Lipid Profile in European Countries

PIN
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk' according to current scientific guidelines. In the real world, however, statin treatment is often discontinued due to side effects. In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom only non-pharmacologic intervention and prevention strategies are currently prescribed. Along with non-pharmacologic intervention and prevention strategies, newer approaches to reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived from foods with cholesterol lowering actions. The primary objective of this study is twofold: First, to prospectively compare in the real world clinical practice the efficacy and tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic intervention with a nutraceutical-based protocol in patients in whom statin treatment is not tolerated or is not indicated. Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a nutraceutical-based protocol among European countries.

NCT ID: NCT01647438 Completed - Obesity Clinical Trials

Translating a Heart Disease Lifestyle Intervention Into the Community

Start date: August 2012
Phase: N/A
Study type: Interventional

Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle intervention to improve the cardiovascular health of underserved South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) Americans. Participants in this study will be randomly assigned to either a group to receive heart disease prevention classes or to another group where they will receive written materials about heart disease prevention.

NCT ID: NCT01645046 Completed - Clinical trials for Hyperlipoproteinemia

The Effects of Coenzyme A on Serum Lipids in Patients With Hyperlipidemia

Start date: October 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A (CoA) capsule in Chinese patients with moderate dyslipidemia.

NCT ID: NCT01644942 Completed - Obesity Clinical Trials

Identification in Obese Patients of the Mechanism Involved in Intramuscular Lipid Accumulation

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

The study aims to determine in obese patients the implication of intramuscular lipid accumulation in relation with insulin resistance and defect in lipid oxidation.

NCT ID: NCT01642355 Completed - Obesity Clinical Trials

Prevention Trial to Achieve Cardiovascular Targets

IMPACT
Start date: June 2012
Phase: N/A
Study type: Interventional

The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets) is to determine the best management strategy for patients undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will enroll 400 patients post-cardiovascular intervention. The study will compare different cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult, and (3) cardiovascular prevention consult with a behavioral intervention program over a 6-month period. The trial hypothesis is that for patients undergoing a cardiovascular intervention, a prevention consult and behavioral intervention is superior to usual care in reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary endpoints include other lipid values, metabolic risk, smoking cessation, physical activity, nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin enrollment in the June of 2012.

NCT ID: NCT01634906 Completed - Atherosclerosis Clinical Trials

Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy

EBABAST
Start date: July 2012
Phase: N/A
Study type: Interventional

Background: preliminary data have shown that erythrocyte-bound apolipoprotein B (ery-apoB) may be protective against atherosclerosis. However, statins may have an effect on ery-apoB. Objective: to investigate the effect of statins on ery-apoB levels. Study design: a non-randomized intervention study. Ery-apoB will be measured twice in volunteers who are on statin therapy for medical reasons. After a baseline measurement of ery-apoB volunteers will discontinue their statin use for a period of six weeks followed by a second measurement of ery-apoB. Consecutively subjects will start with their original statin therapy again. Study population: patients on statin therapy aged 18 years or older. Intervention: temporary discontinuation of statin therapy for a period of six weeks. Main study endpoints: changes in ery-apoB levels. Risks, burden and benefits on participation: volunteers will visit the outpatient clinic twice, the second visit will be exactly six weeks after the first visit. The volunteers' general practitioner and medical specialist (internist or cardiologist) will be informed about their participation. Subjects have to fast for 10 hours before every visit and venous blood samples will be drawn on both visits (a total of 36ml of blood). Subjects will discontinue their usual statin therapy for a period of six weeks. No major risks are involved with temporary discontinuation of statin therapy in stable chronic cardiovascular disease. Volunteers will receive 25 euro's in total for participation. Participation serves to further investigate the relation of statins and potentially beneficial binding of apoB on erythrocytes.

NCT ID: NCT01618071 Completed - Vasodilation Clinical Trials

Vascular Effects of Triglyceride-rich Lipoproteins

Start date: June 2012
Phase: N/A
Study type: Interventional

Many types of cardiovascular disease begin when the layer of cells lining blood vessels (endothelial cells) start to function abnormally. This causes white blood cells (monocytes) to enter the blood vessel wall and eventually form lesions. Fats from foods we consume are carried in the blood for 3-8 hours after a fatty meal in small particles known as chylomicrons (CM) and chylomicron remnants (CMR). The overall aim of this project is to investigate the idea that n-3 polyunsaturated fatty acids (PUFA) protect against heart disease by modifying the effect of CMR on endothelial cells and monocytes. We hypothesize that n3-PUFA carried in CMR reduce detrimental events which promote blood vessel damage and activate protective mechanisms to improve the function of arteries.