Dyslipidemia in Type 2 Diabetes (0767-034)
Diabetes MellitusType II1 moreThe purpose of the study is to compare the lipid-altering effects of MK0767, glipizide, and pioglitazone after 12 weeks of treatment. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).
Peru Longitudinal Study
Cardiovascular DiseasesDiabetes Mellitus3 moreThe purpose of this study is to evaluate the change in disease prevalence over time in impoverished urban communities in Lima, Peru.
Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study
Type 2 DiabetesDyslipidemiaDouble-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo, fenofibrate, metformin, or metformin and fenofibrate combination.
Effect of Aerobic Training on the Health Parameters of Postmenopausal Women With Multimorbidity...
MultimorbidityMultiple Chronic Conditions2 morePeople affected by multiple chronic diseases have a greater chance of hospitalization, longer hospital stays, worse general health, worse physical and mental function and lower functional capacity, with an average risk of 50% of functional decline with each additional condition. The frequency of multimorbidity is higher in older, inactive women, who live in urban areas in low- and middle-income countries, the most affected by multimorbidity. The practice of physical exercise is an important component in the prevention of multiple chronic diseases, in which lower levels of physical activity were associated with an increased prevalence of multimorbidity in women aged 16 to 24 years. And regardless of the presence of multimorbidity, engaging in a healthier lifestyle, including regular physical activity, was associated with up to 7.6 more years of life for women, improving the individual's general health status even when multimorbid. The hypothesis is that multimorbid women have a worse general health status when compared to women without multimorbidity, but aerobic exercise will be able to improve health parameters in 12 weeks of training. This is a quasi-experimental clinical trial with a 12-week aerobic training intervention in postmenopausal women with and without cardiometabolic multimorbidity. Participants were allocated into groups according to the amount of cardiometabolic diseases, with the Morbidity group (MORB) being composed of women with one or no chronic cardiometabolic disease and the Multimorbidity group (MULTI) with two or more chronic cardiometabolic diseases. The assessments of arterial stiffness, 24-hour ambulatory pressure, blood pressure variability, heart rate variability, lipid and glucose profile, body composition and climacteric symptoms were performed before and after the training period. The study was carried out at the Laboratory of Cardiorespiratory and Metabolic Physiology at the Faculty of Physical Education of the Federal University of Uberlândia, Uberlândia, Brazil and approved by the Ethics Committee for studies in humans (CAEE: 12453719.1.0000.5152). All participants signed a consent form. The experiments followed the principles of the Declaration of Helsinki. The program consists of aerobic physical exercises performed three times a week on non-consecutive days for 12 weeks with an intensity of 65% to 75% of the reserve heart rate.
Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR)
Osteoarthritis Knees BothMyocardial Infarction5 moreThis study aims to develop, implement, and determines the effectiveness of a personalized medicine approach to each individual's phenotype, based on an innovative physical exercise program to promote the treatment of pain and functional limitation resulting from knee osteoarthritis (KOA) in patients recovering after acute myocardial infarction (AMI) and cardiovascular risk (CVR). This randomized clinical study is important due to the lack of evidence according to the effectiveness of a personalized physical exercise intervention in people after MI or CVR with simultaneous KOA. Some studies have shown the existence of a relationship between OA and cardiovascular diseases (CVD), including coronary artery disease, stroke, congestive heart failure, peripheral arterial disease, cardiac procedures, or death related to CVD, since individuals with OA have a higher prevalence of CVD than individuals without OA. Sedentary behaviour is a risk factor for AMI, CVR and KOA, and, at the same time, physical exercise is a common non-pharmacological treatment for people suffering from these conditions, namely in the control of joint pain, gains in functional capacity, and the improvement of cardiorespiratory functional capacity, whose impact can be felt in level of quality of life. Chronic diseases have a significant impact on the global burden of disease, particularly CVD and OA, with the added presence of obesity also contributing to a high rate of all-cause morbidity and mortality, representing a substantial health burden and with growing implications for individuals, health systems and socioeconomic costs. The presence of OA seems to lead to an increased risk of developing CVD. Several mechanisms have been proposed to explain this relationship. Chronic inflammation associated with OA is one of the hypotheses suggested to explain the increased risk of CVD in these individuals. Furthermore, the pain and disability associated with OA may also limit participation in exercise/physical activity, influencing other risk factors associated with both chronic diseases, such as weight gain. The lack of studies about physical exercise intervention on people that suffered acute myocardial infarction or is in cardiovascular risk with simultaneous knee osteoarthritis and the lack of offer of phase III cardiac rehabilitation in Algarve motivated the development of this study, with the assumption of adopting a healthier lifestyle.
Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A
HypercholesterolemiaDyslipidemiaA Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or Mixed Dyslipidemia
Study of Adherence to Antihypertensive Drugs and Statins by Hair Analysis
Arterial HypertensionDyslipidemias3 moreThe problem of adherence to long-term therapies has been known for years and occurs substantially in all countries, although with greater severity in developing countries. The investigators designed a prospective open study in which 200 patients followed for hypertension at the centers of the Italian Society of Hypertension (SIIA) adhering to the project will be evaluated on the basis of their clinical characteristics, the presence of comorbidities and the therapeutic scheme in place and will be subjected to hair sampling for the analysis of drugs of interest and their possible metabolites in this matrix. The use of the prescribed drugs is recorded along with the relevant clinical parameters and preliminarily evaluated by application of a questionnaire. At the first visit, patients who have been prescribed continuously in the 3 months preceding the study the same active ingredients will be invited to participate in the study, which involves a hair sampling. They will then be prescribed the same active ingredients according to the same scheme if the blood pressure values are within the recommended limits. When more than one antihypertensive drug is present in the therapeutic scheme, they will be prescribed in a single pill, as recommended. For patients with uncontrolled blood pressure, the therapeutic scheme will be modified with the inclusion of other active ingredients and using drug combinations when possible. Patients treated with statins will continue the treatment according to clinical indication using associations with antihypertensive drugs. Patients will be examined and re-tested 3-4 months after the first visit. The use of prescribed medications will be recorded along with clinical parameters of interest and preliminarily evaluated by application of questionnaires. At each of the two visits, the investigating physician will measure blood pressure using a semi-automatic device The 24-hour blood pressure monitoring will be used. Hair extraction ad UHPLC-QQQ/MS analysis will be performed. Concentrations of active ingredient and any metabolites in the keratin matrix are expressed in ng or fractions of ng/mg.
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy...
DyslipidemiaPrimary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy. Secondary Objectives: To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density lipoprotein [IDL] particle number). To assess changes in glycemic parameters with alirocumab vs. usual care treatment. To demonstrate the safety and tolerability of alirocumab. To evaluate treatment acceptance of alirocumab. To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development. To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).
Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male...
DyslipidemiaStudy to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.
Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
DyslipidemiaType II DiabetesRandomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.