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About
Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has increased over the last decade. Part of the components of metabolic syndrome and consensus so far contemplated to increased triglycerides (TG) and reduced high-density lipoprotein cholesterol (HDL-C) as part of the elements for classification, which includes mixed dyslipidemia.
Currently, fibrates, such as bezafibrate, are drugs used in treating hypertriglyceridemia, besides reducing the risk of coronary disease. However, although this treatment is safe, it is not without risks; with increased prevalence of adverse effects as the dose thereof is increased or joins combination with a statin drug for the treatment of mixed dyslipidemia long term.
Among the alternative therapies is berberine, which to reduce cholesterol and triglycerides may be useful in combination with bezafibrate in the treatment of mixed dyslipidemia and as an option with lower cost and lower frequency of adverse events.
Full description
The aim of this study is to evaluate the effect of berberine plus bezafibrate administration on the lipid profile of patients with mixed dyslipidemia.The investigators will conduct a double-blind randomized pilot clinical trial with parallel groups in men and women aged 30-60 years old with diagnosis of mixed dyslipidemia.
Patients will be assigned to 3 groups:
All participants will be determined before and after the intervention: lipid profile, total cholesterol (TC), triglycerides (TG), HDL-C, low-density lipoprotein cholesterol (LDL-C), very low-density lipoprotein (VLDL).
Also weight, Body Mass Index (BMI), waist circumference (WC), glucose, systolic blood pressure (SBP), diastolic blood pressure (DBP), creatinine (CR) uric acid (UA) and tolerability.
Statistical analysis was performed upon the sample of subjects.
Previous start the statistical analysis of the groups will proceed to verify the behavior of the distribution of the variables included by Z Kolmogorov-Smirnov goodness of fit.
The distribution of all the variables under this test is cataloged in normal or not normal, which define the type of statistical test would be performed (parametric or non-parametric). However, based on the sample size, non-parametric tests will be those considered most suitable for application.
The data obtained will be expressed and presented using measures of central tendency and dispersion for quantitative (mean and standard deviation) variables and qualitative variables are expressed as frequencies and percentages.
Enrollment
Sex
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Inclusion criteria
A. Men and women
B. Accomplished age 30 to 60 years
C. Diagnosis of mixed dyslipidemia established to meet the following criteria:
D. BMI of 25 kg / m^2 to 39.9 kg / m^2, weight stable over the past three months, defined as a variability in the lower body weight of 5%.
E. No drug treatment for lipid profile 3 months prior to baseline.
F. Women must ensure a non-hormonal method to avoid pregnancy during the study period.
G. Written information consent
Exclusion criteria
A. Removal for informed consent letter
B. Loss of monitoring
C. Presence of serious adverse event
D. Adherence to treatment <80%
E. Consumption of drugs known about lipid profile, glucose metabolism, blood pressure and body weight during the intervention period influence
F. Intolerance or not tolerability or hypersensitivity to the compounds used in the study
Primary purpose
Allocation
Interventional model
Masking
36 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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