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.
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: 1. 12 patients will receive berberine, 1500 mg / day 2. 12 Patients will receive bezafibrate 400 mg / day 3. 12 patients will receive a combination of berberine (1500 mg / day) plus bezafibrate (400 mg / day). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Berberine 1500 mg, each 24 h for 90 days 1 Berberine capsule 500 mg for breakfast. 1 Berberine capsule 500 mg for lunch. 1 Berberine capsule 500 mg for dinner.
Bezafibrate capsule 400 mg each 24 h for 90 days. 1 Bezafibrate capsule 200 mg for breakfast. 1 Bezafibrate capsule 200 mg for dinner.
Berberine 1500 mg each 24 h for 90 days 1 Berberine capsule 500 mg for breakfast. 1 Berberine capsule 500 mg for lunch. 1 Berberine capsule 500 mg for dinner. Bezafibrate 400 mg each 24 h for 90 days. 1 Bezafibrate capsule 200 mg for breakfast. 1 Bezafibrate capsule 200 mg for dinner.
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, Mexico
Triglycerides After 90 Days
The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Time frame: 90 days
Total Cholesterol After 90 Days.
The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Time frame: 90 days
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Time frame: 90 days
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Time frame: 90 days
Very Low Density Lipoprotein After 90 Days
The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5.
Time frame: 90 days
Body Weight (BW) After 90 Days
The body weight was evaluated at baseline and after 90 days after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.
Time frame: 90 days
Body Mass Index (BMI) After 90 Days
The BMI was calculated at baseline and after 90 days by the square of the body height, and is universally expressed in units of kg/m\^2, resulting from mass in kilograms and height in metres.
Time frame: 90 days
Waist Circumference (WC) After 90 Days
The waist circumference was evaluated at baseline and after 90 days after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.
Time frame: 90 days
Systolic Blood Pressure After 90 Days
The systolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.
Time frame: 90 days
Diastolic Blood Pressure After 90 Days
The diastolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.
Time frame: 90 days
Fasting Serum Glucose (FSG) After 90 Days
The glucose oxidase technique (Beckman Instruments, Inc., Brea, California, USA) was used to determine fasting serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of \<1.
Time frame: 90 days
Uric Acid After 90 Days
The blood sample for the determination of uric acid was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Time frame: 90 days
Creatinine After 90 Days
The blood sample for the determination of creatinine was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.