Clinical trial NCT02548832: Bezafibrate Plus Berberine in Mixed Dyslipidemia
Official title: Effect of Berberine Plus Bezafibrate Administration on the Lipid Profile of Patients With Mixed Dyslipidemia: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mixed Dyslipidemia
Keywords: Berberine
Bezafibrate
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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:

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.

Eligibility criteria: Inclusion Criteria:

A. Men and women

B. Accomplished age 30 to 60 years

C. Diagnosis of mixed dyslipidemia established to meet the following criteria:

* Total cholesterol \> 5,17 mmol/l.
* Triglycerides \> 1,7 mmol/l.

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 outcomes:
measure: Triglycerides After 90 Days
timeFrame: 90 days
measure: Total Cholesterol After 90 Days.
timeFrame: 90 days
measure: Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
timeFrame: 90 days
measure: High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
timeFrame: 90 days
measure: Very Low Density Lipoprotein After 90 Days
timeFrame: 90 days
Secondary outcomes:
measure: Body Weight (BW) After 90 Days
timeFrame: 90 days
measure: Body Mass Index (BMI) After 90 Days
timeFrame: 90 days
measure: Waist Circumference (WC) After 90 Days
timeFrame: 90 days
measure: Systolic Blood Pressure After 90 Days
timeFrame: 90 days
measure: Diastolic Blood Pressure After 90 Days
timeFrame: 90 days
measure: Fasting Serum Glucose (FSG) After 90 Days
timeFrame: 90 days
measure: Uric Acid After 90 Days
timeFrame: 90 days
measure: Creatinine After 90 Days
timeFrame: 90 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
state: Jalisco
Study officials:
affiliation: INTEC, CUCS, University of Guadalajara
name: Esperanza Martínez-Abundis
role: PRINCIPAL_INVESTIGATOR
References: