Bezafibrate Plus Berberine in Mixed Dyslipidemia

NCT ID: NCT02548832

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2020-04-01

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.

Conditions

Mixed Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Berberine

Berberine 500 mg with breakfast, meal, and dinner.

Group Type: EXPERIMENTAL

Berberine

Intervention Type: DRUG

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

Bezafibrate 200 mg on breakfast and dinner.

Group Type: EXPERIMENTAL

Bezafibrate

Intervention Type: DRUG

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 plus Bezafibrate

Berberine 500 mg with breakfast, meal, and dinner, and bezafibrate 200 mg only on breakfast and dinner.

Group Type: EXPERIMENTAL

Berberine plus Bezafibrate

Intervention Type: DRUG

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.

Interventions

Berberine

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.

Intervention Type: DRUG

Bezafibrate

Bezafibrate capsule 400 mg each 24 h for 90 days.

1 Bezafibrate capsule 200 mg for breakfast.

1 Bezafibrate capsule 200 mg for dinner.

Intervention Type: DRUG

Berberine plus Bezafibrate

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.

Intervention Type: DRUG

Other Intervention Names

Berberine, bezafibrate

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Esperanza Martínez-Abundis

Dr. Esperanza Martínez-Abundis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esperanza Martínez-Abundis

Role: PRINCIPAL_INVESTIGATOR

INTEC, CUCS, University of Guadalajara

Locations

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

EABYBL

Identifier Type: -

Identifier Source: org_study_id