Bezafibrate Plus Berberine in Mixed Dyslipidemia

NCT02548832 | Completed Phase 3 Results

• 1 other identifier: EABYBL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Mixed Dyslipidemia

Keywords

Berberine; Bezafibrate

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  90 days

Secondary Outcomes (8)

• Body Weight (BW) After 90 Days

  90 days

• Body Mass Index (BMI) After 90 Days

  90 days

• Waist Circumference (WC) After 90 Days

  90 days

• Systolic Blood Pressure After 90 Days

  90 days

• Diastolic Blood Pressure After 90 Days

  90 days

Study Arms (3)

Berberine

EXPERIMENTAL

Berberine 500 mg with breakfast, meal, and dinner.

Drug: Berberine

Bezafibrate

EXPERIMENTAL

Bezafibrate 200 mg on breakfast and dinner.

Drug: Bezafibrate

Berberine plus Bezafibrate

EXPERIMENTAL

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

Drug: Berberine plus Bezafibrate

Interventions

Berberine 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.

Berberine

Bezafibrate 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.

Bezafibrate

Berberine plus Bezafibrate 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.

Also known as: Berberine, bezafibrate

Berberine plus Bezafibrate

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Interventions

Berberine; Bezafibrate

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Benzamides; Amides; Organic Chemicals; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzoates; Acids, Carbocyclic; Chlorobenzoates; Phenyl Ethers; Ethers; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Limitations and Caveats

Time of intervention and the sample size.

Results Point of Contact

• Title: Esperanza Martinez Abundis
• Organization: INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA

esperanzamartnezabundi@yahoo.com

3310585200

Study Officials

• Esperanza Martínez-Abundis

  INTEC, CUCS, University of Guadalajara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Someone of the team make a key number for each patient (36 enrolled, 12 for each intervention), and then put the numbers in to 36 paper envelopes and let the patient chose one. There was double-blind. And the placebo was calcined magnesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Esperanza Martínez-Abundis

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 14, 2015
• Study Start: April 1, 2013
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: February 24, 2023
• Results First Posted: February 24, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)