Effect of Administration of the Combination Bezafibrate More Berberine on Lipid Profile in Patients With Dyslipidemia

• Sponsor: University of Guadalajara (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02548832
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Duration (Months): 39
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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 and reduced HDL-C as part of the elements for classification, which includes mixed dyslipidemia.

Currently fibrates, such as bezafibrate, are drugs whose utility in treating hypertriglyceridemia is fully proven, 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 the bezafribrato in the treatment of mixed dyslipidemia and as an option with lower cost and lower frequency of adverse events.

Condition or Disease	Intervention/Treatment	Phase
Mixed Dyslipidemia	Drug: Berberine; Drug: Bezafibrate; Drug: Placebo; Drug: Placebo	Phase 2

Detailed Description

Clinical trial, double-blind, simple random assignment and parallel groups. Three study groups of patients will be between 30-60 years of age diagnosed with mixed dyslipidemia with failure to control medical nutrition therapy, which by simple random assignment with random numbers will be assigned to one of three groups:

1. 20 patients will receive berberine, 1500 mg / day

2. Patients receive 20 bezafibrate 400 mg / day

3. 20 patients will receive combination of berberine (1500 mg / day) plus bezafibrate (400 mg / day) They were determined before and after the intervention: lipid profile (total cholesterol, triglycerides, HDL-C, LDL-C, VLDL), weight, BMI, waist circumference, glucose, blood pressure, tolerability.

Statistical analysis was performed upon the sample of subjects. Before starting 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Administration of the Combination Bezafibrate More Berberine on Lipid Profile in Patients With Mixed Dyslipidemia
• Study Start Date: Apr 1, 2013
• Anticipated Primary Completion Date: May 1, 2016
• Anticipated Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Berberine more Placebo Men and women aged 30 to 60 years with an established diagnosis of mixed dyslipidemia: total cholesterol> 200 mg / dL, triglycerides> 150 mg / dL	Drug: Berberine; Berberine capsules, 500 mg 3 times daily with the first bite of each meal; Drug: Placebo; Placebo capsules, 200 mg 2 times daily with the first bite of each meal; Other Names: Magnesia
Active Comparator: Bezafibrate more placebo Men and women aged 30 to 60 years with an established diagnosis of mixed dyslipidemia: total cholesterol> 200 mg / dL, triglycerides> 150 mg / dL	Drug: Bezafibrate; Bezafibrate capsules, 200 mg 2 times daily with the first bite of each meal; Drug: Placebo; Placebo capsules, 500 mg 3 times daily with the first bite of each meal; Other Names: Magnesia
Experimental: Berberine more Bezafibrate Men and women aged 30 to 60 years with an established diagnosis of mixed dyslipidemia: total cholesterol> 200 mg / dL, triglycerides> 150 mg / dL	Drug: Berberine; Berberine capsules, 500 mg 3 times daily with the first bite of each meal; Drug: Bezafibrate; Bezafibrate capsules, 200 mg 2 times daily with the first bite of each meal

Outcome Measures

Primary Outcome Measures

1. Total cholesterol [90 days]

   Before and after intervention by spectrophotometry

2. Triglycerides [90 days]

   Before and after intervention by spectrophotometry

3. High density lipoprotein cholesterol [90 days]

   Before and after intervention by spectrophotometry

4. Low density lipoprotein [90 days]

   Before and after intervention by Friedewall formula

5. Very low density lipoprotein [90 days]

   Before and after intervention by Friedewall formula

Secondary Outcome Measures

1. Body weight [90 days]

   Before and after intervention by

2. Body mass index [90 days]

   Before and after intervention by

3. Waist circumference [90 days]

   Before and after intervention

4. Fasting glucose [90 days]

   Before and after intervention

5. Blood pressure [90 days]

   Before and after intervention

6. Alanine aminotransferasa [90 days]

   Before and after intervention

7. Aspartate aminotransferase [90 days]

   Before and after intervention

8. Creatinine [90 days]

   Before and after intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Men and women B. Accomplished age 30 to 60 years

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

• Total cholesterol> 200 mg / dL

• Triglycerides> 150 mg / dL 27 D. BMI of 25 kg / m2 to 39.9 kg / m2, weight stable over the past three months, defined as a variability in the lower body weight of 5%.

1. 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:

1. 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
2. Intolerance or not tolerability or hypersensitivity to the compounds used in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco	Mexico	44340

Sponsors and Collaborators

• University of Guadalajara

Investigators

• Principal Investigator: Esperanza Martínez-Abundis, PhD, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Esperanza Martínez-Abundis, PhD. Esperanza Martínez-Abundis, University of Guadalajara
• ClinicalTrials.gov Identifier: NCT02548832
• Other Study ID Numbers: EABYBL
• First Posted: Sep 14, 2015
• Last Update Posted: Sep 14, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Esperanza Martínez-Abundis, PhD. Esperanza Martínez-Abundis, University of Guadalajara: Berberine; Bezafibrate
• Additional relevant MeSH terms: Dyslipidemias; Magnesium Oxide; Bezafibrate

Study Results

No Results Posted as of Sep 14, 2015