Overview

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

Status:
Unknown status
Trial end date:
2016-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Guadalajara
Treatments:
Bezafibrate
Magnesium Oxide
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> 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%.

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