Effect of Berberine Plus Bezafibrate Administration on the Lipid Profile of Patients With Mixed Dyslipidemia: A Pilot Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Triglycerides After 90 Days
研究概览
简要总结
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.
详细描述
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:
- 12 patients will receive berberine, 1500 mg / day
- 12 Patients will receive bezafibrate 400 mg / day
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Berberine
Berberine 500 mg with breakfast, meal, and dinner.
干预措施: Berberine (Drug)
Bezafibrate
Bezafibrate 200 mg on breakfast and dinner.
干预措施: Bezafibrate (Drug)
Berberine plus Bezafibrate
Berberine 500 mg with breakfast, meal, and dinner, and bezafibrate 200 mg only on breakfast and dinner.
干预措施: Berberine plus Bezafibrate (Drug)
结局指标
主要结局
Triglycerides After 90 Days
时间窗: 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.
Total Cholesterol After 90 Days.
时间窗: 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.
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
时间窗: 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.
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
时间窗: 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.
Very Low Density Lipoprotein After 90 Days
时间窗: 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.
次要结局
- 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)
- Fasting Serum Glucose (FSG) After 90 Days(90 days)
- Uric Acid After 90 Days(90 days)
- Creatinine After 90 Days(90 days)
研究者
Esperanza Martínez-Abundis
Dr. Esperanza Martínez-Abundis
University of Guadalajara