Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in People Living With HIV.
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 主要终点
- Insulin resistance
研究概览
简要总结
With current antiretroviral therapy, people living with HIV reach virological suppression faster, which in turn leads to a higher life expectancy. Nevertheless, this improved survival rate is not free of other comorbidities, such as metabolic syndrome, characterized by a decrease in glucose tolerance and an increase in insulin resistance.
Berberine is an alkaloid that has proven beneficial effects on both glucose tolerance and insulin resistance, but has not been tested in people living with HIV under virological suppression. We hypothesize that berberine will improve inflammatory markers and metabolic profile in this population without significant interactions nor adverse effects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years
- •Documented HIV-1 infection
- •Stable antiretroviral therapy at least 6 months before enrollment
- •Viral suppression
- •Metabolic syndrome , defined by Adult Treatment Panel-III criteria
- •No previously known kidney or liver disease
- •Signed informed consent
排除标准
- •People younger than 18 years and older than 60 years
- •Prior atherosclerotic cardiovascular disease
- •Diabetes mellitus type 1 or 2
- •Previous use of glucose and/or lipid modifying medications
- •Pregnancy
- •Withdrawal of informed consent
研究组 & 干预措施
Placebo
Placebo three times daily for 6 months
干预措施: Placebo (Drug)
Berberine
Berberine 500 mg three times daily for 6 months
干预措施: Berberine (Drug)
结局指标
主要结局
Insulin resistance
时间窗: 24 weeks within randomization
Change from Baseline insulin resistance determined by Homeostasis Model Assessment index, triglyceride to glucose ratio, at 6 months
Change from baseline lipid profile at 6 months
时间窗: At the beginning and 24 weeks within randomization
Measurement of total cholesterol, HDL, LDL, triglycerides.
次要结局
- Inflammatory profile(At the beginning and 24 weeks within randomization)
- Change from baseline weight(At the beginning and 24 weeks within randomization)
研究者
Shaúl Ariel Navarro Lara
Resident
Hospital Civil de Guadalajara