Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c
研究概览
简要总结
Berberine is a dietary supplement that comes from the roots, stems, and bark of various plants and has been used for centuries in traditional Chinese medicine. It may help lower cholesterol, lower blood sugar, and reduce inflammation.Very few studies have been done in the United States to show how berberine effects cholesterol and blood sugar. This study is looking to see how berberine changes cholesterol and blood sugar, and to see how well it is tolerated.Berberine is not a prescription medication but it appears to have similar actions to common prescription medications to lower cholesterol like statins, and to lower blood sugar like metformin. We are studying berberine to see if it may be a good option for people that do not want to take prescription medications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and older
- •Current LDL-C of ≥80 mg/dL or higher
- •Current fasting triglyceride level of ≥300 mg/dL
- •Meets current criteria for metabolic syndrome (≥3 of the following):
- •Waist circumference ≥ 35" female or ≥40" for male:
- •Triglycerides ≥ 150 mg/dL:
- •Low HDL-c <40 mg/dL male or <50 mg/dL female:
- •Elevated blood pressure ≥ 130/85 mmHg (or on BP medication):
- •Elevated fasting blood glucose ≥100 mg/dL
- •A male or a non-pregnant female
- •Mentally competent to understand study rationale and protocol
- •Able to speak and read English
排除标准
- •Currently taking any lipid-altering agents including but not limited to statins, niacin (>500 mg), bile-acid sequestrants, ezetimibe, fibrates, and Omega-3 fish/krill oils (>1000 mg EPA/DHA).
- •Prior evidence of a vascular event (e.g. stroke, myocardial infarction, revascularization, peripheral vascular disease)
- •Current use of any oral hypoglycemia agent or parenteral medication for diabetes mellitus (e.g. GLP-1 agonists, insulin)
- •Currently taking any drugs with the potential to interact with berberine, including but not limited to cyclosporine, simvastatin, lovastatin, metformin, saquinavir, darunavir, tacrolimus, sirolimus.
- •Previous history of diabetes mellitus, HbA1c ≥ 6.5%, or FPG > 126 mg/dL
- •Chronic disease involving, hepatic, renal, or coronary heart disease, systemic infection (e.g. HIV) or organ transplantation
- •Currently taking systemic steroidal drugs
- •Dependence on alcohol (> 10 drinks per week) or illicit drugs
- •Pregnant or lactating
- •Participation in any other clinical trial within the last 30 days
- •Presence of any medical or psychological condition that in the opinion of the investigator will compromise safe subject participation for the duration of the study
- •Acute or chronic GI conditions (e.g. irritable bowel syndrome, ulcerative colitis)
研究组 & 干预措施
Identical Placebo
干预措施: Identical Placebo (Other)
Berberine
干预措施: Berberine (Dietary Supplement)
结局指标
主要结局
Change in Hemoglobin A1c
时间窗: Baseline to week 12
Glucose control as measured by fasting blood sample
Change in LDL Cholesterol
时间窗: Baseline to week 12
LDL cholesterol measured by fasting blood sample
次要结局
- Number of participants with adverse events(Week 4, Week 8, and Week 12)
研究者
James Backes, PharmD
Professor
University of Kansas Medical Center