KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Lipid trafficking score LT-Mo
研究概览
简要总结
A majority of high-risk patients does not achieve their cholesterol target levels and most of these patients do not receive more effective combination therapy, which goes beyond statin monotherapy. Large interindividual differences in treatment outcomes have been observed for patients receiving statins. Statins block cholesterol synthesis and increase cellular low-density lipoprotein (LDL) uptake. Importantly, LDL uptake is highly divergent in individuals.The aim of this trial is to investigate how atorvastatin influences leukocyte readouts of LDL uptake and lipid storage in humans. The trial is a single-arm, open-label, interventional trial. A total of 15 healthy volunteers will receive 40 mg atorvastatin once a day for 4 weeks. The participants will provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin, and one week after the end of the intervention for the measurement of leukocyte readouts of LDL uptake and lipid storage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a signed written informed consent
- •age 18-40 years
- •healthy, and
- •Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
- •Fully vaccinated against COVID-19.
排除标准
- •significant disease
- •SLCO1B1 poor function genotype
- •oral contraception or other continuous medication
- •pregnancy, planning of pregnancy or breastfeeding
- •participating in a clinical trial less than 3 months ago
- •donating blood less than 3 months ago
- •marked obesity
- •anticipated difficulties in drawing blood samples
- •weight less than 45 kg
- •BMI less than 18.5 kg/m2 or
- •inadequate Finnish language skills
研究组 & 干预措施
Atorvastatin
atorvastatin 40 mg daily for 28 days
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Lipid trafficking score LT-Mo
时间窗: Baseline and once a week for 5 weeks
The primary outcome measurement is the "lipid trafficking score LT-Mo" is a combination of LDL uptake and lipid droplet quantifications in monocytes. The participants provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin (4 times in total), and one week after the end of the intervention.
次要结局
- Leukocyte LDL uptake(Baseline and once a week for 5 weeks)
- Atorvastatin plasma concentration(Once a week during the 4 week atorvastatin treatment)
- Leukocyte lipid storage(Baseline and once a week for 5 weeks)
研究者
Mikko Niemi
Professor
Helsinki University Central Hospital