Actively Recruiting
KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts
Led by Mikko Niemi · Updated on 2024-06-21
15
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
Sponsors
M
Mikko Niemi
Lead Sponsor
U
University of Helsinki
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Age between 18 and 40 years
- Healthy condition
- Acceptable laboratory test results including blood hemoglobin, blood count, platelets, liver enzymes, kidney function, electrolytes, and negative pregnancy test for women
- Fully vaccinated against COVID-19
You will not qualify if you...
- Presence of significant disease
- Smoking
- SLCO1B1 poor function genotype
- Use of oral contraception or other continuous medication
- Pregnancy, planning pregnancy, or breastfeeding
- Participation in another clinical trial within the last 3 months
- Blood donation within the last 3 months
- Marked obesity
- Anticipated difficulties with blood sample collection
- Weight less than 45 kg
- Body mass index less than 18.5 kg/m2
- Inadequate Finnish language skills
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Clinical Pharmacology
Helsinki, Finland, 00290
Actively Recruiting
Research Team
M
Mikko Niemi, MD, PhD
CONTACT
A
Anssi Mykkänen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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