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How Atorvastatin Affects the Gut Flora and Metabolomics?

A Clinical Observational Trail on Atorvastatin Regulates Intestinal Flora and Metabolomics.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04215237
Enrollment
30
Registered
2020-01-02
Start date
2017-11-13
Completion date
2021-06-01
Last updated
2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Cardiovascular Disease

Brief summary

Recent studies suggest that gut microbiome, the microbial community in the intestine, may directly and indirectly influence the progression of atherosclerosis. The imbalance of gut microbiome may directly promote the formation of atherosclerotic plaques by promoting the inflammatory reaction and oxidative stress affecting vascular endothelial function and increasing platelet activity. Meanwhile, it can indirectly increase the risk of atherosclerosis by enhance insulin resistance, reducing the production of bile acids and raising serum LDL-C and angiotensin levels. As shown in these researches, gut microbiome, acting as a bridge between metabolism, energy and inflammatory responses, may play an important role in cardiovascular diseases, and we believe that the interaction between microbiome and host should be considered in the ASCVD study.

Interventions

Atorvastatin 20mg oral once a day

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-80 years; * Statin indications such as lipid metabolism disorders, diabetes, elevated CRP, atherosclerosis; stratification according to ASCVD risk; indications for statin treatment * Not using statins and other lipid-lowering drugs for at least 6 months before enrollment; * Agree to receive research treatment plan; * Voluntarily sign the informed consent.

Exclusion criteria

* People with active gastrointestinal bleeding or have a clear history of gastrointestinal ulcers or bleeding in the past 2 years; * Severe renal insufficiency (eGFR \<30ml / min / 1.73m2); * Active hepatitis, liver cirrhosis, or ALT increase more than 3 times; * Those with severe hypertension (\> 180 / 110mmHg) and currently have no control; * Hemoglobin \<100g / L; * Platelet count \<100 × 109 cells / L; * Suffering from a known serious progressive disease (such as a malignant tumor) or a disease that causes the patient to fail extremely, the estimated survival time is \<12 months; * pregnant or intending to become pregnant; * Any situation that may interfere with the research process, such as dementia, paralysis, alcoholism, etc .; * Expected to undergo surgery within 1 year; * Patients participating in other ongoing clinical studies.

Design outcomes

Primary

MeasureTime frame
Number of flora4 months

Countries

China

Contacts

Primary ContactYue Wu, Professor
imyuewu@qq.com18092826334
Backup ContactXiang Hao
drhaoxiang@163.com15877383294

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026