How Atorvastatin Affects the Gut Flora and Metabolomics?

December 30, 2019 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yue Wu, Professor
  • Phone Number: 18092826334
  • Email: imyuewu@qq.com

Study Contact Backup

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China
        • Recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Atorvastatin regulates intestinal flora
Drug: Atorvastatin 20 Mg Oral Tablet
Atorvastatin 20mg oral once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of flora
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Chair: Zuyi Yuan, Professor, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2017

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

December 30, 2019

First Posted (ACTUAL)

January 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2018LSK-91

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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