How Atorvastatin Affects the Gut Flora and Metabolomics?

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: Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Drug: Atorvastatin 20 Mg Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	4 months

Collaborators and Investigators

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

Study record dates

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: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• 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