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The Study of Gut Microbiota in Hypertensive Patients

Sponsor
Taipei Medical University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05057039
Collaborator
Cathay General Hospital (Other)
70
Enrollment
1
Location
16
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Recent animal and human studies have found the relationship between the composition of the gut microbiota and hypertension, but some studies did not have a detailed evaluation of the diet content, which could be an important effect on gut microbiota. Moreover, most of these studies were finished in Western countries, in which the dietary patterns were significantly different from those in Chinese regions. This study intends to establish Taiwanese local data to explore the differences in the composition of gut microbiota among hypertensive patients and normotensive subjects.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators plan to enroll total 70 hypertensive and normotensive cases from the elderly health examination in Cathay General Hospital, who are aged from 65 to 80 years. Body mass index and blood samples for biochemical analysis such as blood sugar and cholesterol levels are taken, and fecal samples are collected for analysis of gut microbiota, which is characterized by 16S ribosomal RNA gene sequencing. Besides, the diet and nutrients intake are recorded and calculated by licensed dietitian. Through the exploration of gut microbiota in hypertensive patients, the results can be the reference for clinical treatment.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Study of Gut Microbiota in Hypertensive Patients
    Actual Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    hypertensive group

    SBP >=140mmHg, DBP >=90mmHg, or use of antihypertensive drug
    normotensive group

    SBP <=140mmHg and DBP <=90mmHg without use of antihypertensive drug

    Outcome Measures

    Primary Outcome Measures

    1. The difference of gut microbiota composition between the two groups [immediately after the enrollment completes]

      The differential OTUs (operational taxonomic units) between the two groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age 65~80 years old

    2. People who join the Elderly Health Examination Program in Cathay General Hospital in 2021

    Exclusion Criteria:

    1. Antibiotics use within one month

    2. Acute gastrointestinal illness within one week, such as vomiting and diarrhea

    3. History of gastrointestinal surgery

    4. History of inflammatory bowel disease

    5. Chronic gastrointestinal disease under medication treatment

    6. Cannot finish dietary record

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Medical University Taipei Taiwan 110

    Sponsors and Collaborators

    • Taipei Medical University
    • Cathay General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taipei Medical University
    ClinicalTrials.gov Identifier:
    NCT05057039
    Other Study ID Numbers:
    • CGH-P110063
    First Posted:
    Sep 27, 2021
    Last Update Posted:
    Sep 27, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Sep 27, 2021