Metagenomic Analysis of Gut Microbiota in Untreated and Uncontrolled Hypertensive Patients (HyGut)

December 28, 2025 updated by: Xiang Xie, Xinjiang Medical University

Exploration of Microbial Patterns in Hypertension: A Cross-Sectional Analysis of Gut Microbiota in Newly Diagnosed Patients (MIPHYP-CROSS Study)

This observational study aims to explore the relationship between gut microbiota composition and blood pressure regulation in patients with hypertension. A total of 192 participants will be enrolled, including newly diagnosed untreated hypertensive patients, patients with uncontrolled hypertension under medication, and healthy controls. Fecal samples will be collected for metagenomic sequencing to identify microbial taxa and functional pathways associated with blood pressure levels. The findings are expected to reveal characteristic microbial patterns linked to hypertension and provide potential microbial targets for improving antihypertensive therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Contacts and Locations

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

Study Locations

  • China
    • Xinjiang
      • Ürümqi, Xinjiang, China, 630000
        • The First Affiliated Hospital of Xinjiang Medical 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adults aged 18 years or older recruited from the outpatient clinics and health examination centers of the First Affiliated Hospital of Xinjiang Medical University. Participants include three groups: newly diagnosed untreated hypertensive patients, hypertensive patients receiving medication but with uncontrolled blood pressure, and healthy controls without hypertension or major chronic diseases. All participants will provide stool samples for gut microbiota metagenomic analysis and basic clinical data collection.

Description

Inclusion Criteria

General Inclusion (applies to all participants)

  1. Adults aged 18 years or older.
  2. Able and willing to provide a stool sample for gut microbiota analysis.
  3. Able to understand and sign written informed consent prior to participation.

Cohort-Specific Inclusion

A. Untreated Hypertension Group (Newly Diagnosed)

  1. Newly diagnosed hypertension, defined as: Office blood pressure ≥140/90 mmHg, confirmed by at least two measurements on separate visits; or 24-hour ambulatory BP monitoring (ABPM): mean ≥130/80 mmHg, or daytime ≥135/85 mmHg, or nighttime ≥120/70 mmHg.
  2. Never received any antihypertensive medication prior to enrollment.

B. Uncontrolled Hypertension Group (On Medication)

  1. Established hypertension, under stable antihypertensive therapy for ≥4 weeks.
  2. Blood pressure not at target, defined as: Office BP ≥140/90 mmHg, or 24-hour ABPM mean ≥130/80 mmHg (daytime ≥135/85 mmHg, nighttime ≥120/70 mmHg).
  3. No planned medication changes until stool sampling is completed.

C. Healthy Control Groups

  1. No history of hypertension or antihypertensive medication use.
  2. Office BP <130/80 mmHg (average of 2-3 readings).
  3. Free from major chronic or gastrointestinal diseases.

Exclusion Criteria

  1. Use of antibiotics, probiotics, or prebiotics within the previous 3 months, or bowel preparation for colonoscopy within 4 weeks.
  2. Chronic gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome, celiac disease) or history of major gastrointestinal surgery (including bariatric surgery).
  3. Presence of major chronic diseases that may confound gut microbiota or blood pressure regulation, including: Coronary artery disease (CAD) or other significant cardiovascular diseases; Diabetes mellitus (type 1 or type 2); Chronic kidney disease (stage ≥3); Chronic liver disease or hepatic failure; Heart failure (NYHA class III-IV); Active malignancy or history of cancer within the past 5 years.
  4. Pregnancy or lactation.
  5. Acute infection, acute gastrointestinal symptoms, or hospitalization within the past 4 weeks.
  6. Special restrictive diets (e.g., ketogenic, elimination, or medically prescribed weight-loss diets) or alcohol/substance abuse that may alter gut microbiota.
  7. Any other condition that, in the investigator's opinion, could interfere with participation, data integrity, or sample quality.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Untreated Hypertension Group
This cohort includes participants who have been newly diagnosed with hypertension and have not received any antihypertensive therapy. They serve as the primary population for exploring gut microbiota characteristics associated with the onset of hypertension.
Other: Fecal Sample Collection
Non-invasive stool sample collection for gut microbiota metagenomic analysis. No drug or behavioral intervention involved.
Uncontrolled Hypertension Group
This cohort includes participants with hypertension who are receiving antihypertensive medication but whose blood pressure remains above target levels. They are enrolled to examine gut microbiota patterns associated with poor blood pressure control despite treatment.
Other: Fecal Sample Collection
Non-invasive stool sample collection for gut microbiota metagenomic analysis. No drug or behavioral intervention involved.
Healthy Control Group
This cohort includes healthy adult participants with normal blood pressure (office BP <130/80 mmHg) and no history of hypertension, cardiovascular, metabolic, or gastrointestinal diseases. They serve as the reference population for comparative analyses of gut microbiota composition and function against both untreated and uncontrolled hypertensive patients.
Other: Fecal Sample Collection
Non-invasive stool sample collection for gut microbiota metagenomic analysis. No drug or behavioral intervention involved.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gut Microbiota Composition Differences Between Hypertensive and Healthy Individuals
Time Frame: Samples will be collected and analyzed once within the cross-sectional study period .
Comparative analysis of gut microbiota composition, including bacterial diversity, relative abundance, and taxonomic profiles, between newly diagnosed untreated hypertensive patients and non-hypertensive healthy controls. Metagenomic sequencing will be used to identify microbial taxa and functional pathways associated with blood pressure status.
Samples will be collected and analyzed once within the cross-sectional study period .

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinjiang Medical 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20240104-01

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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