HypertensionHyGutNCT06284928
Metagenomic Analysis of Gut Microbiota in Untreated and Uncontrolled Hypertensive Patients
An observational study of Hypertension and Gut Microbiota, run by Xinjiang Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Gut Microbiota
- What is being tested?
- Fecal Sample Collection
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- General Inclusion (applies to all participants)
- Adults aged 18 years or older.
- Able and willing to provide a stool sample for gut microbiota analysis.
- Able to understand and sign written informed consent prior to participation.
- Cohort-Specific Inclusion
- Untreated Hypertension Group (Newly Diagnosed)
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- 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.
- Never received any antihypertensive medication prior to enrollment.
- Uncontrolled Hypertension Group (On Medication)
- Established hypertension, under stable antihypertensive therapy for ≥4 weeks.
- 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).
- No planned medication changes until stool sampling is completed.
- Healthy Control Groups
- No history of hypertension or antihypertensive medication use.
- Office BP <130/80 mmHg (average of 2-3 readings).
- Free from major chronic or gastrointestinal diseases.
Who cannot join
- Use of antibiotics, probiotics, or prebiotics within the previous 3 months, or bowel preparation for colonoscopy within 4 weeks.
- Chronic gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome, celiac disease) or history of major gastrointestinal surgery (including bariatric surgery).
- 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.
- Pregnancy or lactation.
- Acute infection, acute gastrointestinal symptoms, or hospitalization within the past 4 weeks.
- Special restrictive diets (e.g., ketogenic, elimination, or medically prescribed weight-loss diets) or alcohol/substance abuse that may alter gut microbiota.
- Any other condition that, in the investigator's opinion, could interfere with participation, data integrity, or sample quality.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 630000
About this study
Official title: 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.
- Conditions
- Hypertension, Gut Microbiota
- Being tested
- Fecal Sample Collection
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Sample CollectionOther
Non-invasive stool sample collection for gut microbiota metagenomic analysis. No drug or behavioral intervention involved.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fecal Sample Collection | |
| 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. Receives: Other: Fecal Sample Collection | |
| 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. Receives: Other: Fecal Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiota Composition Differences Between Hypertensive and Healthy Individuals
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.
Measured: Samples will be collected and analyzed once within the cross-sectional study period .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Dec 2019
- Primary completion1 Jun 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Xie, Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284928
- Sponsor's protocol ID
- 20240104-01
- Acronym
- HyGut
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2024
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Microbial Patterns in Hypertension: A Cross-Sectional Analysis of Gut Microbiota in Newly Diagnosed Patients (MIPHYP-CROSS Study)
- ClinicalTrials.gov ID
- NCT06284928
- Acronym / sponsor ID
- HyGut / 20240104-01
- Conditions
- Hypertension, Gut Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Untreated Hypertension Group | – | Other: Fecal Sample CollectionThis 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. |
| Uncontrolled Hypertension Group | – | Other: Fecal Sample CollectionThis 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. |
| Healthy Control Group | – | Other: Fecal Sample CollectionThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- General Inclusion (applies to all participants)
- Adults aged 18 years or older.
- Able and willing to provide a stool sample for gut microbiota analysis.
- Able to understand and sign written informed consent prior to participation.
- Cohort-Specific Inclusion
Key exclusion criteria (7 listed)
- Use of antibiotics, probiotics, or prebiotics within the previous 3 months, or bowel preparation for colonoscopy within 4 weeks.
- Chronic gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome, celiac disease) or history of major gastrointestinal surgery (including bariatric surgery).
- 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.
- Pregnancy or lactation.
- Acute infection, acute gastrointestinal symptoms, or hospitalization within the past 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Sample CollectionNon-invasive stool sample collection for gut microbiota metagenomic analysis. No drug or behavioral intervention involved. | Other | Healthy Control Group, Uncontrolled Hypertension Group, Untreated Hypertension Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Gut Microbiota, run by Xinjiang Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiota Composition Differences Between Hypertensive and Healthy Individuals (time frame: Samples will be collected and analyzed once within the cross-sectional study period .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.