HypertensionNCT05057039
The Study of Gut Microbiota in Hypertensive Patients
An observational study of Hypertension and Gut Microbiota, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Hypertension, Gut Microbiota, Diet
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2021to 31 Dec 2023
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Study population: People who join the Elderly Health Examination Program in Cathay General Hospital in 2021
Who may be able to join
- Age 65~80 years old
- People who join the Elderly Health Examination Program in Cathay General Hospital in 2021
Who cannot join
- Antibiotics use within one month
- Acute gastrointestinal illness within one week, such as vomiting and diarrhea
- History of gastrointestinal surgery
- History of inflammatory bowel disease
- Chronic gastrointestinal disease under medication treatment
- Cannot finish dietary record
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertension, Gut Microbiota, Diet
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hypertensive group | SBP >=140mmHg, DBP >=90mmHg, or use of antihypertensive drug | |
| normotensive group | SBP <=140mmHg and DBP <=90mmHg without use of antihypertensive drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of gut microbiota composition between the two groups
The differential OTUs (operational taxonomic units) between the two groups
Measured: immediately after the enrollment completes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Sep 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Cathay General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057039
- Sponsor's protocol ID
- CGH-P110063
- Status last verified
- Jan 2023
- First submitted
- 9 Sep 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Gut Microbiota in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT05057039
- Acronym / sponsor ID
- CGH-P110063
- Conditions
- Hypertension, Gut Microbiota, Diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Cathay General Hospital
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Sep 2021 (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.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertensive group | – | –SBP >=140mmHg, DBP >=90mmHg, or use of antihypertensive drug |
| normotensive group | – | –SBP <=140mmHg and DBP <=90mmHg without use of antihypertensive drug |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- People who join the Elderly Health Examination Program in Cathay General Hospital in 2021
Key inclusion criteria (2 listed)
- Age 65~80 years old
- People who join the Elderly Health Examination Program in Cathay General Hospital in 2021
Key exclusion criteria (6 listed)
- Antibiotics use within one month
- Acute gastrointestinal illness within one week, such as vomiting and diarrhea
- History of gastrointestinal surgery
- History of inflammatory bowel disease
- Chronic gastrointestinal disease under medication treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference of gut microbiota composition between the two groups
Time frame: immediately after the enrollment completes
The differential OTUs (operational taxonomic units) between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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 Taipei Medical University at 1 site in Taiwan.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. 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 Taiwan. 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?
Results are not available in the source record.
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?
The difference of gut microbiota composition between the two groups (time frame: immediately after the enrollment completes). 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 18 Apr 2023.