Clinical trial NCT06284928: Gut Microbiota and New Hypertension
Official title: Microbial Patterns in Hypertension Discovery: A Cross-Sectional Analysis of Gut Microbiota in Newly Diagnosed Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Gut Microbiota
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study Population Description:

The study includes adults aged 18 and above, consisting of two groups:

Hypertension Group: Adults with confirmed hypertension (systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) diagnosed via medical records or recent examination.

Control Group: Adults without hypertension, serving as a comparison group to assess gut microbiota differences.

Both groups are willing to provide fecal samples and provide informed consent. The study aims to analyze and compare their gut microbiota to identify hypertension-related microbial patterns.

Brief summary: This study aims to explore the gut microbiota patterns in patients newly diagnosed with hypertension, comparing them to those in non-hypertensive individuals. Utilizing cross-sectional analysis, it seeks to identify specific microbial profiles associated with hypertension, which could provide insights into the disease's pathogenesis and potential new avenues for treatment. The research focuses on analyzing fecal samples collected from both groups, using advanced genomic techniques to assess the diversity and abundance of gut bacteria. This investigation could contribute significantly to our understanding of the role gut microbiota plays in cardiovascular health and disease.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and above.
* Newly diagnosed with hypertension, defined as having a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, confirmed by medical records or a recent health examination.
* Willing to provide a fecal sample for microbiota analysis.
* Able to give informed consent.
* Have not undergone any pharmacological treatment.

Exclusion Criteria:

* Individuals with a history of chronic gastrointestinal diseases, such as inflammatory bowel disease or irritable bowel syndrome, which could independently affect gut microbiota.
* Use of antibiotics, probiotics, or prebiotics within the last three months, as these can alter the natural state of the gut microbiota.
* Presence of other significant chronic diseases like diabetes, severe renal or liver diseases, or heart failure.
* Pregnancy, as it can lead to physiological changes influencing gut microbiota.
* History of bariatric surgery or any other major gastrointestinal surgery.
* Currently on medications known to significantly affect blood pressure other than standard antihypertensive treatments.

Primary outcomes:
measure: Change in Gut Microbiota Composition
timeFrame: The assessment of the primary outcome measure will be conducted within 1 month of sample collection, which is a cross-sectional analysis.
Secondary outcomes:
Other outcomes:
Locations:
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References: