Gut Microbiota and New Hypertension

Hypertension Clinical Trial

— MIPHYP-CROSS  

Official title:

Microbial Patterns in Hypertension Discovery: A Cross-Sectional Analysis of Gut Microbiota in Newly Diagnosed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06284928
• Other study ID #: 20240104-01
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2024
• Source: Xinjiang Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gut Microbiota
• Hypertension

Intervention

Other:
• Gut Microbiota Analysis
This refers to the procedure of collecting fecal samples from both the hypertension group and the control group, followed by analyzing these samples to assess and compare the gut microbiota composition using methods like gene sequencing.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Xinjiang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gut Microbiota Composition	Change in gut microbiota composition, including alterations in bacterial taxa, diversity, and abundance, between newly diagnosed hypertension patients and non-hypertensive control individuals.	The assessment of the primary outcome measure will be conducted within 1 month of sample collection, which is a cross-sectional analysis.