Gut Microbiota and New Hypertension

Completed

• Conditions: Hypertension; Gut Microbiota
• Interventions: Other: Gut Microbiota Analysis

• Registration Number: NCT06284928
• Lead Sponsor: Xinjiang Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-01
• Study First Submitted: 2024-01-30
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Study First Posted: 2024-02-29
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertension Group	Gut Microbiota Analysis	This label would be assigned to the cohort of participants who have been newly diagnosed with hypertension. They are the primary focus of the study to explore the specific patterns in their gut microbiota related to hypertension.
Control Group	Gut Microbiota Analysis	This label would apply to the cohort of participants who do not have hypertension and are otherwise healthy. This group serves as a baseline to compare the microbiota patterns observed in the hypertension group.

Primary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang, China