Gut Microbiota and New Hypertension (MIPHYP-CROSS)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Gut Microbiota
• Intervention / Treatment: Other: Gut Microbiota Analysis

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Xinjiang
    • Ürümqi, Xinjiang, China, 630000
      • The First Affiliated Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypertension Group; 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.	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.
Control Group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Xinjiang Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 20240104-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No