Gut Organoid and Microbiome Interactions in Hypertension

NCT04497727 | Completed Results

• 2 other identifiers: IRB201903360 -NR01HL132448
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The study compared basic properties of gut epithelia of hypertensive and normotensive reference subjects. The study determined if there are fundamental differences in the gut epithelium in hypertension compared to normotension. Specifically, this study examined gene expression profiles of gut organoids derived from biopsy samples of hypertensive and normotensive individuals undergoing clinically indicated colonoscopy.

Conditions

Gut Inflammation; Hypertension

Outcome Measures

Primary Outcomes (2)

• Differential Gene Expression in Gut Epithelium

  Number of differentially expressed genes identified through RNA sequencing of colonic epithelial tissue obtained during colonoscopy. Expression profiles were compared between individuals with High Blood pressure (HBP) (hypertensive group) and normotensive reference (REF) participants. Genes were considered differentially expressed if they met criteria of false discovery rate (FDR)-adjusted p-value \< 0.05 and absolute fold change ≥ 1.5.

  At time of colonoscopy (single visit)

• Growth Rates of Gut Organoids

  To compare growth rates and proportions of gut organoids derived from High Blood pressure (HBP) vs. normotensive (REF) participants.

  Within days to weeks post-biopsy (in vitro culture period)

Study Arms (1)

Patients undergoing routine colonoscopy

Participants were adults undergoing routine screening colonoscopy who met study eligibility criteria and provided written informed consent. Based on their blood pressure status, participants were categorized into two groups: individuals without hypertension (normotensive group) and individuals with high blood pressure (hypertensive group), defined according to the 2017 ACC/AHA guidelines

Other: Gene Expression

Interventions

Gene Expression OTHER

Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination

Patients undergoing routine colonoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hypertensive and normotensive patients who routinely undergo scheduled elective colonoscopy (for different, not selected reasons)

You may not qualify if:

• Ages: 18-80 years old with a weight greater than or equal to 110 lbs
• Diagnosis of hypertension or without hypertension for the reference cohort. 2017 ACC/AHA (American College of Cardiology/American Heart Association) definition for hypertension (systolic blood pressure ≥130 mmHg and/or diastolic BP ≥80 mmHg) will be used.
• Scheduled elective colonoscopy
• Hypertensive or reference individuals with history of autoimmune disease or other chronic inflammatory conditions.
• Pregnant or have been pregnant in the last six months.
• Antibiotic treatment within two months of study enrollment
• Currently taking a medication (e.g. antibiotic, anti-inflammatory agents, glucocorticoids, other immune modulating medications, antacids or proton pump inhibitor drugs like Prilosec) known to modify gut microbiota.
• Unwilling to discontinue using probiotics for at least two weeks before scheduled biopsy.
• History of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
• History of blood transfusion within 4 weeks.
• Subjects who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures

Sponsors & Collaborators

• University of Florida: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

During your scheduled colonoscopy, a maximum of 4 biopsies will be taken from your colon.

MeSH Terms

Conditions

Hypertension

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Results Point of Contact

• Title: Dr. Carl J. Pepine
• Organization: University of Florida

carl.pepine@medicine.ufl.edu

(352) 339-0696

Study Officials

• Carl Pepine

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 4, 2020
• Study Start: March 5, 2021
• Primary Completion: April 8, 2022
• Study Completion: April 21, 2024
• Last Updated: September 29, 2025
• Results First Posted: September 29, 2025

Record last verified: 2025-08

Locations

US (1)