An observational study in Gut Inflammation and Hypertension, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by University of Florida · Observational
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.
This investigated whether there is a difference in gut epithelia between individuals with and without high blood pressure by comparing colonic biopsy samples from. The study was conducted among adults undergoing routine elective colonoscopy at the University of Florida. Participants were classified into high blood pressure (HBP) and normotensive (REF) groups based on blood pressure criteria defined by the 2017 ACC/AHA guidelines.
The study had two primary aims. Aim 1 was to evaluate whether gene expression patterns in the gut epithelium differ between hypertensive and normotensive individuals using RNA sequencing. Aim 2 was to assess whether gut organoids-three-dimensional epithelial cultures derived from colonic biopsies-exhibit different growth rates and proportions, using immunohistochemistry and fluorescence-activated cell sorting (FACS).
Biopsy specimens were collected during clinically indicated colonoscopies. Tissue samples were processed immediately after collection: one portion was snap-frozen for RNA isolation and sequencing; the other was used to establish gut organoid cultures. Data were coded and stored in a secure, encrypted database with all identifiers removed to protect confidentiality, in compliance with HIPAA regulations.
Although the study protocol initially planned to recruit 60 participants, a total of 35 subjects were successfully enrolled-16 with high blood pressure (HBP) and 19 normotensive (REF) participants. All provided adequate biopsy material for gene expression analysis.
6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.
This study's enrollment of 35 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
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Hypertensive and normotensive patients who routinely undergo scheduled elective colonoscopy (for different, not selected reasons)
Exclusion Criteria:
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
Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination
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.
Time frame: 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.
Time frame: Within days to weeks post-biopsy (in vitro culture period)
| Milestone | Hypertensive Group | Normotensive Group |
|---|---|---|
| Started | 16 | 19 |
| Completed | 16 | 19 |
| Not completed | 0 | 0 |
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.
| Differentially expressed gene | All Study Participants |
|---|---|
| Upregulated Genes | 29 |
| Downregulated Genes | 6 |
To compare growth rates and proportions of gut organoids derived from High Blood pressure (HBP) vs. normotensive (REF) participants.
No measurements were reported for this outcome.
Collected over From time of colonoscopy procedure through discharge from the recovery area, for an average total duration of approximately 60 minutes.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hypertensive Group | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Normotensive Group | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(Years) | Hypertensive Group | Normotensive Group | Total |
|---|---|---|---|
| Mean | 62 (57 to 68) | 55 (50 to 60) | 58 (53 to 65) |
| Sex: Female, Male(Participants) | Hypertensive Group | Normotensive Group | Total |
|---|---|---|---|
| Female | 10 | 15 | 25 |
| Male | 6 | 4 | 10 |
| Race (NIH/OMB)(Participants) | Hypertensive Group | Normotensive Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 11 | 13 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(Participants) | Hypertensive Group | Normotensive Group | Total |
|---|---|---|---|
| United States | 16 | 19 | 35 |
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University of Florida