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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL132448 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gene Expression | Other | Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Hypertensive and normotensive patients who routinely undergo scheduled elective colonoscopy (for different, not selected reasons)
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| Name | Affiliation | Role |
|---|---|---|
| Carl Pepine | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertensive Group | 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 as individuals with high blood pressure (hypertensive group), defined according to the 2017 ACC/AHA guidelines |
| FG001 | Normotensive Group | 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 as individuals without hypertension (normotensive group) defined according to the 2017 ACC/AHA guidelines Gene Expression: Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypertensive Group | 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 as individuals with high blood pressure (hypertensive group), defined according to the 2017 ACC/AHA guidelines Gene Expression: Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Colonic biopsies from HBP participants revealed 35 differentially expressed genes (29 upregulated, 6 downregulated) compared to normotensive subjects (reference group). | Posted | Number | Differentially expressed gene | At time of colonoscopy (single visit) |
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From time of colonoscopy procedure through discharge from the recovery area, for an average total duration of approximately 60 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypertensive Group | 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 as individuals with high blood pressure (hypertensive group), defined according to the 2017 ACC/AHA guidelines Gene Expression: Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carl J. Pepine | University of Florida | (352) 339-0696 | carl.pepine@medicine.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2021 | Jun 4, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 4, 2021 | May 9, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
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| D015870 | Gene Expression |
| ID | Term |
|---|---|
| D055614 | Genetic Phenomena |
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During your scheduled colonoscopy, a maximum of 4 biopsies will be taken from your colon.
| BG001 | Normotensive Group | 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 as individuals without hypertension (normotensive group), defined according to the 2017 ACC/AHA guidelines |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Primary | Growth Rates of Gut Organoids | To compare growth rates and proportions of gut organoids derived from High Blood pressure (HBP) vs. normotensive (REF) participants. | No data obtained for this outcome measure because organoid preparations did not meet feasibility criteria for sample quantity and quality required for FACS and IHC. Further samples will never be obtained. | Posted | Within days to weeks post-biopsy (in vitro culture period) |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Normotensive Group | 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 as individuals without hypertension (normotensive group), defined according to the 2017 ACC/AHA guidelines Gene Expression: Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination | 0 | 19 | 0 | 19 | 0 | 19 |
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