Trial Outcomes & Findings for Gut Organoid and Microbiome Interactions in Hypertension (NCT NCT04497727)
NCT ID: NCT04497727
Last Updated: 2025-09-29
Results Overview
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.
COMPLETED
35 participants
At time of colonoscopy (single visit)
2025-09-29
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
19
|
|
Overall Study
COMPLETED
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gut Organoid and Microbiome Interactions in Hypertension
Baseline characteristics by cohort
| Measure |
Hypertensive Group
n=16 Participants
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
|
Normotensive Group
n=19 Participants
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
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 Years
n=99 Participants
|
55 Years
n=107 Participants
|
58 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At time of colonoscopy (single visit)Population: Colonic biopsies from HBP participants revealed 35 differentially expressed genes (29 upregulated, 6 downregulated) compared to normotensive subjects (reference group).
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.
Outcome measures
| Measure |
All Study Participants
n=35 Participants
Participants were adults undergoing routine screening colonoscopy who met study eligibility criteria and provided written informed consent.
|
|---|---|
|
Differential Gene Expression in Gut Epithelium
Upregulated Genes
|
29 Differentially expressed gene
|
|
Differential Gene Expression in Gut Epithelium
Downregulated Genes
|
6 Differentially expressed gene
|
PRIMARY outcome
Timeframe: Within days to weeks post-biopsy (in vitro culture period)Population: 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.
To compare growth rates and proportions of gut organoids derived from High Blood pressure (HBP) vs. normotensive (REF) participants.
Outcome measures
Outcome data not reported
Adverse Events
Hypertensive Group
Normotensive Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place