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NCT05000996 · ClinicalTrials.gov registry record
Gut Microbiota in Metabolic Surgery
A clinical trial of Hypertension and Cardiovascular Diseases, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- 300
- Enrollment target
- 1
- Study location
NCT05000996 is a study of Hypertension and Cardiovascular Diseases that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 300 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05000996, a study of Hypertension and Cardiovascular Diseases, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.
Conditions Studied
Interventions
- PROCEDURE Bariatric Surgery
Study Locations (1)
Tennessee
- Vanderbilt_University MC - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-08-19 |
| Est. Completion | 2035-01-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05000996
The ClinicalTrials.gov registry entry for NCT05000996 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (91% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Bariatric Surgery is the first listed.
NCT05000996 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT05000996 about?
NCT05000996 is a clinical study titled "Gut Microbiota in Metabolic Surgery". Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined ...
What is the current status of trial NCT05000996?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2021-08-19. Estimated completion is 2035-01-01.
What conditions does trial NCT05000996 study?
This clinical trial studies the following conditions: Hypertension, Cardiovascular Diseases, Type 2 Diabetes, Bariatric Surgery Candidate, Dyslipidemias.
What interventions are being tested in trial NCT05000996?
The interventions under investigation include: Bariatric Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT05000996?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05000996 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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