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NCT03808740 · ClinicalTrials.gov registry record · Phase 1
Orthostatic Intolerance After Bariatric Surgery
A Phase 1 study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03808740 is a Phase 1 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT03808740, a Phase 1 study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
More than 78 million adults in the U.S. are obese. Bariatric surgery is the only modality that results in sustained weight loss along with reversal of diabetes mellitus, and a decrease in cardiovascular events. Obesity is associated with increased sympathetic nervous system (SNS) activity that contributes to blood pressure regulation; sympathetic vasoconstrictor activity is maximally activated upon standing and is fundamental for the maintenance of orthostatic tolerance. After bariatric surgery, there is a significant and sustained reduction in SNS activity at three and six months after the procedure, which is related to weight loss. Recently, multiple retrospective studies have reported an orthostatic intolerance (OI) syndrome after bariatric surgery characterized by chronic pre-syncopal symptoms, syncope and orthostatic hypotension. In the Vanderbilt University Medical Center bariatric surgical center, 741 post-bariatric surgery patients reported OI symptoms, 98 (13.2%) of these patients, progressed to chronic OI and in17 cases, the OI was so disabling that patients initiated treatment with pressor agents. More than 50% of OI cases in the cohort developed the condition during a weight-stable period. Hence, investigators propose the novel hypothesis that after bariatric surgery, the persistent reduction in SNS activity contributes to impaired orthostatic tolerance, which is independent of weight loss.
Interventions
- DRUG Placebo
- DRUG Atomoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03808740
The ClinicalTrials.gov registry entry for NCT03808740 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03808740 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03808740 about?
NCT03808740 is a clinical study titled "Orthostatic Intolerance After Bariatric Surgery". More than 78 million adults in the U.S. are obese. Bariatric surgery is the only modality that results in sustained weight loss along with reversal of diabetes mellitus, and a decrease in cardiovascular events. Obesity is associated with increased sympathetic nervous system (SNS) activity that contr...
What is the current status of trial NCT03808740?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2018-07-01. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT03808740?
The interventions under investigation include: Placebo (DRUG), Atomoxetine (DRUG).
Who is sponsoring clinical trial NCT03808740?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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