Trial · NCT03808740
Orthostatic Intolerance After Bariatric Surgery
NCT03808740, Phase 1, Terminated, Vanderbilt University Medical Center; results first posted 2024-09-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Orthostatic Intolerance After Bariatric Surgery. Trials, record NCT03808740. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03808740
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Orthostatic Intolerance After Bariatric Surgery
- NCT number
- NCT03808740
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Orthostatic Intolerance
- Interventions
- Atomoxetine, Placebo
- First posted
- 2019-01-18
- Last updated
- 2024-09-27
- Results first posted
- 2024-09-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | 0- 3 months | To assess the hemodynamic (Blood Pressure) changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients. Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope Orthostatic hemodynamics were analyzed as the area under the curve (AUC) after baseline-correction during HUT. |
| Primary | Cardiac Output During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | 0- 3 months | To assess the hemodynamic (cardiac output \[CO\]) and cardiovascular autonomic changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients. Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope Orthostatic hemodynamics were analyzed as the area under the curve (AUC) after baseline-correction during HUT. |
| Primary | Stroke Volume Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | 0- 3 months | To assess the hemodynamic (stroke volume \[SV\]) and cardiovascular autonomic changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients. Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope Orthostatic hemodynamics were analyzed as the area under the curve (AUC) after baseline-correction during HUT. |
| Primary | Calculated Total Peripheral Resistance During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | 0- 3 months | To assess the hemodynamic ( total peripheral resistance \[TPR\]) and cardiovascular autonomic changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients. Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | 0- 3 months | Orthostatic hemodynamics (SBP, DBP, HR) were analyzed as the area under the curve (AUC) after baseline-correction during HUT | mmHg*hr | MEAN |
| PRIMARY | Cardiac Output During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | 0- 3 months | Orthostatic hemodynamics (Cardiac Output ) were analyzed as the area under the curve (AUC) after baseline-correction during HUT | L/min | MEAN |
| PRIMARY | Stroke Volume Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | 0- 3 months | Orthostatic hemodynamics (Stroke volume) were analyzed as the area under the curve (AUC) after baseline-correction during HUT | mL | MEAN |
| PRIMARY | Calculated Total Peripheral Resistance During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | 0- 3 months | Orthostatic hemodynamics (SBP, DBP, HR) were analyzed as the area under the curve (AUC) after baseline-correction during HUT | mmHg*L/min | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | Pre- Bariatric Participants | Systolic Blood pressure: analyze as Area under the curve (AUC) after baseline-correction during HUT. | 113 | Standard Deviation 72.41 | mmHg*hr |
| Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | Participants After 10% of Weight Loss | Systolic Blood pressure: analyze as Area under the curve (AUC) after baseline-correction during HUT. | 56.02 | Standard Deviation 30.68 | mmHg*hr |
| Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | Participants After 3 Months of the Surgery | Systolic Blood pressure: analyze as Area under the curve (AUC) after baseline-correction during HUT. | 39.4 | Standard Deviation 28.53 | mmHg*hr |
| Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | Pre- Bariatric Participants | Diastolic Blood pressure:analyze as Area under the curve (AUC) after baseline-correction during HUT | 303.7 | Standard Deviation 93.74 | mmHg*hr |
| Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | Participants After 10% of Weight Loss | Diastolic Blood pressure:analyze as Area under the curve (AUC) after baseline-correction during HUT | 60.98 | Standard Deviation 29.54 | mmHg*hr |
| Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | Participants After 3 Months of the Surgery | Diastolic Blood pressure:analyze as Area under the curve (AUC) after baseline-correction during HUT | 39.44 | Standard Deviation 28.53 | mmHg*hr |
| Cardiac Output During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | Pre- Bariatric Participants | 9.124 | Standard Deviation 8.066 | L/min | |
| Cardiac Output During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | Participants After 10% of Weight Loss | 3.562 | Standard Deviation 2.522 | L/min | |
| Cardiac Output During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | Participants After 3 Months of the Surgery | 4.916 | Standard Deviation 3.652 | L/min | |
| Stroke Volume Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months | Pre- Bariatric Participants | 116.2 | Standard Deviation 56.5 | mL |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Baseline (Pre-surgery, RYGB/VSG) | 10 | |
| Overall Study | STARTED | Baseline Pre-hypocaloric Diet (Medical Weight Loss) | 0 | |
| Overall Study | COMPLETED | Baseline (Pre-surgery, RYGB/VSG) | 10 | |
| Overall Study | COMPLETED | Baseline Pre-hypocaloric Diet (Medical Weight Loss) | 0 | |
| Overall Study | NOT COMPLETED | Baseline (Pre-surgery, RYGB/VSG) | 0 | |
| Overall Study | NOT COMPLETED | Baseline Pre-hypocaloric Diet (Medical Weight Loss) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baseline (Pre-surgery, RYGB/VSG) | 0 | 10 |
| Total, all-cause mortality | Baseline Pre-hypocaloric Diet (Medical Weight Loss) | 0 | 0 |
| Total, other adverse events | Baseline (Pre-surgery, RYGB/VSG) | 0 | 10 |
| Total, other adverse events | Baseline Pre-hypocaloric Diet (Medical Weight Loss) | 0 | 0 |
| Total, serious adverse events | Baseline (Pre-surgery, RYGB/VSG) | 0 | 10 |
| Total, serious adverse events | Baseline Pre-hypocaloric Diet (Medical Weight Loss) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03808740
GET https://conductscience.org/api/trials/v1/NCT03808740/registered