Trial Outcomes & Findings for Orthostatic Intolerance After Bariatric Surgery (NCT NCT03808740)
NCT ID: NCT03808740
Last Updated: 2024-09-27
Results Overview
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.
TERMINATED
PHASE1
10 participants
0- 3 months
2024-09-27
Participant Flow
A total of 10 morbid obese patients, scheduled for bariatric surgery, were enrolled in this study. 10 patients completed all 4 visits, which include a pre-surgical visit, a visit after 10% weight loss, and a visit after 3-months post-surgery. The demographic characteristics of these patients are shown in the table below. We could not enroll any patients, in Medical Weight loss category
Participant milestones
| Measure |
Baseline (Pre-surgery, RYGB/VSG)
Participants underwent Bariatic surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) for weight loss .
|
Baseline Pre-hypocaloric Diet (Medical Weight Loss)
Participants who underwent standard medical weight loss from the Vanderbilt Center for Weight Loss (VWL)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
0
|
|
Overall Study
COMPLETED
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Baseline Characteristics Before Participants Underwent Bariatric Surgery for Weight Loss
n=10 Participants
Participants underwent Bariatic surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) for weight loss .
|
Baseline of Participants Before They Underwent Non Surgical (Medical) Weight Loss Program
Participants who underwent standard medical weight loss from the Vanderbilt Center for Weight Loss (VWL)
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
42 years
STANDARD_DEVIATION 9.3 • n=10 Participants
|
—
|
42 years
STANDARD_DEVIATION 9.3 • n=10 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
9 Participants
n=10 Participants
|
0 Participants
|
9 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
1 Participants
n=10 Participants
|
0 Participants
|
1 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height
|
166 cm
STANDARD_DEVIATION 8.6 • n=10 Participants
|
—
|
166 cm
STANDARD_DEVIATION 8.6 • n=10 Participants
|
|
Fat Mass
|
73 Kg
STANDARD_DEVIATION 12.18 • n=10 Participants
|
—
|
73 Kg
STANDARD_DEVIATION 12.18 • n=10 Participants
|
|
BMI (Body Mass Index)
|
51 kg/m2
STANDARD_DEVIATION 8.27 • n=10 Participants
|
—
|
51 kg/m2
STANDARD_DEVIATION 8.27 • n=10 Participants
|
|
Systolic Blood Pressure
|
128 mm of Hg
STANDARD_DEVIATION 3.69 • n=10 Participants
|
—
|
128 mm of Hg
STANDARD_DEVIATION 3.69 • n=10 Participants
|
|
Diastolic Blood Pressure
|
85 mm of Hg
STANDARD_DEVIATION 4.69 • n=10 Participants
|
—
|
85 mm of Hg
STANDARD_DEVIATION 4.69 • n=10 Participants
|
|
Heart rate
|
93 beats per minute
STANDARD_DEVIATION 7.93 • n=10 Participants
|
—
|
93 beats per minute
STANDARD_DEVIATION 7.93 • n=10 Participants
|
|
Bariatric surgery type
Roux-en-Y Gastric By-Pass procedures
|
7 Participants
n=10 Participants
|
—
|
7 Participants
n=10 Participants
|
|
Bariatric surgery type
Vertical Sleeve Gastric By-Pass
|
3 Participants
n=10 Participants
|
—
|
3 Participants
n=10 Participants
|
|
Total Blood Volume
|
316.1 Litres
STANDARD_DEVIATION 6 • n=10 Participants
|
—
|
316.1 Litres
STANDARD_DEVIATION 6 • n=10 Participants
|
|
Red Blood Cell volume
|
1973 ml
STANDARD_DEVIATION 136.5 • n=10 Participants
|
—
|
1973 ml
STANDARD_DEVIATION 136.5 • n=10 Participants
|
PRIMARY outcome
Timeframe: 0- 3 monthsPopulation: Orthostatic hemodynamics (SBP, DBP, HR) were analyzed as the area under the curve (AUC) after baseline-correction during HUT
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.
Outcome measures
| Measure |
Pre- Bariatric Participants
n=10 Participants
Parameters taken before the subject underwent any of the Bariatric surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analysed for Orthostatic tolerance. .
|
Participants After 10% of Weight Loss
n=10 Participants
Participants who underwent Bariatic surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analyzed for Orthostatic tolerance after 10% of weight loss in morbidly obese patients
|
Participants After 3 Months of the Surgery
n=10 Participants
Participants who underwent Bariatic surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analyzed for Orthostatic tolerance after 3 months in morbidly obese patients
|
|---|---|---|---|
|
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
Systolic Blood pressure: analyze as Area under the curve (AUC) after baseline-correction during HUT.
|
113 mmHg*hr
Standard Deviation 72.41
|
56.02 mmHg*hr
Standard Deviation 30.68
|
39.4 mmHg*hr
Standard Deviation 28.53
|
|
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
Diastolic Blood pressure:analyze as Area under the curve (AUC) after baseline-correction during HUT
|
303.7 mmHg*hr
Standard Deviation 93.74
|
60.98 mmHg*hr
Standard Deviation 29.54
|
39.44 mmHg*hr
Standard Deviation 28.53
|
PRIMARY outcome
Timeframe: 0- 3 monthsPopulation: Orthostatic hemodynamics (Cardiac Output ) were analyzed as the area under the curve (AUC) after baseline-correction during HUT
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.
Outcome measures
| Measure |
Pre- Bariatric Participants
n=10 Participants
Parameters taken before the subject underwent any of the Bariatric surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analysed for Orthostatic tolerance. .
|
Participants After 10% of Weight Loss
n=10 Participants
Participants who underwent Bariatic surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analyzed for Orthostatic tolerance after 10% of weight loss in morbidly obese patients
|
Participants After 3 Months of the Surgery
n=10 Participants
Participants who underwent Bariatic surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analyzed for Orthostatic tolerance after 3 months in morbidly obese patients
|
|---|---|---|---|
|
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
|
9.124 L/min
Standard Deviation 8.066
|
3.562 L/min
Standard Deviation 2.522
|
4.916 L/min
Standard Deviation 3.652
|
PRIMARY outcome
Timeframe: 0- 3 monthsPopulation: Orthostatic hemodynamics (Stroke volume) were analyzed as the area under the curve (AUC) after baseline-correction during HUT
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.
Outcome measures
| Measure |
Pre- Bariatric Participants
n=10 Participants
Parameters taken before the subject underwent any of the Bariatric surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analysed for Orthostatic tolerance. .
|
Participants After 10% of Weight Loss
n=10 Participants
Participants who underwent Bariatic surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analyzed for Orthostatic tolerance after 10% of weight loss in morbidly obese patients
|
Participants After 3 Months of the Surgery
n=10 Participants
Participants who underwent Bariatic surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analyzed for Orthostatic tolerance after 3 months in morbidly obese patients
|
|---|---|---|---|
|
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
|
116.2 mL
Standard Deviation 56.5
|
148 mL
Standard Deviation 78.61
|
105.6 mL
Standard Deviation 60.04
|
PRIMARY outcome
Timeframe: 0- 3 monthsPopulation: Orthostatic hemodynamics (SBP, DBP, HR) were analyzed as the area under the curve (AUC) after baseline-correction during HUT
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
Outcome measures
| Measure |
Pre- Bariatric Participants
n=10 Participants
Parameters taken before the subject underwent any of the Bariatric surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analysed for Orthostatic tolerance. .
|
Participants After 10% of Weight Loss
n=10 Participants
Participants who underwent Bariatic surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analyzed for Orthostatic tolerance after 10% of weight loss in morbidly obese patients
|
Participants After 3 Months of the Surgery
n=10 Participants
Participants who underwent Bariatic surgery Roux-en-Y gastric bypass (RYGB) / Vertical sleeve gastrectomy (VSG) were analyzed for Orthostatic tolerance after 3 months in morbidly obese patients
|
|---|---|---|---|
|
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
|
9.162 mmHg*L/min
Standard Deviation 5.995
|
7.239 mmHg*L/min
Standard Deviation 6.245
|
9.167 mmHg*L/min
Standard Deviation 4.458
|
Adverse Events
Baseline (Pre-surgery, RYGB/VSG)
Baseline Pre-hypocaloric Diet (Medical Weight Loss)
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