Status:
TERMINATED
Orthostatic Intolerance After Bariatric Surgery
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Orthostatic Intolerance
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 cardiovascul...
Detailed Description
Considering that SNS vasoconstrictor activity depends on synaptic norepinephrine concentrations, investigators propose a proof-of-concept study to test the hypothesis that the norepinephrine transport...
Eligibility Criteria
Inclusion
- Obese subjects that will undergo bariatric surgery or medical weight loss.
- Age 18-60 years
- BMI \>35 kg/m2
- Weight \< 400 lbs
Exclusion
- Diabetes type 1
- Use of an alpha blockers, clonidine, beta-blockers.
- Pregnancy or breast-feeding. Women of childbearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control.
- The use of any strong CYP2D6 inhibitor (e.g., fluoxetine, paroxetine, quinidine, tipranavir).
- Use of selective NET inhibitors.
- Use of monoamine oxidase inhibitors.
- Cardiovascular disease such as myocardial infarction within six months prior to the study, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
- History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
- Hematocrit \< 34%
- Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
- Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study
- Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, unlikelihood of completing the study, and investigator discretion
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03808740
Start Date
July 1 2018
End Date
May 31 2021
Last Update
September 27 2024
Active Locations (1)
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1
Cyndya Shibao
Nashville, Tennessee, United States, 37027