Status:
COMPLETED
Autonomic Nervous System Function Following Bariatric Surgery
Lead Sponsor:
Christiana Care Health Services
Collaborating Sponsors:
American Society for Metabolic and Bariatric Surgery
Conditions:
Bariatric Surgery
Eligibility:
All Genders
18-60 years
Brief Summary
In the proposed study, the investigators will explore three specific aims. First, the investigators will examine cross-sectionally the association of obesity on sympathetic, parasympathetic, and sympa...
Eligibility Criteria
Inclusion
- Individuals aged 18 - 60 years old.
- Individuals with a BMI \> 35 kg/m2.
- Patients that have enrolled in a program to undergo weight loss by Roux-en-Y gastric bypass and having passed the pre-operative clearance program.
- Individuals with diabetes who are currently being treated with diet, exercise, and/or oral medications will be included.
Exclusion
- Patients that have had previous gastric surgery, including but not limited to pancreobiliary diversion, vertical banded gastroplasty, and jejunoileostomy.
- Individuals with known coronary artery disease (e.g., post-MI), atrial fibrillation,frequent atrial arrhythmias, frequent ventricular arrhythmias, a pacemaker, or myocardial ischemia.
- Individuals taking the following medications that may affect the autonomic nervous system: anti- tuberculosis drugs, nitrofurantoin, metronidazole, chloramphenicol,perhexiline maleate, amiodarone, clofibrate, tricyclic antidepressants, phenytoin,methotrexate, barbiturates, neuroleptic drugs, antiparkinsonism drugs, fluoxetine, and nitrated drugs.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00948545
Start Date
July 1 2009
End Date
April 1 2012
Last Update
November 7 2012
Active Locations (1)
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1
Christiana Care Health Services
Newark, Delaware, United States, 19713