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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Christiana Care Health Services

Newark, Delaware, United States, 19713