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Completed

NCT Number: NCT00948545

Autonomic Nervous System Function Following Bariatric Surgery

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 sympathetic/ parasympathetic nerve fiber balance. In addition, the investigators will determine the relationship of the ANS and osteocalcin. Osteocalcin will be measured before and after a mixed meal tolerance test.

In the second specific aim, the investigators will prospectively follow-up these individuals (n=30) following bariatric surgery. The effect of weight loss on measures of the ANS and osteocalcin will be examined 6 months following surgery with participants serving as their own control, pre- and post-surgical intervention.

Thirdly, the investigators will address whether the effect of weight loss on the ANS and osteocalcin differ between those who had a history of diabetes at baseline versus those with no history of diabetes.

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Key information

Conditions

Bariatric Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Observational study - there is no intervention

Other

Observational study - there is no intervention

Primary outcomes

  1. To determine the association of obesity on sympathetic, parasympathetic, and sympathetic/parasympathetic nerve fiber balance and to determine the relationship of the ANS and osteocalcin.

    Time frame: 2 years

Secondary outcomes

  1. To determine the effect of weight loss on measures of the ANS and determinants of insulin sensitivity (e.g., osteocalcin) 6 months following surgery with participants serving as their own control, pre- and post-surgical intervention.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • American Society for Metabolic and Bariatric Surgery

Registry information

Official study title

Autonomic Nervous System Function and Novel Determinants of Glucose Homeostasis Following Bariatric Surgery

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jul 29, 2009
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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