Clinical trial NCT00948545: Autonomic Nervous System Function Following Bariatric Surgery
Official title: Autonomic Nervous System Function and Novel Determinants of Glucose Homeostasis Following Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Keywords: Autonomic nervous system
Bariatric surgery
Observational study for individuals having bariatric surgery
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: American Society for Metabolic and Bariatric Surgery
First posted: 2009-07-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals having bariatric surgery

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 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.


Eligibility criteria: Inclusion Criteria:

1. Individuals aged 18 - 60 years old.
2. Individuals with a BMI \> 35 kg/m2.
3. 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.
4. Individuals with diabetes who are currently being treated with diet, exercise, and/or oral medications will be included.

Exclusion Criteria:

1. Patients that have had previous gastric surgery, including but not limited to pancreobiliary diversion, vertical banded gastroplasty, and jejunoileostomy.
2. Individuals with known coronary artery disease (e.g., post-MI), atrial fibrillation,frequent atrial arrhythmias, frequent ventricular arrhythmias, a pacemaker, or myocardial ischemia.
3. 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: M James Lenhard, MD
role: PRINCIPAL_INVESTIGATOR
References: