Autonomic Nervous System Function Following Bariatric Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00948545

Enrollment

Registered

2009-07-29

Start date

2009-07-31

Completion date

2012-04-30

Last updated

2012-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery

Keywords

Autonomic nervous system, Bariatric surgery, Observational study for 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.

Interventions

OTHERObservational study - there is no intervention

Observational study - there is no intervention

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	2 years

Secondary

Measure	Time frame
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.	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026