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Autonomic Nervous System Function Following Bariatric Surgery

This study has been completed.
Sponsor:
Collaborator:
American Society for Metabolic and Bariatric Surgery
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00948545
First received: July 28, 2009
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Bariatric Surgery
 Other: Observational study - there is no intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Autonomic Nervous System Function and Novel Determinants of Glucose Homeostasis Following Bariatric Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum, plasma, urine


Enrollment: 37
Study Start Date: July 2009
Study Completion Date: April 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment
Observing individuals pre and post bariatric surgery
 Other: Observational study - there is no intervention
Observational study - there is no intervention

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals having bariatric surgery

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948545

Locations
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
Sponsors and Collaborators
Christiana Care Health Services
American Society for Metabolic and Bariatric Surgery
Investigators
Principal Investigator: M James Lenhard, MD Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00948545     History of Changes
Other Study ID Numbers: 29092
Study First Received: July 28, 2009
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Autonomic nervous system
Bariatric surgery
Observational study for individuals having bariatric surgery

ClinicalTrials.gov processed this record on May 21, 2013