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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Autonomic Nervous System Function and Novel Determinants of Glucose Homeostasis Following Bariatric Surgery|
- 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 ]
- 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
|Study Start Date:||July 2009|
|Study Completion Date:||April 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Observing individuals pre and post bariatric surgery
Other: Observational study - there is no intervention
Observational study - there is no intervention
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948545
|United States, Delaware|
|Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|Principal Investigator:||M James Lenhard, MD||Christiana Care Health Services|