Autonomic Nervous System Function Following Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT00948545|
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : November 7, 2012
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 or disease||Intervention/treatment|
|Bariatric Surgery||Other: Observational study - there is no intervention|
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Autonomic Nervous System Function and Novel Determinants of Glucose Homeostasis Following Bariatric Surgery|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||April 2012|
Observing individuals pre and post bariatric surgery
Other: Observational study - there is no intervention
Observational study - there is no intervention
- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948545
|United States, Delaware|
|Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|Principal Investigator:||M James Lenhard, MD||Christiana Care Health Services|