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Tracking Information | |||||
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First Received Date † | July 2, 2007 | ||||
Last Updated Date | February 7, 2008 | ||||
Start Date † | March 2006 | ||||
Current Primary Outcome Measures † |
The primary endpoint of the study is change in mRNA levels of Visfatin. [ Time Frame: Levels of Visfatin will be assayed from fat tissue taken before and after gastric bypass surgery or other laparoscopic surgery. ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00495599 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Adipose Secretory Function in Patients Before & After Laparoscopic Surgery | ||||
Official Title † | Adipose Secretory Function in Patients Before & After Laparoscopic Surgery | ||||
Brief Summary | The central hypothesis of our study is that metabolic and hemodynamic improvements following gastric bypass surgery are mediated by downregulation of inflammation-related adipokines produced by the intra-abdominal adipose tissue such as Visfatin. |
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Detailed Description | Central obesity represents a major risk for the development of type 2 diabetes and cardiovascular complications. Obesity is often associated with insulin resistance and abnormal production of inflammatory cytokines. Adipose tissue and especially omentum (adipocytes and resident macrophages) release several cytokines. Visfatin corresponds to a protein identified previously as pre-B cell colony-enhancing factor (PBEF), a 52-kilodalton cytokine expressed in lymphocytes. [1] Visfatin exerted insulin-mimetic effects in cultured cells and lowered plasma glucose levels in mice. Mice heterozygous for a targeted mutation in the visfatin gene had modestly higher levels of plasma glucose relative to wild-type littermates. Surprisingly, visfatin binds to and activates the insulin receptor. Adipose tissue protein and mRNA expression of Visfatin (PBEF) has not been investigated in a single study design with regard to the relationship to fat distribution, insulin resistance and other metabolic risk factors, especially in morbidly obese individual undergoing weight loss surgery. Therefore, we propose the following specific aims: Investigate the protein and mRNA expression of Visfatin (PBEF) in the peripheral (subcutaneous) and visceral (omentum) adipose tissues of morbidly obese subjects and their relationships to the changes in body composition, fat distribution, insulin sensitivity and time-dependent reversal of co-morbidities following gastric bypass surgery. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
Condition † | Obesity | ||||
Intervention † | Procedure: Cytokines assessed from fat tissue | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 120 | ||||
Estimated Completion Date | December 2009 | ||||
Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00495599 | ||||
Responsible Party | Alfonso Torquati MD, Vanderbilt University | ||||
Secondary IDs †† | |||||
Study Sponsor † | Vanderbilt University | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Vanderbilt University | ||||
Verification Date | February 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |