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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00495599 |
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.
Condition | Intervention | Phase |
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Obesity |
Procedure: Cytokines assessed from fat tissue |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Adipose Secretory Function in Patients Before & After Laparoscopic Surgery |
Estimated Enrollment: | 120 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2009 |
Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Alfonso Torquati, M.D. | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Alfonso Torquati MD ) |
Study ID Numbers: | 051215 |
Study First Received: | July 2, 2007 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00495599 |
Health Authority: | United States: Institutional Review Board |
Obese Adipose Tissue Visfatin Gastric Bypass Surgery |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |