Adipose Secretory Function in Patients Before & After Laparoscopic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00495599
First received: July 2, 2007
Last updated: February 7, 2008
Last verified: February 2008
  Purpose

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
Obesity
Procedure: Cytokines assessed from fat tissue
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Adipose Secretory Function in Patients Before & After Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

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 ]

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)
Intervention Details:
    Procedure: Cytokines assessed from fat tissue
    Cytokines assessed from fat tissue
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with a BMI < 35undergoing laparoscopic surgery;
  • Patients undergoing bariatric surgery with a BMI >35kg/m2; and
  • Those patients who have had gastric by-pass that require additional surgical procedures are eligible for this research protocol.

Exclusion Criteria:

  • Unwilling to consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495599

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Alfonso Torquati, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Alfonso Torquati MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00495599     History of Changes
Other Study ID Numbers: 051215
Study First Received: July 2, 2007
Last Updated: February 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Obese
Adipose Tissue
Visfatin
Gastric Bypass Surgery

ClinicalTrials.gov processed this record on September 22, 2014