Adipose Secretory Function in Patients Before & After Laparoscopic Surgery

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT00495599
Collaborator
(none)
107
1
45
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cytokines assessed from fat tissue
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Adipose Secretory Function in Patients Before & After Laparoscopic Surgery
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Outcome Measures

Primary Outcome Measures

  1. The primary endpoint of the study is change in mRNA levels of Visfatin. [Levels of Visfatin will be assayed from fat tissue taken before and after gastric bypass surgery or other laparoscopic surgery.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

Sponsors and Collaborators

  • Vanderbilt University

Investigators

  • Principal Investigator: Alfonso Torquati, M.D., Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00495599
Other Study ID Numbers:
  • 051215
First Posted:
Jul 3, 2007
Last Update Posted:
Nov 21, 2016
Last Verified:
Nov 1, 2016
Keywords provided by Vanderbilt University

Study Results

No Results Posted as of Nov 21, 2016