Adipose Secretory Function in Patients Before & After Laparoscopic Surgery - Full Text View

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 III

MedlinePlus related topics:

Obesity

U.S. FDA Resources

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

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:

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

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

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

Keywords provided by Vanderbilt University:

Obese

Adipose Tissue

Visfatin

Gastric Bypass Surgery

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00495599