The Role of the Omentum in the Treatment of Morbid Obesity - Full Text View

Purpose

The purpose of this research is to determine some of the reasons that blood sugar and insulin levels improve after bariatric surgery but before weight loss begins, as well as why people respond differently to weigh loss surgery. It will also examine whether removing the fat around the stomach and large intestine (the omentum) will improve weight loss. Finally, it will see why there are differences between Whites and African Americans who have weight loss surgery.

Condition	Intervention
Obesity	Procedure: RYGB with omentectomy Procedure: omentectomy Procedure: RYGB without omentectomy

MedlinePlus related topics:

Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

Official Title:	The Role of the Omentum in the Treatment of Morbid Obesity

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

change in insulin sensitivity [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	135
Study Start Date:	January 2005
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental RYGB with omentectomy	Procedure: RYGB with omentectomy RYGB with omentectomy Procedure: omentectomy RYGB with omentectomy
2: Active Comparator RYGB without omentectomy	Procedure: RYGB without omentectomy RYGB without omentectomy

Detailed Description:

The purpose of this research is to tease out the mechanisms related to metabolic improvements following bariatric surgery. Because preliminary data indicate differing responses to this surgery, both Caucasian and African American adults, scheduled for RYGB, are being recruited to participate. It is believed that the omentum contributes to hepatic insulin resistance, both because of the increased delivery of NEFAs via the portal vein, and the increased production of cytokines. Because of this, it is postulated that removing the omentum as part of bariatric surgery will speed up the reversal of insulin resistance and diminish racial differences in response to the surgery.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

BMI > 40
BMI > 35 with co-morbidities
normal creatinine/liver labs
insurance approval for RYGB or resources to self-pay
proximity to Nashville, TN

Exclusion Criteria:

use of anticoagulants, steroids, therapeutic niacin
previous bariatric surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212160

Contacts


Contact: Pamela A Marks, MS, RD	615-343-8389	pamela.a.marks@vanderbilt.edu

Locations


United States, Tennessee
	Vanderbilt University Medical Center	Recruiting
	Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators


Principal Investigator:	Naji N Abumrad, MD	Vanderbilt University

More Information

Responsible Party:	Vanderbilt University Medical Center ( Naji Abumrad, MD )
Study ID Numbers:	IRB #040572, 3 RO1 DK 070860-01S1
First Received:	September 13, 2005
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00212160
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

Obesity, Morbid

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00212160