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

Sponsor:	Vanderbilt University
Collaborator:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):	Naji Abumrad, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00212160

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 weight 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: omentectomy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	The Role of the Omentum in the Treatment of Morbid Obesity

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

change in insulin sensitivity [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weight loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment:	66
Study Start Date:	January 2005
Estimated Study Completion Date:	April 2013
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RYGB with omentectomy Subjects undergoing RYGB will be randomized to also have the greater omentum removed at the time of surgery.	Procedure: omentectomy RYGB with omentectomy
No Intervention: RYGB without omentectomy Subjects undergoing RYGB will be randomized to NOT have the greater omentum removed at the time of surgery.
No Intervention: Normal body weight Healthy normal weight subjects studied via hyperinsulinemic-euglycemic clamp to obtain reference values for insulin sensitivity and other metabolic parameters.
No Intervention: Tissue samples Tissue samples (omental fat, subcutaneous fat, muscle,and blood)are obtained from subjects of varying weights during abdominal surgery in order to compare various parameters, including inflammation, oxidative stress, and gene expression, among tissues across weight classes.

Detailed Description:

The purpose of this research is to tease out the mechanisms related to changes in insulin sensitivity, metabolism, hormones, and body composition 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.

Data are derived from tissue and blood samples obtained operatively (from individuals having bariatric surgery and other abdominal operations), as well as during hyperinsulinemic-euglycemic clamps, from indirect calorimetry, DEXA, Health-related Quality of Life surveys, and 24-hour urine samples. There were 66 participants randomized to omentectomy/no omentectomy. A post hoc data power analysis determined that this number of subjects is sufficient for data analysis.

Eligibility

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

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

Locations

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

Sponsors and Collaborators

Vanderbilt University

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

Investigators

Principal Investigator:

Naji N Abumrad, MD

Vanderbilt University

More Information

Publications:

Fabbrini E, Tamboli RA, Magkos F, Marks-Shulman PA, Eckhauser AW, Richards WO, Klein S, Abumrad NN. Surgical removal of omental fat does not improve insulin sensitivity and cardiovascular risk factors in obese adults. Gastroenterology. 2010 Aug;139(2):448-55. Epub 2010 May 7.

Hajri T, Tao H, Wattacheril J, Marks-Shulman P, Abumrad NN. Regulation of adiponectin production by insulin: interactions with tumor necrosis factor-? and interleukin-6. Am J Physiol Endocrinol Metab. 2011 Feb;300(2):E350-60. Epub 2010 Nov 9.

Saliba J, Kasim NR, Tamboli RA, Isbell JM, Marks P, Feurer ID, Ikizler A, Abumrad NN. Roux-en-Y gastric bypass reverses renal glomerular but not tubular abnormalities in excessively obese diabetics. Surgery. 2010 Feb;147(2):282-7. Epub 2009 Dec 11.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tamboli RA, Hajri T, Jiang A, Marks-Shulman PA, Williams DB, Clements RH, Melvin W, Bowen BP, Shyr Y, Abumrad NN, Flynn CR. Reduction in inflammatory gene expression in skeletal muscle from Roux-en-Y gastric bypass patients randomized to omentectomy. PLoS One. 2011;6(12):e28577. Epub 2011 Dec 16.

Dunn JP, Abumrad NN, Breitman I, Marks-Shulman PA, Flynn CR, Jabbour K, Feurer ID, Tamboli RA. Hepatic and peripheral insulin sensitivity and diabetes remission at 1 month after Roux-en-Y gastric bypass surgery in patients randomized to omentectomy. Diabetes Care. 2012 Jan;35(1):137-42. Epub 2011 Oct 31.

Responsible Party:	Naji Abumrad, Chairman, Department of Surgery, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00212160 History of Changes
Obsolete Identifiers:	NCT00247598
Other Study ID Numbers:	IRB #040572, R01DK070860, 3 RO1 DK 070860-01S1
Study First Received:	September 13, 2005
Last Updated:	November 15, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012