search
Back to results

The Role of the Omentum in the Treatment of Morbid Obesity

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
omentectomy
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

No Intervention

No Intervention

Arm Label

RYGB with omentectomy

RYGB without omentectomy

Normal body weight

Tissue samples

Arm Description

Subjects undergoing RYGB will be randomized to also have the greater omentum removed at the time of surgery.

Subjects undergoing RYGB will be randomized to NOT have the greater omentum removed at the time of surgery.

Healthy normal weight subjects studied via hyperinsulinemic-euglycemic clamp to obtain reference values for insulin sensitivity and other metabolic parameters.

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.

Outcomes

Primary Outcome Measures

change in insulin sensitivity

Secondary Outcome Measures

Weight loss

Full Information

First Posted
September 13, 2005
Last Updated
January 30, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT00212160
Brief Title
The Role of the Omentum in the Treatment of Morbid Obesity
Official Title
The Role of the Omentum in the Treatment of Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (Actual)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RYGB with omentectomy
Arm Type
Experimental
Arm Description
Subjects undergoing RYGB will be randomized to also have the greater omentum removed at the time of surgery.
Arm Title
RYGB without omentectomy
Arm Type
No Intervention
Arm Description
Subjects undergoing RYGB will be randomized to NOT have the greater omentum removed at the time of surgery.
Arm Title
Normal body weight
Arm Type
No Intervention
Arm Description
Healthy normal weight subjects studied via hyperinsulinemic-euglycemic clamp to obtain reference values for insulin sensitivity and other metabolic parameters.
Arm Title
Tissue samples
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
omentectomy
Intervention Description
RYGB with omentectomy
Primary Outcome Measure Information:
Title
change in insulin sensitivity
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Weight loss
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naji N Abumrad, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20457158
Citation
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. doi: 10.1053/j.gastro.2010.04.056. Epub 2010 May 7.
Results Reference
result
PubMed Identifier
20004430
Citation
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. doi: 10.1016/j.surg.2009.09.017. Epub 2009 Dec 11.
Results Reference
result
PubMed Identifier
21062957
Citation
Hajri T, Tao H, Wattacheril J, Marks-Shulman P, Abumrad NN. Regulation of adiponectin production by insulin: interactions with tumor necrosis factor-alpha and interleukin-6. Am J Physiol Endocrinol Metab. 2011 Feb;300(2):E350-60. doi: 10.1152/ajpendo.00307.2010. Epub 2010 Nov 9.
Results Reference
result
PubMed Identifier
26196952
Citation
Albaugh VL, Flynn CR, Cai S, Xiao Y, Tamboli RA, Abumrad NN. Early Increases in Bile Acids Post Roux-en-Y Gastric Bypass Are Driven by Insulin-Sensitizing, Secondary Bile Acids. J Clin Endocrinol Metab. 2015 Sep;100(9):E1225-33. doi: 10.1210/jc.2015-2467. Epub 2015 Jul 21.
Results Reference
result
PubMed Identifier
25236175
Citation
Knuth ND, Johannsen DL, Tamboli RA, Marks-Shulman PA, Huizenga R, Chen KY, Abumrad NN, Ravussin E, Hall KD. Metabolic adaptation following massive weight loss is related to the degree of energy imbalance and changes in circulating leptin. Obesity (Silver Spring). 2014 Dec;22(12):2563-9. doi: 10.1002/oby.20900. Epub 2014 Sep 19. Erratum In: Obesity (Silver Spring). 2016 Oct;24(10):2248.
Results Reference
result
PubMed Identifier
24777992
Citation
Tamboli RA, Breitman I, Marks-Shulman PA, Jabbour K, Melvin W, Williams B, Clements RH, Feurer ID, Abumrad NN. Early weight regain after gastric bypass does not affect insulin sensitivity but is associated with elevated ghrelin. Obesity (Silver Spring). 2014 Jul;22(7):1617-22. doi: 10.1002/oby.20776. Epub 2014 Apr 29.
Results Reference
result
PubMed Identifier
22194858
Citation
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. doi: 10.1371/journal.pone.0028577. Epub 2011 Dec 16.
Results Reference
result
PubMed Identifier
20414197
Citation
Tamboli RA, Hossain HA, Marks PA, Eckhauser AW, Rathmacher JA, Phillips SE, Buchowski MS, Chen KY, Abumrad NN. Body composition and energy metabolism following Roux-en-Y gastric bypass surgery. Obesity (Silver Spring). 2010 Sep;18(9):1718-24. doi: 10.1038/oby.2010.89. Epub 2010 Apr 22.
Results Reference
result
PubMed Identifier
22040841
Citation
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. doi: 10.2337/dc11-1383. Epub 2011 Oct 31.
Results Reference
derived

Learn more about this trial

The Role of the Omentum in the Treatment of Morbid Obesity

We'll reach out to this number within 24 hrs