The Role of the Omentum in the Treatment of Morbid Obesity

NCT ID: NCT00212160

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2011-10-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

RYGB with omentectomy

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

Group Type: EXPERIMENTAL

omentectomy

Intervention Type: PROCEDURE

RYGB with omentectomy

RYGB without omentectomy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Normal body weight

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

omentectomy

RYGB with omentectomy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Naji Abumrad

Chairman, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naji N Abumrad, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20457158 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20004430 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21062957 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26196952 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25236175 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24777992 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22194858 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20414197 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22040841 (View on PubMed)

Other Identifiers

R01DK070860

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3R01DK070860-01S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB #040572

Identifier Type: -

Identifier Source: org_study_id

NCT00247598

Identifier Type: -

Identifier Source: nct_alias