Omentectomy for the Treatment of Diabetes Mellitus Type 2

Tracking Information
First Submitted Date ICMJE	December 22, 2005
First Posted Date ICMJE	December 26, 2005
Last Update Posted Date	September 14, 2009
Study Start Date ICMJE	January 2006
Actual Primary Completion Date	January 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 12, 2008)	Insulin sensitivity as measured by the minimal model and HOMA score [ Time Frame: one year post procedure ]
Original Primary Outcome Measures ICMJE; (submitted: December 22, 2005)	Insulin sensitivity as measured by the minimal model
Change History	Complete list of historical versions of study NCT00270439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 12, 2008)	Improvement in dyslipidemia [ Time Frame: One year post procedure ]; Decreased use of oral hypoglycemics [ Time Frame: One year post procedure ]
Original Secondary Outcome Measures ICMJE; (submitted: December 22, 2005)	Improvement in dyslipidemia; Decreased use of oral hypoglycemics
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Omentectomy for the Treatment of Diabetes Mellitus Type 2
Official Title ICMJE	Omentectomy for Treatment of Diabetes Mellitus Type 2
Brief Summary	The purpose of this study is to determine whether laparoscopic removal of the omentum (thin layer of fat inside the abdomen) will significantly improve insulin resistance in patients with non-insulin dependent type 2 diabetes mellitus.
Detailed Description	Clinical studies have shown that central obesity is one of the strongest associations with Type II diabetes. Measurement of waist circumference at Vanderbilt was one of the most effective clinical measures of presence of type II diabetes and response to gastric bypass in a recent study. This central obesity points to the omentum as one of the major culprits for development and perpetuation of type II diabetes in humans. [1] Animal studies at Vanderbilt have shown in normal size dogs that surgical removal of the visceral fat (Omentectomy): Decreases basal hepatic glucose production by nearly 40%; Results in decreased FFA delivery to the liver; Increases glucose utilization by peripheral insulin dependent tissues, predominantly skeletal muscle. [2] The animal studies were started to pursue the positive results seen by Swedish investigators who randomized 50 patients to either gastric banding or to gastric banding with omentectomy. At 2 years both groups had statistically similar weight loss but the patients in the omentectomy group had 2 to 3 times the improvements in oral glucose tolerance, insulin sensitivity and fasting plasma glucose as compared to control subjects. [3] They concluded that omentectomy, when combined with gastric banding in morbidly obese patients had a significant positive effects on the glucose and insulin metabolism. Why does the removal of visceral fat (a very small percentage of the animal's weight) cause a 40% increase in peripheral glucose metabolism? The omentum is known to be a repository for macrophages and the increase in macrophage numbers is proportional to the increase in adiposity in humans. Both macrophages and adipocytes produce adipokines and cytokines that are known to influence glucose and insulin metabolism. The omentum is also known to be the major contributor of Free Fatty Acids into the portal circulation which adversely affects the hepatic insulin resistance. Resection of the visceral fat which holds more numbers of the macrophages which in turn release the cytokines that preferentially disturb glucose metabolism should in theory then result in a marked improvement in glucose and fat metabolism. Hypothesis Removal of visceral fat (omentectomy) will significantly improve type II Diabetes and dyslipidemia. Specific Aim 1: Determine the improvement in glucose metabolism in patients with type II diabetes using Minimal model study at baseline and at 3 months post surgery Specific Aim 2: Determine the improvement in control of type II diabetes by measuring HgbA1c levels and the amount of oral medications taken to control their diabetes 3, 6 and 12 months post surgery. Specific aim 3: Determine the improvement in lipids by measuring fasting serum total cholesterol, HDL, LDL and Triglycerides at 0, 3, 6, and 12 months post surgery. Specific Aim 4: Determine the effect of omentectomy on markers of inflammation (C- reactive protein, interleukin 6) at 3, 6, and 12 months post op. These labs will be drawn but not assayed until we see the effects on insulin resistance.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Diabetes Mellitus Type 2; Dyslipidemia; Hypercholesterolemia; Obesity
Intervention ICMJE	Procedure: removal of omentum; patients with type 2 diabetes had their omentum removed; Other Name: laparoscopic omentum removal
Study Arms	Experimental: single arm; Removed omentum of patients with type 2 diabetes; Intervention: Procedure: removal of omentum
Publications *	Thörne A, Lönnqvist F, Apelman J, Hellers G, Arner P. A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding. Int J Obes Relat Metab Disord. 2002 Feb;26(2):193-9.; Torquati A, Lutfi R, Abumrad N, Richards WO. Is Roux-en-Y gastric bypass surgery the most effective treatment for type 2 diabetes mellitus in morbidly obese patients? J Gastrointest Surg. 2005 Nov;9(8):1112-6; discussion 1117-8.; Hansen, E., et al., Omentectomy Improves Insulin Sensitivity in Skeletal Muscle in vivo. 2005, Abstract Society of University Surgeons.; Bergman RN, Finegood DT, Ader M. Assessment of insulin sensitivity in vivo. Endocr Rev. 1985 Winter;6(1):45-86. Review.; Bonora E, Kiechl S, Willeit J, Oberhollenzer F, Egger G, Targher G, Alberiche M, Bonadonna RC, Muggeo M. Prevalence of insulin resistance in metabolic disorders: the Bruneck Study. Diabetes. 1998 Oct;47(10):1643-9.; Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 22, 2005)	10
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2007
Actual Primary Completion Date	January 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: age 18-55; BMI 30-50; Dyslipidemia; Non-insulin dependent Type 2 diabetes Mellitus on oral hypoglycemics only Exclusion Criteria: Medicare patients; significant hepatic enzyme elevations (more than 50% of upper limits of normal); serum creatinine >1.5 mg/dl; history of ketoacidosis or current metabolic acidosis; current use of oral anticoagulants; positive pregnancy test (β-human chorionic gonadotrophin) for females; intercurrent infections; taking drugs that are known to affect carbohydrate or lipid metabolism (e.g. steroids, high dose Niacin, β-adrenergic receptor agonists, but does not include anti-diabetic drugs)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00270439
Other Study ID Numbers ICMJE	050967
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr. William Richards, Vanderbilt University Medical Center
Study Sponsor ICMJE	Vanderbilt University
Collaborators ICMJE	United States Surgical Corporation
Investigators ICMJE	Principal Investigator: William O Richards, MD Vanderbilt University Medical Center
PRS Account	Vanderbilt University
Verification Date	September 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP