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Omentectomy for the Treatment of Diabetes Mellitus Type 2

Primary Purpose

Diabetes Mellitus Type 2, Dyslipidemia, Hypercholesterolemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
removal of omentum
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Obesity, Omentectomy, Diabetes Mellitus Type 2, Laparoscopic, Dyslipidemia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

Removed omentum of patients with type 2 diabetes

Outcomes

Primary Outcome Measures

Insulin sensitivity as measured by the minimal model and HOMA score

Secondary Outcome Measures

Improvement in dyslipidemia
Decreased use of oral hypoglycemics

Full Information

First Posted
December 22, 2005
Last Updated
September 10, 2009
Sponsor
Vanderbilt University
Collaborators
United States Surgical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00270439
Brief Title
Omentectomy for the Treatment of Diabetes Mellitus Type 2
Official Title
Omentectomy for Treatment of Diabetes Mellitus Type 2
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vanderbilt University
Collaborators
United States Surgical Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2, Dyslipidemia, Hypercholesterolemia, Obesity
Keywords
Obesity, Omentectomy, Diabetes Mellitus Type 2, Laparoscopic, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Arm Description
Removed omentum of patients with type 2 diabetes
Intervention Type
Procedure
Intervention Name(s)
removal of omentum
Other Intervention Name(s)
laparoscopic omentum removal
Intervention Description
patients with type 2 diabetes had their omentum removed
Primary Outcome Measure Information:
Title
Insulin sensitivity as measured by the minimal model and HOMA score
Time Frame
one year post procedure
Secondary Outcome Measure Information:
Title
Improvement in dyslipidemia
Time Frame
One year post procedure
Title
Decreased use of oral hypoglycemics
Time Frame
One year post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William O Richards, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11850750
Citation
Thorne A, Lonnqvist 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. doi: 10.1038/sj.ijo.0801871.
Results Reference
background
PubMed Identifier
16269382
Citation
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. doi: 10.1016/j.gassur.2005.07.016.
Results Reference
background
Citation
Hansen, E., et al., Omentectomy Improves Insulin Sensitivity in Skeletal Muscle in vivo. 2005, Abstract Society of University Surgeons.
Results Reference
background
PubMed Identifier
3884329
Citation
Bergman RN, Finegood DT, Ader M. Assessment of insulin sensitivity in vivo. Endocr Rev. 1985 Winter;6(1):45-86. doi: 10.1210/edrv-6-1-45. No abstract available.
Results Reference
background
PubMed Identifier
9753305
Citation
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. doi: 10.2337/diabetes.47.10.1643.
Results Reference
background
PubMed Identifier
3899825
Citation
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. doi: 10.1007/BF00280883.
Results Reference
background
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
derived

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Omentectomy for the Treatment of Diabetes Mellitus Type 2

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