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Omentectomy for the Treatment of Diabetes Mellitus Type 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00270439
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : September 14, 2009
United States Surgical Corporation
Information provided by:
Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Dyslipidemia Hypercholesterolemia Obesity Procedure: removal of omentum Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Omentectomy for Treatment of Diabetes Mellitus Type 2
Study Start Date : January 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: single arm
Removed omentum of patients with type 2 diabetes
Procedure: removal of omentum
patients with type 2 diabetes had their omentum removed
Other Name: laparoscopic omentum removal

Primary Outcome Measures :
  1. Insulin sensitivity as measured by the minimal model and HOMA score [ Time Frame: one year post procedure ]

Secondary Outcome Measures :
  1. Improvement in dyslipidemia [ Time Frame: One year post procedure ]
  2. Decreased use of oral hypoglycemics [ Time Frame: One year post procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00270439

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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
United States Surgical Corporation
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Principal Investigator: William O Richards, MD Vanderbilt University Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. William Richards, Vanderbilt University Medical Center Identifier: NCT00270439    
Other Study ID Numbers: 050967
First Posted: December 26, 2005    Key Record Dates
Last Update Posted: September 14, 2009
Last Verified: September 2009
Keywords provided by Vanderbilt University:
Diabetes Mellitus Type 2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders