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Sponsors and Collaborators: |
Vanderbilt University United States Surgical |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00270439 |
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 | Intervention | Phase |
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Diabetes Mellitus Type 2 Dyslipidemia Hypercholesterolemia Obesity |
Procedure: removal of omentum |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Omentectomy for Treatment of Diabetes Mellitus Type 2 |
Enrollment: | 10 |
Study Start Date: | January 2006 |
Study Completion Date: | March 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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single arm: Experimental
Removed omentum of patients with type 2 diabetes
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Procedure: removal of omentum
patients with type 2 diabetes had their omentum removed
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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):
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | William O Richards, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University Medical Center ( Dr. William Richards ) |
Study ID Numbers: | 050967 |
Study First Received: | December 22, 2005 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00270439 |
Health Authority: | United States: Institutional Review Board |
Obesity Omentectomy Diabetes Mellitus Type 2 Laparoscopic Dyslipidemia |
Obesity Metabolic Diseases Hyperlipidemias Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Signs and Symptoms Diabetes Mellitus, Type 2 |
Nutrition Disorders Overnutrition Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |