Omentectomy for the Treatment of Diabetes Mellitus Type 2
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ClinicalTrials.gov Identifier: NCT00270439 |
Recruitment Status :
Completed
First Posted : December 26, 2005
Last Update Posted : September 14, 2009
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Tracking Information | ||||
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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 |
Insulin sensitivity as measured by the minimal model and HOMA score [ Time Frame: one year post procedure ] | |||
Original Primary Outcome Measures ICMJE |
Insulin sensitivity as measured by the minimal model | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | 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):
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 ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: removal of omentum
patients with type 2 diabetes had their omentum removed
Other Name: laparoscopic omentum removal
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Study Arms ICMJE | Experimental: single arm
Removed omentum of patients with type 2 diabetes
Intervention: Procedure: removal of omentum
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
10 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2007 | |||
Actual Primary Completion Date | January 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | 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 ICMJE | Not Provided | |||
Responsible Party | Dr. William Richards, Vanderbilt University Medical Center | |||
Study Sponsor ICMJE | Vanderbilt University | |||
Collaborators ICMJE | United States Surgical Corporation | |||
Investigators ICMJE |
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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 |