![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | December 22, 2005 | ||||
Last Updated Date | February 4, 2009 | ||||
Start Date † | January 2006 | ||||
Current Primary Outcome Measures † |
Insulin sensitivity as measured by the minimal model and HOMA score [ Time Frame: one year post procedure ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00270439 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
|
||||
Original Secondary Outcome Measures † |
|
||||
Descriptive Information | |||||
Brief Title † | Omentectomy for the Treatment of Diabetes Mellitus Type 2 | ||||
Official Title † | 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. |
||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † |
|
||||
Intervention † | Procedure: removal of omentum | ||||
Study Arms / Comparison Groups | Experimental: Removed omentum of patients with type 2 diabetes | ||||
Publications * |
|
||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 10 | ||||
Completion Date | March 2007 | ||||
Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00270439 | ||||
Responsible Party | Dr. William Richards, Vanderbilt University Medical Center | ||||
Secondary IDs †† | |||||
Study Sponsor † | Vanderbilt University | ||||
Collaborators †† | United States Surgical | ||||
Investigators † |
|
||||
Information Provided By | Vanderbilt University | ||||
Verification Date | February 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |