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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
Sponsor:
Collaborator:
United States Surgical Corporation
Information provided by:
Vanderbilt University

Tracking Information
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
 (submitted: December 12, 2008)
Insulin sensitivity as measured by the minimal model and HOMA score [ Time Frame: one year post procedure ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
Insulin sensitivity as measured by the minimal model
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
  • Improvement in dyslipidemia [ Time Frame: One year post procedure ]
  • Decreased use of oral hypoglycemics [ Time Frame: One year post procedure ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
  • Improvement in dyslipidemia
  • Decreased use of oral hypoglycemics
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):

  • 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.

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
Condition  ICMJE
  • Diabetes Mellitus Type 2
  • Dyslipidemia
  • Hypercholesterolemia
  • Obesity
Intervention  ICMJE Procedure: removal of omentum
patients with type 2 diabetes had their omentum removed
Other Name: laparoscopic omentum removal
Study Arms  ICMJE Experimental: single arm
Removed omentum of patients with type 2 diabetes
Intervention: Procedure: removal of omentum
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2005)
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:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: William O Richards, MD Vanderbilt University Medical Center
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