Omentectomy for the Treatment of Diabetes Mellitus Type 2

This study has been completed.
Sponsor:
Collaborator:
United States Surgical
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00270439
First received: December 22, 2005
Last updated: September 10, 2009
Last verified: September 2009
  Purpose

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
Diabetes Mellitus Type 2
Dyslipidemia
Hypercholesterolemia
Obesity
Procedure: removal of omentum
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Omentectomy for Treatment of Diabetes Mellitus Type 2

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

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 ]

Secondary Outcome Measures:
  • Improvement in dyslipidemia [ Time Frame: One year post procedure ] [ Designated as safety issue: Yes ]
  • Decreased use of oral hypoglycemics [ Time Frame: One year post procedure ] [ Designated as safety issue: No ]

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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270439

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
United States Surgical
Investigators
Principal Investigator: William O Richards, MD Vanderbilt University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. William Richards, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00270439     History of Changes
Other Study ID Numbers: 050967
Study First Received: December 22, 2005
Last Updated: September 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Obesity
Omentectomy
Diabetes Mellitus Type 2
Laparoscopic
Dyslipidemia

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus
Dyslipidemias
Hypercholesterolemia
Diabetes Mellitus, Type 2
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Hyperlipidemias

ClinicalTrials.gov processed this record on September 16, 2014