Status:
COMPLETED
Omentectomy for the Treatment of Diabetes Mellitus Type 2
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
United States Surgical Corporation
Conditions:
Diabetes Mellitus Type 2
Dyslipidemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
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 mea...
Eligibility Criteria
Inclusion
- age 18-55
- BMI 30-50
- Dyslipidemia
- Non-insulin dependent Type 2 diabetes Mellitus on oral hypoglycemics only
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00270439
Start Date
January 1 2006
End Date
March 1 2007
Last Update
September 14 2009
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232