Age 18-64 Years Clinical Trial
Official title:
A Pilot Study of Metabolic Effects of Omentectomy in Obese Patients With Type 2 Diabetes Mellitus Treated With Laparoscopic Adjustable Gastric Banding (LAGB)
PROTOCOL SUMMARY
Type of Study: Pilot, randomized and single center trial Test Procedure: Omentectomy Aim 1.
Determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3)
plasma markers of inflammation We hypothesize that removal of omental fat increases insulin
sensitivity and pancreatic sensitivity to glucose, and decreases systemic inflammation.
Aim 2. Identify genes and proteins in adipocytes from obese patients that affect clinical
presentation versus those that are affected by obesity for future study.
We hypothesize that the genetic samples will help us to identify genes and proteins in
adipocytes from obese patients that affect clinical presentation versus those that are
affected by obesity and help us to design future obesity genetic studies.
Total Enrollment Number: 30 patients who are scheduled to undergo bariatric surgery for
weight loss at New York University Medical Center will be invited to participate in this
study. Subjects will be randomly assigned, by using a computer-generated randomization
scheme, in a single-blind fashion to either the omentectomy (n=15) or control group (n=15).
Inclusion Criteria:
- Patients who consented to undergo LAGB for weight loss and consent to participate in
this study
- BMI ≥35 kg/m2
- Confirmed T2DM treated with oral agents and/or only diet therapy
- Age 18-64 years
Exclusion Criteria:
- Insulin therapy
- Weight change (>2% body weight) within 4 weeks before surgery
- Patients with T2DM for more than 10 years
Research Design- Pilot Study Event Week (approximate) Medical Screening (in conjunction with
routine pre-op visit) -4 OGTT & randomization -2 Preliminary genetic testing for the future
study (blood sample) -2 Surgery with or without omentectomy 0 Preliminary genetic testing
for the future study (fat sample) 0 Weight stabilization visit (in conjunction with routine
post-op visit) 2 Weight stabilization visit (in conjunction with routine post-op visit) 4
OGTT 6
STUDY PLAN
Study has approved by IRB, NYU School of Medicine Committee, GCRC, and Bellevue Hospital.
Study initiation date: November 01, 2007
Enrollment period: Nov. 2007 to Nov. 2008
Study period: Nov. 2007 to Jan 2008
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment