A Pilot Study of Metabolic Effects of Omentectomy (OMT)
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).
|Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2 Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy Age 18-64 Years||Procedure: Omentectomy Other: No intervention||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|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)|
- 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation [ Time Frame: 6 week post op ]
- Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study. [ Time Frame: 6 week post op ]
|Study Start Date:||November 2007|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1. Omentectomy
LAGB & Omentectomy
Removing the omentum
Placebo Comparator: 2 No Omentectomy
Other: No intervention
Only LAGB without Omentectomy
- 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
- 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565799
|United States, New York|
|NYU School of Medicine|
|NY, New York, United States, 10016|
|Principal Investigator:||Christine Ren, M.D.||NYU School of Medicine|