A Pilot Study of Metabolic Effects of Omentectomy

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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A Pilot Study of Metabolic Effects of Omentectomy in Obese Patients With Type 2 Diabetes Mellitus Treated With Laparoscopic Adjustable Gastric Banding (LAGB)

Conditions
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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

Intervention / Treatment
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* Procedure: Omentectomy
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Omentectomy<br>LAGB & Omentectomy | Procedure: Omentectomy<br>* Removing the omentum<br>|
| Placebo Comparator: 2 No Omentectomy<br>LAGB Only | Other: No intervention<br>* Only LAGB without Omentectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation |  | 6 week post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study. |  | 6 week post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DM