Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
11 participants
INTERVENTIONAL
2007-11-30
2010-11-30
Brief Summary
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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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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1. Omentectomy
LAGB \& Omentectomy
Omentectomy
Removing the omentum
2 No Omentectomy
LAGB Only
No intervention
Only LAGB without Omentectomy
Interventions
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Omentectomy
Removing the omentum
No intervention
Only LAGB without Omentectomy
Eligibility Criteria
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Inclusion Criteria
* BMI ≥35 kg/m2
* Confirmed T2DM treated with oral agents and/or only diet therapy
* Age 18-64 years
Exclusion Criteria
* Weight change (\>2% body weight) within 4 weeks before surgery
* Patients with T2DM for more than 10 years
18 Years
64 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Christine Ren, M.D.
Role: PRINCIPAL_INVESTIGATOR
NYU School of Medicine
Locations
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NYU School of Medicine
New York, New York, United States
Countries
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Related Links
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Related Info
Other Identifiers
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07-178
Identifier Type: -
Identifier Source: org_study_id