Expired Study
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NY, New York 10016


Purpose:

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).


Study summary:

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


Criteria:

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


Study is Available At:


Original ID:

07-178


NCT ID:

NCT00565799


Secondary ID:


Study Acronym:

OMT


Brief Title:

A Pilot Study of Metabolic Effects of Omentectomy


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)


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

64 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York University School of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Conflicting interim data


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

11


Enrollment Type:

Actual


Overall Contact Information

Official Name:Christine Ren, M.D.
Principal Investigator
NYU School of Medicine

Study Dates

Start Date:November 2007
Completion Date:November 2010
Completion Type:Actual
Primary Completion Date:November 2010
Primary Completion Type:Actual
Verification Date:November 2015
Last Changed Date:November 18, 2015
First Received Date:November 28, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation
Time Frame:6 week post op
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Procedure
Name:Omentectomy
Description:Removing the omentum
Arm Name:1. Omentectomy
Intervention Type:Other
Name:No intervention
Description:Only LAGB without Omentectomy
Arm Name:2 No Omentectomy

Study Arms

Study Arm Type:Active Comparator
Arm Name:1. Omentectomy
Description:LAGB & Omentectomy
Study Arm Type:Placebo Comparator
Arm Name:2 No Omentectomy
Description:LAGB Only

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York University School of Medicine
Agency Class:Other
Agency Type:Collaborator
Agency Name:Washington University School of Medicine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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