A Pilot Study of Metabolic Effects of Omentectomy (OMT)
Primary Purpose
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
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omentectomy
No intervention
Sponsored by
About this trial
This is an interventional treatment trial for Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2 focused on measuring DM
Eligibility 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
Sites / Locations
- NYU School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1. Omentectomy
2 No Omentectomy
Arm Description
LAGB & Omentectomy
LAGB Only
Outcomes
Primary Outcome Measures
1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation
Secondary Outcome Measures
Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.
Full Information
NCT ID
NCT00565799
First Posted
November 28, 2007
Last Updated
November 18, 2015
Sponsor
NYU Langone Health
Collaborators
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00565799
Brief Title
A Pilot Study of Metabolic Effects of Omentectomy
Acronym
OMT
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Conflicting interim data
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
DM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Omentectomy
Arm Type
Active Comparator
Arm Description
LAGB & Omentectomy
Arm Title
2 No Omentectomy
Arm Type
Placebo Comparator
Arm Description
LAGB Only
Intervention Type
Procedure
Intervention Name(s)
Omentectomy
Intervention Description
Removing the omentum
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Only LAGB without Omentectomy
Primary Outcome Measure Information:
Title
1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation
Time Frame
6 week post op
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Ren, M.D.
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU School of Medicine
City
NY
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Links:
URL
http://nyuweightloss.org
Description
Related Info
Learn more about this trial
A Pilot Study of Metabolic Effects of Omentectomy
We'll reach out to this number within 24 hrs