A Pilot Study of Metabolic Effects of Omentectomy - Full Text View

Sponsors and Collaborators:	New York University School of Medicine Washington University School of Medicine
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00565799

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).

Condition	Intervention	Phase
Patients Who Consented to Undergo LAGB for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2 Confirmed T2DM Treated With Oral Agents and/or Only Diet Therapy Age 18-64 Years	Procedure: Omentectomy Other: No intervention	Phase II

MedlinePlus related topics: Diabetes Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation [ Time Frame: 6 week post op ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 6 week post op ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
1. Omentectomy: Active Comparator LAGB & Omentectomy	Procedure: Omentectomy Removing the omentum
2 No Omentectomy: Placebo Comparator LAGB Only	Other: No intervention Only LAGB without Omentectomy

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

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565799

Contacts

Contact: Allison Youn, MA

212 263 2174

younh01@med.nyu.edu

Locations

United States, New York
NYU School of Medicine	Recruiting
NY, New York, United States, 10016
Contact: Allison Youn, MA 212-263-2174 younh01@med.nyu.edu
Principal Investigator: Christine Ren, M.D.

Sponsors and Collaborators

New York University School of Medicine

Washington University School of Medicine

Investigators

Principal Investigator:

Christine Ren, M.D.

NYU School of Medicine

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	NYU School of Medicine/ Bariatric Surgery ( Christine Ren, M.D. )
Study ID Numbers:	07-178, Ren 07-178
Study First Received:	November 28, 2007
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00565799
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

DM

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Diabetes Mellitus, Type 2
Body Weight Changes
Diabetes Mellitus

ClinicalTrials.gov processed this record on January 15, 2009