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A Pilot Study of Metabolic Effects of Omentectomy (OMT)

This study has been terminated.
(Comflicting interim data)
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00565799
First received: November 28, 2007
Last updated: March 18, 2010
Last verified: March 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

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 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Omentectomy
LAGB & Omentectomy
 Procedure: Omentectomy
Removing the omentum
Placebo Comparator: 2 No Omentectomy
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

Locations
United States, New York
NYU School of Medicine
NY, New York, United States, 10016
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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Christine Ren, M.D., NYU School of Medicine/ Bariatric Surgery
ClinicalTrials.gov Identifier: NCT00565799     History of Changes
Other Study ID Numbers: 07-178, Ren 07-178
Study First Received: November 28, 2007
Last Updated: March 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
DM

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Weight Loss
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013