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A Pilot Study of Metabolic Effects of Omentectomy (OMT)

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ClinicalTrials.gov Identifier: NCT00565799
Recruitment Status : Terminated (Conflicting interim data)
First Posted : November 30, 2007
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
New York University School of Medicine

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).


Condition or disease Intervention/treatment Phase
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 Procedure: Omentectomy Other: No intervention Phase 2

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)
Study Start Date : November 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation [ Time Frame: 6 week post op ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00565799     History of Changes
Other Study ID Numbers: 07-178
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

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