A Pilot Study of Metabolic Effects of Omentectomy

NCT00565799 | Terminated Phase 2 DMC

• 1 other identifier: 07-178
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation

  6 week post op

Secondary Outcomes (1)

• Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.

  6 week post op

Study Arms (2)

1. Omentectomy

ACTIVE COMPARATOR

LAGB \& Omentectomy

Procedure: Omentectomy

2 No Omentectomy

PLACEBO COMPARATOR

LAGB Only

Other: No intervention

Interventions

Omentectomy PROCEDURE

Removing the omentum

1. Omentectomy

No intervention OTHER

Only LAGB without Omentectomy

2 No Omentectomy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Insulin therapy
• Weight change (\>2% body weight) within 4 weeks before surgery
• Patients with T2DM for more than 10 years

Sponsors & Collaborators

• NYU Langone Health: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

Related Links

• Related Info

Study Officials

• Christine Ren, M.D.

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 30, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

US (1)