A Pilot Study of Metabolic Effects of Omentectomy

Stopped early · Phase 2

Conditions studied: 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

In brief

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).

Key facts

Study ID

NCT00565799

Run by

NYU Langone Health

People needed

11

Starts

2007-11-01

Expected to finish

2010-11-01

Last updated by the study team

2015-11-20

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• NYU School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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