A Pilot Study of Metabolic Effects of Omentectomy

Age 18-64 Years Clinical Trial

— OMT  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00565799
• Other study ID #: 07-178
• Status: Terminated
• Phase: Phase 2
• First received: November 28, 2007
• Last updated: November 18, 2015
• Start date: November 2007
• Est. completion date: November 2010

Study information

• Verified date: November 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Age 18-64 Years
• Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy
• Diabetes Mellitus, Type 2
• Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI =35 kg/m2
• Weight Loss

Intervention

Procedure:
• Omentectomy
Removing the omentum

Other:
• No intervention
Only LAGB without Omentectomy

Locations

Country	Name	City	State
United States	NYU School of Medicine	NY	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation		6 week post op	Yes
Secondary	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	Yes

External Links

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