A Pilot Study of Metabolic Effects of Omentectomy | NCT00565799

Studies
A Pilot Study of Metabolic Effects of Omentectomy

NCT00565799

Sponsor

NYU Langone Health

Status

Terminated

Last Update Posted

Nov 20, 2015Estimated

Enrollment

11Actual

Phase

Phase 2

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

Interventions

Omentectomy
No intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Conflicting interim data

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Nov 28, 2007

First Submission Date that Met QC Criteria

Nov 28, 2007

First Posted Date

Nov 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2015

Last Update Posted Date

Nov 20, 2015Estimated

Name	Class
Washington University School of Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. Omentectomy	Active Comparator	LAGB & Omentectomy	Procedure: Omentectomy
2 No Omentectomy	Placebo Comparator	LAGB Only	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omentectomy	Procedure	Removing the omentum	1. Omentectomy
No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation		6 week post op

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christine Ren, M.D.	NYU School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU School of Medicine		New York	New York	10016	United States

References Module

Citations

Not provided