NCT00434525

Brief Summary

  • The investigators aim to determine the clinical and metabolic effects of sleeve gastrectomy with or without omentectomy in the treatment of morbid obesity.
  • The investigators hypothesize that the endocrine suppression of ghrelin (appetite hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits for morbidly obese patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 15, 2009

Status Verified

August 1, 2009

Enrollment Period

1.9 years

First QC Date

February 9, 2007

Last Update Submit

December 14, 2009

Conditions

Morbid Obesity

Keywords

Morbid obesityBariatric SurgeryObesity SurgeryOmentectomySleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    5 years

Secondary Outcomes (2)

  • Metabolic outcomes

    5 years

  • Diabetes resolution

    5 years

Study Arms (2)

1 Sleeve gastrectomy with omentectomy

EXPERIMENTAL
Procedure: Laparoscopic restrictive procedure

2 Sleeve gastrectomy

ACTIVE COMPARATOR
Procedure: Sleeve gastrectomy

Interventions

Laparoscopic restrictive procedurePROCEDURE

Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy

1 Sleeve gastrectomy with omentectomy
Sleeve gastrectomyPROCEDURE

Sleeve gastrectomy

2 Sleeve gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Morbidly obese VETERANS ONLY (BMI\>35 with comorbidities or BMI\>40)
  • Age \> 18

You may not qualify if:

  • Pregnancy
  • Uncontrolled medical or psychiatric conditions
  • Previous bariatric procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA North Texas

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Esteban Varela, MD, MPH

    VA North Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 13, 2007

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 15, 2009

Record last verified: 2009-08

Locations

US(1)