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Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices

This study is currently recruiting participants.
Verified by Legacy Health System, November 2007

Sponsored by: Legacy Health System
Information provided by: Legacy Health System
ClinicalTrials.gov Identifier: NCT00552942
  Purpose

To see if removing the omentum in addition to a gastric bypass improves diabetes is better than just a gastric bypass.


Condition Intervention Phase
Diabetes
Interleukins
Cytokines
Procedure: laparoscopic gastric bypass plus omentectomy
Phase III

MedlinePlus related topics:   Diabetes    Weight Control   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices

Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • diabetic indices [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • interleukin and cytokine levels, weight loss [ Time Frame: 6 months ]

Estimated Enrollment:   40
Study Start Date:   July 2006
Estimated Study Completion Date:   July 2008

Arms Assigned Interventions
1: Experimental
surgery plus omentectomy
Procedure: laparoscopic gastric bypass plus omentectomy
2: No Intervention
standard gastric bypass

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • undergoing laparoscopic gastric bypass, >18 yo, understands english

Exclusion Criteria:

  • previous lower pelvic surgery, self-pay patients, previous weight loss surgery,
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552942

Contacts
Contact: Dennis Hong, MD, MS.c, FRCSC     503-227-5050     dennishong70@gmail.com    

Locations
United States, Oregon
Oregon Weight Loss Surgery LLC     Recruiting
      Portland, Oregon, United States, 97210
      Contact: Dennis Hong, MD, MS.,c, FRCSC     503-227-5050     dennishong70@gmail.com    

Sponsors and Collaborators
Legacy Health System

Investigators
Principal Investigator:     Dennis Hong, MD., MS.c, FRCSC     Oregon Weight Loss Surgery LLC    
  More Information


Study ID Numbers:   1234
First Received:   November 1, 2007
Last Updated:   November 1, 2007
ClinicalTrials.gov Identifier:   NCT00552942
Health Authority:   United States: Institutional Review Board

Keywords provided by Legacy Health System:
obesity  
diabetes  
cytokines  

Study placed in the following topic categories:
Obesity
Diabetes Mellitus

ClinicalTrials.gov processed this record on October 07, 2008




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