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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Legacy Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Legacy Health System
ClinicalTrials.gov Identifier:
NCT00552942
First received: November 1, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices

Resource links provided by NLM:


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
Experimental: 1
surgery plus omentectomy
Procedure: laparoscopic gastric bypass plus omentectomy
No Intervention: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Legacy Health System:
obesity
diabetes
cytokines

ClinicalTrials.gov processed this record on September 16, 2014