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
Recruitment status was Recruiting
Sponsor:
Legacy Health System
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
| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 2007 | ||||
| Last Updated Date | November 1, 2007 | ||||
| Start Date ICMJE | July 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
diabetic indices [ Time Frame: 6 months ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
interleukin and cytokine levels, weight loss [ Time Frame: 6 months ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices | ||||
| Official Title ICMJE | Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices | ||||
| Brief Summary | To see if removing the omentum in addition to a gastric bypass improves diabetes is better than just a gastric bypass. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: laparoscopic gastric bypass plus omentectomy | ||||
| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | July 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00552942 | ||||
| Other Study ID Numbers ICMJE | 1234 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Legacy Health System | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Legacy Health System | ||||
| Verification Date | November 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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