Duodenal Exclusion for the Treatment of T2DM
This study has been completed.
Sponsor:
Covidien
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00456352
First received: April 2, 2007
Last updated: January 26, 2011
Last verified: January 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 2, 2007 | ||||||||
| Last Updated Date | January 26, 2011 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Treatment success based on patients' glycemic control. [ Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Treatment success based on patients' glycemic control. | ||||||||
| Change History | Complete list of historical versions of study NCT00456352 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Physiologic measurements, Comorbidity improvement, Improvement in QOL. [ Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Physiologic measurements, Comorbidity improvement, Improvement in QOL. | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Duodenal Exclusion for the Treatment of T2DM | ||||||||
| Official Title ICMJE | Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes Mellitus (T2DM) | ||||||||
| Brief Summary | Evaluation of duodenal exclusion procedure for the treatment of T2DM |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Diabetes | ||||||||
| Intervention ICMJE | Procedure: duodenal exclusion | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| 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 | Completed | ||||||||
| Enrollment ICMJE | 37 | ||||||||
| Completion Date | October 2010 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00456352 | ||||||||
| Other Study ID Numbers ICMJE | AS07004 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Ross Segan, MD, Global Medical Director, Covidien | ||||||||
| Study Sponsor ICMJE | Covidien | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Covidien | ||||||||
| Verification Date | January 2011 | ||||||||
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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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