Neuroendocrine Brake for Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00450710|
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : August 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Procedure: ileal interposition with a sleeve gastrectomy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV Study of Neuroendocrine Brake Surgical Procedure for Type 2 Diabetes Mellitus|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2009|
- Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy.
- Evaluate neurohormonal effect in treating T2DM.
- Improvement or control of blood glucose levels.
- Improvement or control of comorbidities associated with T2DM.
- Hormonal effect and effect of the operations on diabetes related and total mortality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450710
|Hospital de Especialidades|
|Study Director:||Noreen A Gannon||Medtronic - MITG|
|Principal Investigator:||Aureo DePaula, MD||Hospital de Especialidades|