Neuroendocrine Brake for Type 2 Diabetes Mellitus
|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)|
|Estimated 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|
|Primary Completion Date :||September 2008|
|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.
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|