Neuroendocrine Brake for Type 2 Diabetes Mellitus
This study has been completed.
Information provided by:
First received: March 21, 2007
Last updated: October 16, 2009
Last verified: October 2009
Evaluation to determine the safety of two laparoscopic procedures to control T2DM.
Procedure: ileal interposition with a sleeve gastrectomy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Phase IV Study of Neuroendocrine Brake Surgical Procedure for Type 2 Diabetes Mellitus|
Resource links provided by NLM:
Further study details as provided by Covidien:
Primary Outcome Measures:
- Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy.
Secondary Outcome Measures:
- 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.
|Study Start Date:||March 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
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