Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus
Recruitment status was Active, not recruiting
Premise: Complete resolution of Type 2 Diabetes Mellitus with normalization of blood glucose and HbA1c in the abscence of medication support is possible with a surgical procedure named the "Duodenal-Jejunal Bypass (DJB)" a modification of an established duodenal switch procedure and is performed utilizing the laparoscopic approach.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Modified Duodenal Switch Procedure "Duodenal-Jejunal Bypass" (Diabetes Surgery) As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Patients- a Pilot Project to Validate a Prospective Randomized Control Trial|
- Measure: Resolution of Type 2 Diabetes Mellitus [ Time Frame: One year ]
- Measure: Safety and efficacy of duodenal-jejunal bypass [ Time Frame: One year ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||November 2008|
Experimental: DJB patient
Patient has undergone a duodeno-jejunal bypass
Procedure: Duodenal-jejunal Bypass
Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum
Hypothesis: The duodenum plays a major role in glucose homeostasis through mechanisms largely unknown at this time. Evidence of this hypothesis comes from accumulated data in bariatric surgery patients who underwent Roux-en-y Gastric Bypass or Biliopancreatic Diversion (BPD) with or without a Duodenal Switch. Current evidence strongly supports this hypothesis with a long term (over 10 years) Type 2 Diabetes Mellitus(T2DM) resolution rate of 84-86% following the gastric bypass and over 95% for the duodenal switch.
The clinical resolution of T2DM is defined as independence of all anti-diabetic medications and maintaining a HbA1c less than 6.0. Recent rodent experiments by Francesco Rubino and subsequent human case reports by Cohen et al. supports the validity of this hypothesis. The modified procedure involved a roux-en-y bypass of the duodenum and 30-50cm of proximal jejunum, unaltering the stomach and pylorus resulted in resolution of T2DM with no weight loss in all subjects.
|United States, New York|
|Sound Shore Medical Center of Westchester|
|New Rochelle, New York, United States, 10802|
|Principal Investigator:||Leonard Maffucci, MD||Sound Shore Medical Center of Westchester|
|Principal Investigator:||Madhu S Rangraj, MD||Sound Shore Medical Center of Westchester|