Type 2 Diabetes Mellitus Clinical Trial
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
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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