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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sound Shore Medical Center of Westchester
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Measure: Resolution of Type 2 Diabetes Mellitus
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Established diagnosis of Type 2 diabetes mellitus
- •Body Mass Index(BMI) less than 35
- •Insulin usage duration less than 10 years
- •Negative anti-GAD
- •Fasting C-peptide level over 1.0 mcg/ml
- •Ability and willingness to follow up for a period of 1 year
- •Willingness to consent for utilizing personal results without individual identifier information to be published in medical studies and other media as determined by the study investigators
- •Ability to understand and describe the risks, benefits and mechanism of action of the procedure
Exclusion Criteria
- •Current pregnancy or positive pregnancy test
- •Liver Cirrhosis
- •Coagulopathy
- •Type 1 Diabetes Mellitus
- •Previous abdominal surgery preventing laparoscopy
- •Previous vagotomy
- •Previous gastric or small intestine surgery
- •Inability to comply with study requirements
- •Currently active medical malpractice lawsuit/s
- •Diseases of the exocrine pancreas: pancreatitis trauma, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis
Outcomes
Primary Outcomes
Measure: Resolution of Type 2 Diabetes Mellitus
Time Frame: One year
Secondary Outcomes
- Measure: Safety and efficacy of duodenal-jejunal bypass(One year)