Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Procedure: Duodenal-jejunal Bypass


Participation Criteria
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Eligibility Criteria
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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 HIV 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 Endocrinopathies: acromegaly, glucagonoma, Cushing's Syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldorestanoma Chemical Induced Diabetes: vacor, pentamidine, nicotinic acid, glucocorticoids, thyroid hormones, diazoxide, beta-adrenergic agonists, thiazides, phenytoin, alfa-interferon Genetic Syndromes with Diabetes: Down's, Klinefelter's, Turner's, Wolfram, Lawrence-Moon- Beidel, Prader-Willi, Friederich's ataxia, Huntington's Chorea, Myotonic Dystrophy, Porphyria, If a candidate is deemed to be not an appropriate candidate based on investigators recommendation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DJB patient<br>Patient has undergone a duodeno-jejunal bypass | Procedure: Duodenal-jejunal Bypass<br>* Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Resolution of Type 2 Diabetes Mellitus |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Safety and efficacy of duodenal-jejunal bypass |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Surgery, Duodenal Bypass, Resolution, Surgical Procedures