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

This study has been completed.
Maffucci L, Rangraj M
Information provided by (Responsible Party):
Sound Shore Medical Center of Westchester Identifier:
First received: November 19, 2007
Last updated: May 19, 2015
Last verified: May 2015

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.

Condition Intervention
Type 2 Diabetes Mellitus
Procedure: Duodenal-jejunal Bypass

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Sound Shore Medical Center of Westchester:

Primary Outcome Measures:
  • Measure: Resolution of Type 2 Diabetes Mellitus [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure: Safety and efficacy of duodenal-jejunal bypass [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: November 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00562029

United States, New York
Sound Shore Medical Center of Westchester
New Rochelle, New York, United States, 10802
Sponsors and Collaborators
Sound Shore Medical Center of Westchester
Maffucci L, Rangraj M
Principal Investigator: Leonard Maffucci, MD Sound Shore Medical Center of Westchester
Principal Investigator: Madhu S Rangraj, MD Sound Shore Medical Center of Westchester
  More Information

Additional Information:
Responsible Party: Sound Shore Medical Center of Westchester Identifier: NCT00562029     History of Changes
Other Study ID Numbers: djb-2007
Study First Received: November 19, 2007
Last Updated: May 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Sound Shore Medical Center of Westchester:
Diabetes Mellitus
Duodenal Bypass
Surgical Procedures

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on October 02, 2015