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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Sound Shore Medical Center of Westchester.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sound Shore Medical Center of Westchester
ClinicalTrials.gov Identifier:
NCT00562029
First received: November 19, 2007
Last updated: June 11, 2009
Last verified: April 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

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

Estimated Enrollment: 10
Study Start Date: November 2007
Estimated Study Completion Date: November 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562029

Locations
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
Investigators
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:
click here for information on background to present study  This link exits the ClinicalTrials.gov site

Publications:
Cohen RV, Schiavon CA, Pinheiro JS et al. Duodeno-jejunal bypass for treatment of type 2 diabetes in patients with body mass index of 22-34 kg/m2: a report of 2 cases. Surg Obes Relat Dis. 2007 Mar-Apr; 3(2): 195-7.

ClinicalTrials.gov Identifier: NCT00562029     History of Changes
Other Study ID Numbers: djb-2007
Study First Received: November 19, 2007
Last Updated: June 11, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013