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Trial record 1 of 47 for:    diabetes and New Rochelle
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Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus (DJB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562029
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : May 21, 2015
Maffucci L, Rangraj M
Information provided by (Responsible Party):
Sound Shore Medical Center of Westchester

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Procedure: Duodenal-jejunal Bypass Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Measure: Resolution of Type 2 Diabetes Mellitus [ Time Frame: One year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00562029

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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
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Principal Investigator: Leonard Maffucci, MD Sound Shore Medical Center of Westchester
Principal Investigator: Madhu S Rangraj, MD Sound Shore Medical Center of Westchester
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Sound Shore Medical Center of Westchester Identifier: NCT00562029    
Other Study ID Numbers: djb-2007
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by Sound Shore Medical Center of Westchester:
Diabetes Mellitus
Duodenal Bypass
Surgical Procedures
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases