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Completed

NCT Number: NCT00562029

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sound Shore Medical Center of Westchester

New Rochelle, New York, 10802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duodenal-jejunal Bypass

Procedure

Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum

Primary outcomes

  1. Measure: Resolution of Type 2 Diabetes Mellitus

    Time frame: One year

Secondary outcomes

  1. Measure: Safety and efficacy of duodenal-jejunal bypass

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Sound Shore Medical Center of Westchester

Other

Collaborators

  • Maffucci L, Rangraj M

Registry information

Official study 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

Acronym: DJB

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Nov 21, 2007
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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