Expired Study
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New Rochelle, New York 10802


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.


Study summary:

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.


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.


NCT ID:

NCT00562029


Primary Contact:

Principal Investigator
Leonard Maffucci, MD
Sound Shore Medical Center of Westchester


Backup Contact:

N/A


Location Contact:

New Rochelle, New York 10802
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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