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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Procedure: Duodenal-jejunal Bypass

• Registration Number: NCT00562029
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-21
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DJB patient	Duodenal-jejunal Bypass	Patient has undergone a duodeno-jejunal bypass

Primary Outcome Measures

Name	Time	Method
Measure: Resolution of Type 2 Diabetes Mellitus	One year

Secondary Outcome Measures

Name	Time	Method
Measure: Safety and efficacy of duodenal-jejunal bypass	One year

Trial Locations

Locations (1)

Sound Shore Medical Center of Westchester; 🇺🇸 New Rochelle, New York, United States