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

Type 2 Diabetes Mellitus Clinical Trial

— DJB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562029
• Other study ID #: djb-2007
• Status: Completed
• Phase: N/A
• First received: November 19, 2007
• Last updated: May 19, 2015
• Start date: November 2007
• Est. completion date: December 2011

Study information

• Verified date: May 2015
• Source: Sound Shore Medical Center of Westchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• Duodenal-jejunal Bypass
Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum

Locations

Country	Name	City	State
United States	Sound Shore Medical Center of Westchester	New Rochelle	New York

Sponsors (2)

Lead Sponsor	Collaborator
Sound Shore Medical Center of Westchester	Maffucci L, Rangraj M

Country where clinical trial is conducted

United States, 

References & Publications (4)

Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728. — View Citation

Cohen RV, Schiavon CA, Pinheiro JS, Correa JL, Rubino F. Duodenal-jejunal bypass for the 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. — View Citation

Cummings DE, Overduin J, Foster-Schubert KE, Carlson MJ. Role of the bypassed proximal intestine in the anti-diabetic effects of bariatric surgery. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):109-15. Review. — View Citation

Rubino F, Forgione A, Cummings DE, Vix M, Gnuli D, Mingrone G, Castagneto M, Marescaux J. The mechanism of diabetes control after gastrointestinal bypass surgery reveals a role of the proximal small intestine in the pathophysiology of type 2 diabetes. Ann Surg. 2006 Nov;244(5):741-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Resolution of Type 2 Diabetes Mellitus		One year	Yes
Secondary	Measure: Safety and efficacy of duodenal-jejunal bypass		One year	Yes

External Links

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