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.


Study is Available At:


Original ID:

djb-2007


NCT ID:

NCT00562029


Secondary ID:


Study Acronym:

DJB


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sound Shore Medical Center of Westchester


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:November 2007
Completion Date:December 2011
Completion Type:Actual
Primary Completion Date:December 2011
Primary Completion Type:Actual
Verification Date:May 2015
Last Changed Date:May 19, 2015
First Received Date:November 19, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Measure: Safety and efficacy of duodenal-jejunal bypass
Time Frame:One year
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Measure: Resolution of Type 2 Diabetes Mellitus
Time Frame:One year
Safety Issues:True

Study Interventions

Intervention Type:Procedure
Name:Duodenal-jejunal Bypass
Description:Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum
Arm Name:DJB patient

Study Arms

Study Arm Type:Experimental
Arm Name:DJB patient
Description:Patient has undergone a duodeno-jejunal bypass

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Sound Shore Medical Center of Westchester
Agency Class:Other
Agency Type:Collaborator
Agency Name:Maffucci L, Rangraj M

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Cohen RV, Schiavon CA, Pinheiro JS et al. Duodeno-jejunal bypass for 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.
Reference Type:Results Reference
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.
PMID:17386391
Reference Type:Reference
Citation: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.
PMID:15479938
Reference Type:Reference
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.
PMID:17060767

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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