Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure... | NCT00562029

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

NCT00562029

Sponsor

Sound Shore Medical Center of Westchester

Status

Completed

Last Update Posted

May 21, 2015Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes Mellitus

Interventions

Duodenal-jejunal Bypass

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Nov 19, 2007

First Submission Date that Met QC Criteria

Nov 19, 2007

First Posted Date

Nov 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2015

Last Update Posted Date

May 21, 2015Estimated

Name	Class
Maffucci L, Rangraj M	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DJB patient	Experimental	Patient has undergone a duodeno-jejunal bypass	Procedure: Duodenal-jejunal Bypass

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Duodenal-jejunal Bypass	Procedure	Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum	DJB patient

Measure	Description	Time Frame
Measure: Resolution of Type 2 Diabetes Mellitus		One year

Measure	Description	Time Frame
Measure: Safety and efficacy of duodenal-jejunal bypass		One year

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonard Maffucci, MD	Sound Shore Medical Center of Westchester	Principal Investigator
Madhu S Rangraj, MD	Sound Shore Medical Center of Westchester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sound Shore Medical Center of Westchester		New Rochelle	New York	10802	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17060767	Background	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. doi: 10.1097/01.sla.0000224726.61448.1b.
15479938

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases