Duodenal Jejunal Bypass for Type 2 Diabetes (DJBD) | NCT00487526

Studies
Duodenal Jejunal Bypass for Type 2 Diabetes (DJBD)

NCT00487526

Sponsor

Ferzli, George S., M.D. F.A.C.S.

Status

Unknown status

Last Update Posted

Jul 11, 2007Estimated

Enrollment

50Estimated

Phase

Phase 1

Conditions

Diabetes Mellitus

Interventions

duodenal jejunal bypass

Countries

Dominican Republic

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

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 11, 2007

First Submission Date that Met QC Criteria

Jun 15, 2007

First Posted Date

Jun 18, 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

Jul 10, 2007

Last Update Posted Date

Jul 11, 2007Estimated

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

Study the effect of Duodenal jejunal bypass on human adults with type 2 diabetes.

Detailed Description

Adults non obese ( BMI less than 34 ) will undergo duodenal jejunal bypass. The Outcome measures: Blood Sugar, Insulin,HbA1c, CCK,Gastrin, GIP1and 2, Ghrelin, Cholesterol, Triglycerides,FFA, C-Peptide.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
duodenal jejunal bypass	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
control of type 2 diabetes in non obese adults		two years

Secondary Outcomes

Measure	Description	Time Frame
CCK FFA,Cholesterol,Ghrelin,C-peptide,HbA1c,Gastrin,GIP,Triglycerides,Insulin		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults age 20-65
Clinical diagnosis of type 2 diabetes
Non obese with BMI less than 34.
Oral agents or insulin to control T2DM.
Inadequate control of diabetes as defined as HbA1c>/7.5
Understanding of the mechanisms of action of the treatment

Exclusion Criteria:

Children with type 1 diabetes
Obese with BMI over 34
Coagulopathy
Liver cirrhosis
Unable to comply with study requirements, follow-up or give valid consent
Currently pregnant
Previous upper abdominal surgery
Inabilty to tolerate general anesthesia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
George S Ferzli, MD, F.A.C.S	Contact	718-667-8100		GFerzli@aol.com

Overall Officials

Name	Affiliation	Role
George S Ferzli, MD F.A.C.S	SUNY Downstate	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Advance Medicine Abel Gonzalez	Recruiting	Santo Domingo			Dominican Republic

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided