Duodenal Jejunal Bypass for Type 2 Diabetes (DJBD)

NCT ID: NCT00487526

Last Updated: 2007-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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duodenal jejunal bypass

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDIV

Sponsor Role lead

Principal Investigators

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George S Ferzli, MD F.A.C.S

Role: PRINCIPAL_INVESTIGATOR

SUNY Downstate

Locations

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Center for Advance Medicine Abel Gonzalez

Santo Domingo, , Dominican Republic

Site Status RECRUITING

Countries

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Dominican Republic

Central Contacts

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George S Ferzli, MD, F.A.C.S

Role: CONTACT

718-667-8100

Facility Contacts

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Abel Gonzalez, MD

Role: primary

809 543 79 81

Role: backup

809 227 22 35

Other Identifiers

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AS07006

Identifier Type: -

Identifier Source: org_study_id