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

July 10, 2007 updated by: Ferzli, George S., M.D. F.A.C.S.

Clinical Evaluation of the Effect of Duodenal Jejunal Bypass on Type Two Diabetes in Non Obese Adults

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: George S Ferzli, MD, F.A.C.S
  • Phone Number: 718-667-8100
  • Email: GFerzli@aol.com

Study Locations

  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Recruiting
        • Center for Advance Medicine Abel Gonzalez
        • Contact:
        • Contact:
          • Phone Number: 809 227 22 35

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: George S Ferzli, MD F.A.C.S, SUNY Downstate

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 15, 2007

First Posted (Estimate)

June 18, 2007

Study Record Updates

Last Update Posted (Estimate)

July 11, 2007

Last Update Submitted That Met QC Criteria

July 10, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS07006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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