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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00487526
Recruitment Status : Unknown
Verified July 2007 by Ferzli, George S., M.D. F.A.C.S..
Recruitment status was:  Recruiting
First Posted : June 18, 2007
Last Update Posted : July 11, 2007
Information provided by:
Ferzli, George S., M.D. F.A.C.S.

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Procedure: duodenal jejunal bypass Phase 1

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Effect of Duodenal Jejunal Bypass on Type Two Diabetes in Non Obese Adults
Study Start Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. control of type 2 diabetes in non obese adults [ Time Frame: two years ]

Secondary Outcome Measures :
  1. CCK FFA,Cholesterol,Ghrelin,C-peptide,HbA1c,Gastrin,GIP,Triglycerides,Insulin [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487526

Contact: George S Ferzli, MD, F.A.C.S 718-667-8100 GFerzli@aol.com

Dominican Republic
Center for Advance Medicine Abel Gonzalez Recruiting
Santo Domingo, Dominican Republic
Contact: Abel Gonzalez, MD    809 543 79 81    abelcayo@yahoo.com   
Contact    809 227 22 35      
Sponsors and Collaborators
Ferzli, George S., M.D. F.A.C.S.
Principal Investigator: George S Ferzli, MD F.A.C.S SUNY Downstate

ClinicalTrials.gov Identifier: NCT00487526     History of Changes
Other Study ID Numbers: AS07006
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: July 11, 2007
Last Verified: July 2007

Keywords provided by Ferzli, George S., M.D. F.A.C.S.:
Duodenal jejunal
type 2 diabetes
non-obese adults

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases