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Duodenal Jejunal Bypass for Type 2 Diabetes (DJBD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Ferzli, George S., M.D. F.A.C.S..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ferzli, George S., M.D. F.A.C.S.
ClinicalTrials.gov Identifier:
NCT00487526
First received: June 11, 2007
Last updated: July 10, 2007
Last verified: July 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
 Procedure: duodenal jejunal bypass
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Effect of Duodenal Jejunal Bypass on Type Two Diabetes in Non Obese Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ferzli, George S., M.D. F.A.C.S.:

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

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

Estimated Enrollment: 50
Study Start Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487526

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

Locations
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.
Investigators
Principal Investigator: George S Ferzli, MD F.A.C.S SUNY Downstate
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00487526     History of Changes
Other Study ID Numbers: AS07006
Study First Received: June 11, 2007
Last Updated: July 10, 2007
Health Authority: Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013