Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes
This study is currently recruiting participants.
Verified by Ferzli, George S., M.D. F.A.C.S., June 2008
Sponsored by: Ferzli, George S., M.D. F.A.C.S.
Information provided by: Ferzli, George S., M.D. F.A.C.S.
ClinicalTrials.gov Identifier: NCT00694278
  Purpose

The aim of this study and the primary outcome is to clinically evaluate effect of laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be followed closely to ensure the desired results are sustained in long term


Condition Phase
Type II Diabetes
Phase 0

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Cross-Sectional
Official Title: Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes in Adults

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

Estimated Enrollment: 15
Study Start Date: June 2008
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

primary care office

Criteria

Inclusion Criteria:

  • Adults age 20-65 years
  • Clinical diagnosis of type II diabetes buy on of the following three criteria (American Diabetes Association)

    1. A normal or high C-peptide level (to exclude type 1 diabetes) (>.9ng/ml)
    2. A random plasma glucose of 200mg/dl or more with typical symptom of diabetes
    3. A fasting plasma glucose of 126mg/dl or more on more than one occasion
  • BMI 22-34 KG/m2
  • Patients on oral hypoglycemic medications or insulin to control T2DM
  • Inadequate control of diabetes as defined as HbA1c>7.5
  • No contraindication for surgery or General Anesthesia as determined by multidisciplinary surgical team
  • Ability to understand and describe the mechanism of action of ricks and benefits of the operation

Exclusion Criteria:

  • Patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study
  • Enrolled in another clinical study which involves and investigational drug
  • Diagnosis type 1 diabetes
  • Pregnancy (all female patients will have beta HCG) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method
  • Previous gastric or esophageal surgery
  • Immunosuppressive drugs including corticosteroids
  • Coagulopathy (INR>1.5 or platelets<50,000/ul)
  • Anemia (Hgb<10.0g/dl)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694278

Contacts
Contact: George Ferzli, MD 718-630-7351 gferzli@lmcmc.com

Locations
United States, New York
Lutheran Medical Center Recruiting
Brooklyn, New York, United States, 11220
Contact: George Ferzli, MD     718-630-7351        
Sponsors and Collaborators
Ferzli, George S., M.D. F.A.C.S.
Investigators
Study Chair: George Ferzli, MD Lutheran Medical Center
  More Information

Responsible Party: Lutheran Medical Center ( Georger Ferzli M.D F.A.C.S. )
Study ID Numbers: LMC95
Study First Received: June 5, 2008
Last Updated: June 5, 2008
ClinicalTrials.gov Identifier: NCT00694278  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009