Expired Study
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Brooklyn, New York 11220


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


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)


NCT ID:

NCT00694278


Primary Contact:

Study Chair
George Ferzli, MD
Lutheran Medical Center

George Ferzli, MD
Phone: 718-630-7351
Email: gferzli@lmcmc.com


Backup Contact:

N/A


Location Contact:

Brooklyn, New York 11220
United States

George Ferzli, MD
Phone: 718-630-7351

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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