Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes

Therapuetic Areas:Endocrinology
Age Range:20 - 65
Start Date:June 2008
Contact:George Ferzli, MD

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Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes in Adults

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

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)
We found this trial at
Brooklyn, New York 11220
Brooklyn, NY
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