Status:
UNKNOWN
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes
Lead Sponsor:
Ferzli, George S., M.D. F.A.C.S.
Conditions:
Type II Diabetes
Eligibility:
All Genders
20-65 years
Brief Summary
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, Choleste...
Eligibility Criteria
Inclusion
- Adults age 20-65 years
- Clinical diagnosis of type II diabetes buy on of the following three criteria (American Diabetes Association)
- A normal or high C-peptide level (to exclude type 1 diabetes) (\>.9ng/ml)
- A random plasma glucose of 200mg/dl or more with typical symptom of diabetes
- 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
- 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)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00694278
Start Date
June 1 2008
Last Update
June 10 2008
Active Locations (1)
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1
Lutheran Medical Center
Brooklyn, New York, United States, 11220