Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes
NCT ID: NCT00694278
Last Updated: 2008-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
15 participants
OBSERVATIONAL
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
20 Years
65 Years
ALL
Yes
Sponsors
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Ferzli, George S., M.D. F.A.C.S.
INDIV
Responsible Party
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Lutheran Medical Center
Principal Investigators
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George Ferzli, MD
Role: STUDY_CHAIR
Lutheran Medical Center
Locations
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Lutheran Medical Center
Brooklyn, New York, United States
Countries
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Central Contacts
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Facility Contacts
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George Ferzli, MD
Role: primary
Other Identifiers
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LMC95
Identifier Type: -
Identifier Source: org_study_id