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

Status unconfirmed

Conditions studied: Type II Diabetes

In brief

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

Key facts

Study ID

NCT00694278

Run by

Ferzli, George S., M.D. F.A.C.S.

People needed

15

Starts

2008-06-01

Last updated by the study team

2008-06-10

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Lutheran Medical Center — Brooklyn, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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