Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes
Status: | Recruiting |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 20 - 65 |
Updated: | 4/2/2016 |
Start Date: | June 2008 |
Contact: | George Ferzli, MD |
Email: | gferzli@lmcmc.com |
Phone: | 718-630-7351 |
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
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
1
site
Click here to add this to my saved trials