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

• Conditions: Type II Diabetes

• Registration Number: NCT00694278
• Lead Sponsor: Ferzli, George S., M.D. F.A.C.S.

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, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be followed closely to ensure the desired results are sustained in long term

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-06
• Study Start: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-05
• Last Update Submitted: 2008-06-05
• Study First Posted: 2008-06-10
• Last Update Posted: 2008-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Lutheran Medical Center; 🇺🇸 Brooklyn, New York, United States