Start Date
November 30, 2014
Primary Completion Date
April 30, 2015
Study Completion Date
April 30, 2015
Mix Nutrient Meal
Before Surgery: Subjects will have a visit where they will have a mixed nutrient stimulation test. They will be asked to fast for 12 hours prior to this visit (except water). During the visit they will drink an 8 ounce mixed nutrient liquid meal in 5 minute intervals over 20 minutes. During this visit a catheter will be placed in a vein in their arm for blood sample collections. A total of 50 ml of blood will be collected, (10 ml before drinking the mixed nutrient drink, at 30 minutes, at 60 minutes, at 90 minutes and 120 minutes after the mixed nutrient drink).
labs
Fasting Plasma Glucose (FPG) and insulin will be added to the standard pre-operative labs.
Biopsy
Intra-operatively: Subjects will undergo a standard laparoscopic Roux-en-Y Gastric Bypass (RYGB). During the surgery a 2cm tissue sample of the Roux limb will be taken by the doctor and frozen.
Second Mix Nutrient Meal
2 months post-operatively a second mixed nutrient stimulation test will be performed following the same process used pre-operatively.
Second biopsy
. Patients will also be scheduled to undergo a second upper endoscopy and a 2cm biopsy of the Roux limb will be taken by the doctor and frozen in liquid nitrogen.
PET/CT
Lastly, subjects will have a positron emission tomography/computed tomography (PET/CT) scan with Fluorodeoxyglucose (FDG) to evaluate the glucose in the Roux limb after surgery.
Lead Sponsor
Society of American Gastrointestinal and Endoscopic Surgeons
OTHER
Duke University
OTHER