Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 30, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Type 2 DiabetesObesity
Interventions
OTHER

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).

OTHER

labs

Fasting Plasma Glucose (FPG) and insulin will be added to the standard pre-operative labs.

OTHER

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.

OTHER

Second Mix Nutrient Meal

2 months post-operatively a second mixed nutrient stimulation test will be performed following the same process used pre-operatively.

OTHER

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.

DEVICE

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.

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Society of American Gastrointestinal and Endoscopic Surgeons

OTHER

lead

Duke University

OTHER

NCT02288351 - Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass | Biotech Hunter | Biotech Hunter