12
Participants
Start Date
March 31, 2016
Primary Completion Date
January 6, 2018
Study Completion Date
January 6, 2018
Roux-en-Y Gastric Bypass (RYGB)
Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery.
Caloric Restriction
Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.
Exendin-9,39
"A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
Normal Saline
"subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
Mayo Clinic in Rochester, Rochester
Lead Sponsor
Mayo Clinic
OTHER