The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

January 6, 2018

Study Completion Date

January 6, 2018

Conditions
Type 2 Diabetes MellitusObesity
Interventions
PROCEDURE

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.

BEHAVIORAL

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.

DRUG

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."

DRUG

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."

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER

NCT02762708 - The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes | Biotech Hunter | Biotech Hunter