Physiologic and Functional Adaptations of Insulin Sensitive Tissues

Enrolling by invitationOBSERVATIONAL
Enrollment

500

Participants

Timeline

Start Date

February 13, 2018

Primary Completion Date

February 29, 2028

Study Completion Date

February 29, 2028

Conditions
DiabetesInsulin ResistanceObesityBariatric Surgery CandidateRoux-en-y Gastric BypassLiver Diseases
Interventions
OTHER

Endoscopy biopsy

Tissue samples will be collected from the jejunum, duodenum, and colon during the subject's standard of care procedure.

OTHER

Surgical biopsy

Biopsy of the liver is standard of care for diagnosing NAFLD. Biopsy of omentum, skeletal muscle and subcutaneous adipose (the latter two tissues taken at the site of trocar placement) will be collected intraoperatively at the time of Roux-en-Y gastric bypass (RYGB) or vertical sleeve gastrectomy (VSG).

OTHER

Mixed-meal tolerance test

The mixed meal tolerance test (MMTT) shows how much insulin your body is making after drinking a liquid meal beverage that contains fats, protein and carbohydrates (sugar). Glucose, C-peptide, free fatty acids, triglycerides, incretins, pancreatic polypertide, bile aceis, and fatty acid amides can also be measured. A total of 9 tablespoons of blood is taken over a 255 minute period.

OTHER

Excised Liver Tissue Sampling

Tissue will be collected from the excised liver for research after the diseased liver has been removed as part of the standard of care procedure.

Trial Locations (1)

37232

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER