Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans
Glucose Intolerance, Gastric Bypass Surgery
About this trial
This is an interventional basic science trial for Glucose Intolerance focused on measuring Glucose, Ileostomy
Eligibility Criteria
Inclusion Criteria:
- Able to give informed consent
- Presence of an ileostomy > 2 months
- Weight stable* for >2 months (i.e. no greater than 7% change in body weight the last 2 months)
Exclusion Criteria:
- Crohn's Disease
- Steroid use in the last 3 months
- Documented/known diagnosis of type 1 diabetes or type 2 diabetes, chronic liver disease, chronic kidney disease, heart failure, cardiac dysrhythmias, or familial hypercholesterolemia
- Current use of any over-the-counter or prescription oral bile salt
- Currently pregnant
- Current use of medications that are known to interact with Ursodiol
- Current or former smoker within the last year.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Ursodeoxycholic Acid/Placebos
Placebos/Ursodeoxycholic Acid
During one of the subjects two randomized visits the subject will receive a 300mg elixir solution of ursodeoxycholic acid (UDCA) via their ileostomy that has been prepared by investigational drug services (IDS) in a 5cc elixir formulation during visit #1. During visit #2 subjects will receive a saline solution of totaling 5cc via their ileostomy that has been prepared by investigational drug services (IDS) in order to mimic the preparation of the medication comparator of ursodeoxycholic acid.
Subjects will receive a saline solution of totaling 5cc via their ileostomy that has been prepared by investigational drug services (IDS) in order to mimic the preparation of the medication comparator of ursodeoxycholic acid during visit #1. During visit #2 subject will receive a 300mg elixir solution of ursodeoxycholic acid (UDCA) via their ileostomy that has been prepared by investigational drug services (IDS) in a 5cc elixir formulation.