Overview

Obeticholic Acid in Bariatric and Gallstone Disease

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown in laboratory animals. Obeticholic acid (OCA) is a semisynthetic bile acid with very high affinity to FXR. In a pharmacodynamic study the effects of OCA on bile acid, lipid and glucose turn-over are studied in 20 morbidly obese and 20 gallstones patents, respectively, that are administered OCA at 25 mg/day in three weeks before bariatric (BS) or gallstone (GS) surgery where in addition to blood samples also biopsies are taken from the liver and in the case of BS, omental and subcutaneous adipose tissue and in case of GS, gallbladder bile.
Phase:
Phase 2
Details
Lead Sponsor:
Sahlgrenska University Hospital, Sweden
Collaborator:
Medical University of Vienna
Treatments:
Chenodeoxycholic Acid