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Obeticholic Acid in Bariatric and Gallstone Disease

NCT01625026 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-10-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Obeticholic acid

Obeticholic acid 25 mg/day in three weeks

DRUG

Placebo

Placebo to obeticholic acid

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Hanns-Ulrich Marschall, MD, PhD · Sahlgrenska University Hospital Gothenburg

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01625026 on ClinicalTrials.gov