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The Effects of PXR Activation on Hepatic Fat Content

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Rifampicin
Placebo
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Non-alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers
  • Body mass index (BMI) 18.5-25 kg/m2

Exclusion Criteria:

  • Systolic blood pressure over 150 mmHg
  • Any continuous medication (hormonal intrauterine device is permitted)
  • Any significant medical condition
  • Insensitivity to rifampicin
  • Pregnancy and lactation
  • Previous difficult venipuncture
  • Alcohol and medicine abuse and drug use
  • Participation to any other pharmaceutical trial within on month of screening
  • Claustrophobia
  • Metal and other implants which are contraindications to MRI

Sites / Locations

  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rifampicin

Placebo

Arm Description

Rifampicin 600 mg tablet once a day orally for a week.

Placebo tablet once a day orally for a week.

Outcomes

Primary Outcome Measures

Hepatic fat fraction

Secondary Outcome Measures

Full Information

First Posted
December 29, 2014
Last Updated
October 31, 2017
Sponsor
University of Oulu
Collaborators
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02329405
Brief Title
The Effects of PXR Activation on Hepatic Fat Content
Official Title
PXR-aktivaation Vaikutus Maksan Rasvoittumiseen
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
Collaborators
Oulu University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers. Hepatic fat content is measured with magnetic resonance imaging and blood samples are collected at the end of each study arm. The investigators' hypothesis is that rifampicin causes accumulation of fat to the liver.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifampicin
Arm Type
Experimental
Arm Description
Rifampicin 600 mg tablet once a day orally for a week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet once a day orally for a week.
Intervention Type
Drug
Intervention Name(s)
Rifampicin
Other Intervention Name(s)
Rifampin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Hepatic fat fraction
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Body mass index (BMI) 18.5-25 kg/m2 Exclusion Criteria: Systolic blood pressure over 150 mmHg Any continuous medication (hormonal intrauterine device is permitted) Any significant medical condition Insensitivity to rifampicin Pregnancy and lactation Previous difficult venipuncture Alcohol and medicine abuse and drug use Participation to any other pharmaceutical trial within on month of screening Claustrophobia Metal and other implants which are contraindications to MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janne Hukkanen, MD, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029 OYS
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35229613
Citation
Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.
Results Reference
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The Effects of PXR Activation on Hepatic Fat Content

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