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Effects of Pregnane X Receptor (PXR) Activation on Human Glucose, Lipid and Hormone Homeostasis

NCT ID: NCT01293422

Last Updated: 2012-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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This clinical trial is designed to study the effects of pregnane X receptor activator rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin raises postprandial glucose studied with oral glucose tolerance test. The study is a non-randomized, one-phase, open-label trial. Twelve subjects will be given 600 mg of rifampicin a day for a week. The main outcome measures are the changes in the glucose and insulin levels during oral glucose tolerance test.

Detailed Description

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Conditions

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Glucose Metabolism

Keywords

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PXR, glucose, cholesterol

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Rifampicin

Group Type EXPERIMENTAL

Rifampicin

Intervention Type DRUG

Rifampicin 600 mg daily for a week

Interventions

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Rifampicin

Rifampicin 600 mg daily for a week

Intervention Type DRUG

Other Intervention Names

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Rimapen, ATC J04AB02

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer
* Age 18-45 years
* Body mass index 19-28

Exclusion Criteria

* Any continuous medication
* Any significant disease
* Allergy to rifampicin
* Pregnancy and breast feeding
* Fear of needles and previous difficult blood samplings
* Substance abuse
* Participation in another clinical drug trial within 1 month of enrollment
* Use of soft contact lenses
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janne Hukkanen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 35229613 (View on PubMed)

Other Identifiers

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2010-023662-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Rifa-2

Identifier Type: -

Identifier Source: org_study_id