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

Glucose Metabolism Clinical Trial

— Rifa-2  

Official title:

PXR-aktivaation Vaikutukset Sokeri-, Kolesteroli- ja Hormonitasapainoon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293422
• Other study ID #: Rifa-2
• Secondary ID: 2010-023662-47
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2011
• Last updated: September 7, 2012
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glucose Metabolism

Intervention

Drug:
• Rifampicin
Rifampicin 600 mg daily for a week

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose levels during oral glucose tolerance test			No