Pregnane X Receptor (PXR) Agonist Rifampicin Effects on Glucose, Lipid and Hormone Homeostasis

Phase 4

Completed

• Conditions: Glucose Tolerance
• Interventions: Drug: Placebo; Drug: Rifampicin

• Registration Number: NCT00985270
• Lead Sponsor: University of Oulu

Brief Summary

This clinical trial is designed to study the effects of rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin lowers fasting glucose and enhances insulin sensitivity. The study is a randomized, placebo-controlled, open-label cross-over trial. Twelve subjects will be given 600 mg of rifampicin a day for a week compared to a one-week placebo arm. There is at least a 4-week wash-out between the arms. The main outcome measures are the changes in the fasting glucose and HOMA-IR-index (calculated based on fasting glucose and insulin).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-25
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-09
• Last Update Posted: 2011-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy volunteer
• Age 18-40 years

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Rifampicin	Rifampicin	-

Primary Outcome Measures

Name	Time	Method
Fasting glucose

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland