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

Glucose Tolerance Clinical Trial

Official title:

PXR-agonisti Rifampisiinin Vaikutukset Glukoosi-, Lipidi- ja Hormonihomeostaasiin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985270
• Other study ID #: Rifampisiini01
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2009
• Last updated: February 9, 2011
• Start date: September 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glucose Tolerance

Intervention

Drug:
• Rifampicin

• Placebo

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	Fasting glucose