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

This study has been completed.
Sponsor:
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT00985270
First received: September 25, 2009
Last updated: February 9, 2011
Last verified: February 2011

September 25, 2009
February 9, 2011
September 2009
October 2010   (final data collection date for primary outcome measure)
Fasting glucose
Same as current
Complete list of historical versions of study NCT00985270 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Pregnane X Receptor (PXR) Agonist Rifampicin Effects on Glucose, Lipid and Hormone Homeostasis
PXR-agonisti Rifampisiinin Vaikutukset Glukoosi-, Lipidi- ja Hormonihomeostaasiin

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Glucose Tolerance
  • Drug: Rifampicin
    Other Name: Rimapen, ATC J04AB02
  • Drug: Placebo
  • Active Comparator: Rifampicin
    Intervention: Drug: Rifampicin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00985270
Rifampisiini01
No
Janne Hukkanen, Oulu University Hospital
University of Oulu
Not Provided
Principal Investigator: Janne Hukkanen, MD, PhD Oulu University Hospital
University of Oulu
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP