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

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ClinicalTrials.gov Identifier: NCT00985270
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : February 10, 2011
Sponsor:
Information provided by:
University of Oulu

Tracking Information
First Submitted Date  ICMJE September 25, 2009
First Posted Date  ICMJE September 28, 2009
Last Update Posted Date February 10, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2009)
Fasting glucose
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00985270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pregnane X Receptor (PXR) Agonist Rifampicin Effects on Glucose, Lipid and Hormone Homeostasis
Official Title  ICMJE PXR-agonisti Rifampisiinin Vaikutukset Glukoosi-, Lipidi- ja Hormonihomeostaasiin
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Glucose Tolerance
Intervention  ICMJE
  • Drug: Rifampicin
    Other Name: Rimapen, ATC J04AB02
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Rifampicin
    Intervention: Drug: Rifampicin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 25, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00985270
Other Study ID Numbers  ICMJE Rifampisiini01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janne Hukkanen, Oulu University Hospital
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janne Hukkanen, MD, PhD Oulu University Hospital
PRS Account University of Oulu
Verification Date February 2011

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