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
  Purpose

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).


Condition Intervention Phase
Glucose Tolerance
Drug: Rifampicin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: PXR-agonisti Rifampisiinin Vaikutukset Glukoosi-, Lipidi- ja Hormonihomeostaasiin

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Fasting glucose

Estimated Enrollment: 12
Study Start Date: September 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rifampicin Drug: Rifampicin
Other Name: Rimapen, ATC J04AB02
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985270

Locations
Finland
Oulu University Hospital
Oulu, Finland, 90220
Sponsors and Collaborators
University of Oulu
Investigators
Principal Investigator: Janne Hukkanen, MD, PhD Oulu University Hospital
  More Information

No publications provided

Responsible Party: Janne Hukkanen, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT00985270     History of Changes
Other Study ID Numbers: Rifampisiini01
Study First Received: September 25, 2009
Last Updated: February 9, 2011
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014