Pregnane X Receptor (PXR) Agonist Rifampicin Effects on Glucose, Lipid and Hormone Homeostasis
Information source: University of Oulu
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glucose Tolerance
Intervention: Rifampicin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Oulu Official(s) and/or principal investigator(s):
Janne Hukkanen, MD, PhD, Principal Investigator, Affiliation: Oulu University Hospital
Overall contact:
Janne Hukkanen, MD, PhD, Phone: +35883156212, Email: janne.hukkanen@oulu.fi
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).
Clinical Details
Official title: PXR-agonisti Rifampisiinin Vaikutukset Glukoosi-, Lipidi- ja Hormonihomeostaasiin
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Fasting glucose
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
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
Locations and Contacts
Janne Hukkanen, MD, PhD, Phone: +35883156212, Email: janne.hukkanen@oulu.fi
Oulu University Hospital, Oulu 90220, Finland; Recruiting
Additional Information
Starting date: September 2009
Last updated: September 25, 2009
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