NCT00985270CompletedPhase 4
PXR-agonisti Rifampisiinin Vaikutukset Glukoosi-, Lipidi- ja Hormonihomeostaasiin
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Oulu
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Fasting glucose
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Rifampicin
Active Comparator
Intervention: Rifampicin (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Fasting glucose
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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