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

University of Oulu

Status and phase: Completed; Phase 4

Conditions: Glucose Tolerance

Treatments: Drug: Rifampicin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00985270

Rifampisiini01

Details and patient eligibility

About

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).

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups, including a placebo group

Rifampicin

Active Comparator group

Treatment:

Drug: Rifampicin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo