NCT00985270

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 10, 2011

Status Verified

February 1, 2011

Enrollment Period

1.1 years

First QC Date

September 25, 2009

Last Update Submit

February 9, 2011

Conditions

Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • Fasting glucose

Study Arms (2)

Rifampicin

ACTIVE COMPARATOR
Drug: Rifampicin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

RifampicinDRUG
Also known as: Rimapen, ATC J04AB02
Rifampicin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteer
  • Age 18-40 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

Location

Related Publications (1)

  • Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.

    PMID: 35229613DERIVED

MeSH Terms

Interventions

Rifampin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Janne Hukkanen, MD, PhD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 28, 2009

Study Start

September 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 10, 2011

Record last verified: 2011-02

Locations

FI(1)