Glucose MetabolismPhase 4Rifa-2NCT01293422
Effects of Pregnane X Receptor (PXR) Activation on Human Glucose, Lipid and Hormone Homeostasis
A Phase 4 study testing Rifampicin in people with Glucose Metabolism, run by University of Oulu at 1 site in Finland.
Trial summary
This clinical trial is designed to study the effects of pregnane X receptor activator rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin raises postprandial glucose studied with oral glucose tolerance test. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism
- What is being tested?
- Rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2011to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
- Age 18-45 years
- Body mass index 19-28
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: PXR-aktivaation Vaikutukset Sokeri-, Kolesteroli- ja Hormonitasapainoon
This clinical trial is designed to study the effects of pregnane X receptor activator rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin raises postprandial glucose studied with oral glucose tolerance test. The study is a non-randomized, one-phase, open-label trial. Twelve subjects will be given 600 mg of rifampicin a day for a week. The main outcome measures are the changes in the glucose and insulin levels during oral glucose tolerance test.
- Conditions
- Glucose Metabolism
- Being tested
- Rifampicin
- Keywords
- PXR, glucose, cholesterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampicinDrug
Also called Rimapen, ATC J04AB02
Rifampicin 600 mg daily for a week
| Study group | Role | What they receive |
|---|---|---|
| Rifampicin | Experimental | Not described Receives: Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels during oral glucose tolerance test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glucose MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janne Hukkanen, MD, PhD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293422
- Sponsor's protocol ID
- Rifa-2
- Other IDs
- 2010-023662-47
- Acronym
- Rifa-2
- Status last verified
- Sep 2012
- First submitted
- 9 Feb 2011
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Rahunen R, Merikallio H, Rinne V, Savolainen MJ, Hukkanen J. Hypertension in Overweight and Obesity: Sex-Specific Role of 4beta-Hydroxycholesterol. J Am Heart Assoc. 2026 Mar 3;15(5):e043913. doi: 10.1161/JAHA.125.043913. Epub 2026 Feb 26.
PubMed 41744113Rahunen 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.
PubMed 35229613
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PXR-aktivaation Vaikutukset Sokeri-, Kolesteroli- ja Hormonitasapainoon
- ClinicalTrials.gov ID
- NCT01293422
- Acronym / sponsor ID
- Rifa-2 / Rifa-2
- Conditions
- Glucose Metabolism
- Keywords
- PXR, glucose, cholesterol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is designed to study the effects of pregnane X receptor activator rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin raises postprandial glucose studied with oral glucose tolerance test. The study is a non-randomized, one-phase, open-label trial. Twelve subjects will be given 600 mg of rifampicin a day for a week. The main outcome measures are the changes in the glucose and insulin levels during oral glucose tolerance test.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rifampicin | Experimental | Drug: Rifampicin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteer
- Age 18-45 years
- Body mass index 19-28
Key exclusion criteria (8 listed)
- Any continuous medication
- Any significant disease
- Allergy to rifampicin
- Pregnancy and breast feeding
- Fear of needles and previous difficult blood samplings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifampicinAlso: Rimapen, ATC J04AB02Rifampicin 600 mg daily for a week | Drug | Rifampicin |
Primary outcome
Glucose levels during oral glucose tolerance test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
- Derived from this study: PubMed 41744113Rahunen R, Merikallio H, Rinne V, Savolainen MJ, Hukkanen J. Hypertension in Overweight and Obesity: Sex-Specific Role of 4beta-Hydroxycholesterol. J Am Heart Assoc. 2026 Mar 3;15(5):e043913. doi: 10.1161/JAHA.125.043913. Epub 2026 Feb 26.
- Derived from this study: PubMed 35229613Rahunen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne Hukkanen, MD, PhD principal investigator
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifampicin in people with Glucose Metabolism, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose levels during oral glucose tolerance test. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01293422, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.