Liraglutide Blood-brain TransferLIRA-CSVNCT02104037
Liraglutide in Spinal Fluid
A study testing Lumbar puncture in people with Liraglutide Blood-brain Transfer, run by Mikkel Christensen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate transfer of liraglutide from blood to cerebrospinal fluid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liraglutide Blood-brain Transfer
- What is being tested?
- Lumbar puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Dec 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes treated with liraglutide 1.8 mg for 1 month and 5% weight loss
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Diabetes Research Division, Department of Medicine
Hellerup, 2900
About this study
The purpose of this study is to investigate transfer of liraglutide from blood to cerebrospinal fluid.
- Conditions
- Liraglutide Blood-brain Transfer
- Being tested
- Lumbar puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar punctureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide treated patients | Experimental | Not described Receives: Procedure: Lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebrospinal fluid concentration of liraglutide
Measured: time 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liraglutide Blood-brain TransferStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikkel Christensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mikkel Christensen, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104037
- Sponsor's protocol ID
- H-2-2011-027
- Acronym
- LIRA-CSV
- Status last verified
- Apr 2014
- First submitted
- 1 Apr 2014
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide in Spinal Fluid
- ClinicalTrials.gov ID
- NCT02104037
- Acronym / sponsor ID
- LIRA-CSV / H-2-2011-027
- Conditions
- Liraglutide Blood-brain Transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mikkel ChristensenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- First posted
- 4 Apr 2014 (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.
The purpose of this study is to investigate transfer of liraglutide from blood to cerebrospinal fluid.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide treated patients | Experimental | Procedure: Lumbar puncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes treated with liraglutide 1.8 mg for 1 month and 5% weight loss
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Lumbar puncture | Procedure or surgery | Liraglutide treated patients |
Primary outcome
cerebrospinal fluid concentration of liraglutide
Time frame: time 60 minutes
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 4 Apr 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar puncture in people with Liraglutide Blood-brain Transfer, run by Mikkel Christensen at 1 site in Denmark.
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 1 inclusion and 1 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 4 Apr 2014. 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 Denmark. 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.
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?
cerebrospinal fluid concentration of liraglutide (time frame: time 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2014.