Occlusion of Bile Duct With an External Bile Diversion.in vivoTICENCT01958216
in Vivo TICE (TransIntestinal Cholesterol Excretion)
A study testing Intravenous injection of deuterated cholesterol diluted in intralipid 20% in people with Occlusion of Bile Duct With an External Bile Diversion., run by Nantes University Hospital at 1 site in France.
Trial summary
So far, the liver has been the main target for cholesterol elimination. However, several recent studies performed in mice have described a new route of cholesterol excretion, the Trans-Intestinal Cholesterol Excretion or TICE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occlusion of Bile Duct With an External Bile Diversion.
- What is being tested?
- Intravenous injection of deuterated cholesterol diluted in intralipid 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Apr 2015
- 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
- External bile duct diverted patients
Who cannot join
- Inflammatory bowel disease
- Aphagia
- Renal or hepatocellular insufficiency
- Primary intestinal tumor
- Cholangitis or severe sepsis
- Acute or chronic diarrhea
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Nantes, 44000
Bertrand Cariou, Professor, +33 (0)2 53 48 27 07, bertrand.cariou@univ-nantes.fr
Bertrand Cariou, Professor
About this study
Official title: In Vivo TICE (TransIntestinal Cholesterol Excretion) Measurement in Bile Duct Diverted Patients
So far, the liver has been the main target for cholesterol elimination. However, several recent studies performed in mice have described a new route of cholesterol excretion, the Trans-Intestinal Cholesterol Excretion or TICE. TICE allows direct elimination of plasma cholesterol in the feces directly via the intestine. Until now, only indirect evidence suggests that TICE is also active in humans, the goal of this proof of concept study is to provide the first proof of its existence in humans by using stable isotopes in patients with bile duct diversion.
- Being tested
- Intravenous injection of deuterated cholesterol diluted in intralipid 20%
- Keywords
- TICE-human-stable isotopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous injection of deuterated cholesterol diluted in intralipid 20%Other
At day 0, bile diverted patients will receive an intravenous injection of deuterated cholesterol diluted in intralipid 20%. The plasma, biliary and fecal content of deuterated cholesterol will be measured, by mass spectrometry, at 24, 48 and 72 hours after the initial input.
| Study group | Role | What they receive |
|---|---|---|
| Trans-intestinal cholesterol excretion in vivo | Other | Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients Receives: Other: Intravenous injection of deuterated cholesterol diluted in intralipid 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients
Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occlusion of Bile Duct With an External Bile Diversion.Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Cariou, Pofessor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958216
- Sponsor's protocol ID
- RC11_0008
- Acronym
- in vivoTICE
- Status last verified
- Sep 2013
- First submitted
- 30 Sep 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moreau F, Blanchard C, Perret C, Flet L, Douane F, Frampas E, Mirallie E, Croyal M, Aguesse A, Krempf M, Prieur X, Pichelin M, Cariou B, Le May C. In vivo evidence for transintestinal cholesterol efflux in patients with complete common bile duct obstruction. J Clin Lipidol. 2019 Jan-Feb;13(1):213-217.e1. doi: 10.1016/j.jacl.2018.09.010. Epub 2018 Sep 21.
PubMed 30342919
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo TICE (TransIntestinal Cholesterol Excretion) Measurement in Bile Duct Diverted Patients
- ClinicalTrials.gov ID
- NCT01958216
- Acronym / sponsor ID
- in vivoTICE / RC11_0008
- Keywords
- TICE-human-stable isotopes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 9 Oct 2013 (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.
So far, the liver has been the main target for cholesterol elimination. However, several recent studies performed in mice have described a new route of cholesterol excretion, the Trans-Intestinal Cholesterol Excretion or TICE. TICE allows direct elimination of plasma cholesterol in the feces directly via the intestine. Until now, only indirect evidence suggests that TICE is also active in humans, the goal of this proof of concept study is to provide the first proof of its existence in humans by using stable isotopes in patients with bile duct diversion.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans-intestinal cholesterol excretion in vivo | Other | Other: Intravenous injection of deuterated cholesterol diluted in intralipid 20%Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- External bile duct diverted patients
Key exclusion criteria (6 listed)
- Inflammatory bowel disease
- Aphagia
- Renal or hepatocellular insufficiency
- Primary intestinal tumor
- Cholangitis or severe sepsis
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 |
|---|---|---|
| Intravenous injection of deuterated cholesterol diluted in intralipid 20%At day 0, bile diverted patients will receive an intravenous injection of deuterated cholesterol diluted in intralipid 20%. The plasma, biliary and fecal content of deuterated cholesterol will be measured, by mass spectrometry, at 24, 48 and 72 hours after the initial input. | Other | Trans-intestinal cholesterol excretion in vivo |
Primary outcome
Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients
Time frame: Day 3
Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
- Derived from this study: PubMed 30342919Moreau F, Blanchard C, Perret C, Flet L, Douane F, Frampas E, Mirallie E, Croyal M, Aguesse A, Krempf M, Prieur X, Pichelin M, Cariou B, Le May C. In vivo evidence for transintestinal cholesterol efflux in patients with complete common bile duct obstruction. J Clin Lipidol. 2019 Jan-Feb;13(1):213-217.e1. doi: 10.1016/j.jacl.2018.09.010. Epub 2018 Sep 21.
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.
Bertrand Cariou, Pofessor principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous injection of deuterated cholesterol diluted in intralipid 20% in people with Occlusion of Bile Duct With an External Bile Diversion., run by Nantes University Hospital at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 9 Oct 2013. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrand CARIOU, Professor (+33 (0)2 53 48 27 07, bertrand.cariou@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients (time frame: Day 3). 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 NCT01958216, which also lists 1 linked publication.
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 9 Oct 2013.