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in Vivo TICE (TransIntestinal Cholesterol Excretion)

NCT ID: NCT01958216

Last Updated: 2013-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Occlusion of Bile Duct With an External Bile Diversion.

Keywords

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TICE-human-stable isotopes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Trans-intestinal cholesterol excretion in vivo

Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients

Group Type OTHER

Intravenous injection of deuterated cholesterol diluted in intralipid 20%

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- External bile duct diverted patients

Exclusion Criteria

* Inflammatory bowel disease
* Aphagia
* Renal or hepatocellular insufficiency
* Primary intestinal tumor
* Cholangitis or severe sepsis
* Acute or chronic diarrhea
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bertrand Cariou, Pofessor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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University Hospital

Nantes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Bertrand CARIOU, Professor

Role: CONTACT

Phone: +33 (0)2 53 48 27 07

Email: [email protected]

Cedric LE MAY, Doctor

Role: CONTACT

Phone: +33 (0)2 28 08 01 66

Email: [email protected]

Facility Contacts

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Bertrand Cariou, Professor

Role: primary

References

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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.

Reference Type DERIVED
PMID: 30342919 (View on PubMed)

Other Identifiers

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RC11_0008

Identifier Type: -

Identifier Source: org_study_id