in Vivo TICE (TransIntestinal Cholesterol Excretion)

Occlusion of Bile Duct With an External Bile Diversion. Clinical Trial

— in vivoTICE  

Official title:

In Vivo TICE (TransIntestinal Cholesterol Excretion) Measurement in Bile Duct Diverted Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01958216
• Other study ID #: RC11_0008
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2013
• Last updated: October 8, 2013
• Start date: September 2013
• Est. completion date: April 2015

Study information

• Verified date: September 2013
• Source: Nantes University Hospital
• Contact: Bertrand CARIOU, Professor
• Phone: +33 (0)2 53 48 27 07
• Email: bertrand.cariou[@]univ-nantes.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cholestasis
• Occlusion of Bile Duct With an External Bile Diversion.

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients	Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients	Day 3	No