in Vivo TICE (TransIntestinal Cholesterol Excretion) (in vivoTICE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01958216
First received: September 30, 2013
Last updated: October 8, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Occlusion of Bile Duct With an External Bile Diversion.
Other: Intravenous injection of deuterated cholesterol diluted in intralipid 20%

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: In Vivo TICE (TransIntestinal Cholesterol Excretion) Measurement in Bile Duct Diverted Patients

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients


Estimated Enrollment: 5
Study Start Date: September 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Trans-intestinal cholesterol excretion in vivo
Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958216

Contacts
Contact: Bertrand CARIOU, Professor +33 (0)2 53 48 27 07 bertrand.cariou@univ-nantes.fr
Contact: Cedric LE MAY, Doctor +33 (0)2 28 08 01 66 Cedric.Lemay@univ-nantes.fr

Locations
France
University Hospital Recruiting
Nantes, France, 44000
Contact: Bertrand Cariou, Professor    +33 (0)2 53 48 27 07    bertrand.cariou@univ-nantes.fr   
Principal Investigator: Bertrand Cariou, Professor         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Bertrand Cariou, Pofessor Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01958216     History of Changes
Other Study ID Numbers: RC11_0008
Study First Received: September 30, 2013
Last Updated: October 8, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
TICE-human-stable isotopes

Additional relevant MeSH terms:
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 22, 2014