in Vivo TICE (TransIntestinal Cholesterol Excretion)

Overview

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.

Full Title of Study: “In Vivo TICE (TransIntestinal Cholesterol Excretion) Measurement in Bile Duct Diverted Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2015

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: Trans-intestinal cholesterol excretion in vivo
    • Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bertrand Cariou, Pofessor, Principal Investigator, Nantes University Hospital
  • Overall Contact(s)
    • Bertrand CARIOU, Professor, +33 (0)2 53 48 27 07, bertrand.cariou@univ-nantes.fr

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