in Vivo TICE (TransIntestinal Cholesterol Excretion)
Not Applicable
- Conditions
- Occlusion of Bile Duct With an External Bile Diversion.
- Interventions
- Other: Intravenous injection of deuterated cholesterol diluted in intralipid 20%
- Registration Number
- NCT01958216
- Lead Sponsor
- Nantes University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 5
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trans-intestinal cholesterol excretion in vivo Intravenous injection of deuterated cholesterol diluted in intralipid 20% Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients
- Primary Outcome Measures
Name Time Method Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients Day 3 Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital
🇫🇷Nantes, France