Quantification of trans-intestinal cholesterol excretion in patients with familial hypobetalipoproteinemia

Withdrawn

Conditions: Familial hypobetalipoproteinemia
10027424
10013317

Registration Number: NL-OMON40859

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

FHBL patients: Male; caucasian origin; 18-65 years old; documented FHBL
Healthy controls: Male; caucasian origin; 18-65 years old; matched for age, BMI and possible medication use, depending on included FHBL subjects

Exclusion Criteria

Use of cholesterol influencing medication; BMI > 35 kg/m2; Diabetes mellitus type 1 and 2; Uncontrolled hypertension; History of arterial disease including acute coronary syndrome (ACS), recent transient ischemic attacks (TIAs) or cerebro-vascular accident (CVA); Alcohol or drug abuse; Hepatic transaminases, yGT or bilirubin > 2 ULN at screening visit; History of gallstones or gallbladder resection; Having received an investigational drug in the last 3 months before the screening visit; Unable or unwilling to comply with the protocol requirements or deemed by the investigator to be unfit for the study; Likely to leave the study before its completion

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Via the quantity of cholesterol isotopes in blood, gall and feces, we will be<br /><br>able to measure how these fluxes add to the total amount of cholesterol that is<br /><br>fecally excreted.<br /><br><br /><br>The different fluxes are:<br /><br>A) dietary cholesterol that is not absorbed by the intestines<br /><br>B) cholesterol that is excreted in the feces via the blood stream<br /><br>B1) cholesterol excreted via gall<br /><br>B2) cholesterol excreted directly via the intestines<br /><br>C) cholesterol from hepatic de novo synthesis<br /><br>D) intestinal de novo cholesterol synthesis and shedding via enterocytes<br /><br><br /><br>B2 should be regarded as a derivative of TICE </p><br>

Secondary Outcome Measures