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The effect of a standardized amount of fat on the CAP-value for non-invasively measuring liver fat content.


- candidate number14327
- NTR NumberNTR3839
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-feb-2013
- Secondary IDsNL41865.018.12 / 2012_310 CCMO / METC AMC
- Public TitleThe effect of a standardized amount of fat on the CAP-value for non-invasively measuring liver fat content.
- Scientific TitleEvaluation of the effect of a standardized amount of fat on the CAP-value for quantitating liver steatosis.
- ACRONYMCAPtivating
- hypothesisHepatic steatosis is becoming a large health burden in both Western and non-Western societies. There is a need for specific diagnostic tools that can distinguish between patients with significant steatosis and those without whilst simultaneously quantifying the amount of steatosis. Quantification will help clinicians to guide therapy. Several tools exist, but all suffer from shortcomings. A new tool for quantifying steatosis is the Controlled Attenuation Parameter (CAP), available on the FibroScan® (a device used to determine the presence of liver fibrosis). This tool gives a continuous outcome measure and has thus far been evaluated mainly against semi-quantitative scoring of liver biopsies and not against other continuous outcome measures such as 1H-MR Spectroscopy or MRI based liver fat-maps. Neither has the effect of meals on the CAP-value been investigated. In this study, we hypothesize that the ingestion of a standardized amount of fat (cream) does not influence the CAP-value as measured with the FibroScan®.
- Healt Condition(s) or Problem(s) studiedNon alcoholic steato hepatitis (NASH), Steatosis, FibroScan
- Inclusion criteria1. Male or Female Sex;
2. 18 years or older;
3. FibroScan-measurement possible with M-probe;
4. No history of liver disease.
- Exclusion criteria1. Alcohol consumption of >3 units per day for male and >2 units per day for females;
2. Focal liver lesion(s) in the right liver lobe (proven with histology results or imaging);
3. Start of or change in treatment of liver disease less than 4 weeks before visit 1;
4. Fibroscan®/CAP examination not possible with M-probe;
5. Dairy intolerance;
6. CAP-value of 300 dB m-1 or more at screening.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2013
- planned closingdate30-nov-2014
- Target number of participants8
- InterventionsIn this cohort, 8 fasting subjects will be given cream (35 grams fat / 100 ml) to drink as a fat challenge. Subjects will be given 30 grams of fat per square meter of body surface area, calculated with the DuBois-DeBois method. Before administration and hourly up to six hours after administration CAP-measurements will be performed to ascertain whether a fatty meal induces changes in the CAP-value.
- Primary outcomeEffect of a standardized amount of fat intake on CAP-values.
- Secondary outcomeSerum Triglyceride levels (at least first 3 subjects).
- Timepoints1. CAP-values with FibroScan device (measured at screening, baseline and hourly up to six hours after ingestion of cream as a fat challenge);
2. Serum Triglyceride levels: Blood drawn out baseline and hourly up to six hours after ingestion of cream as a fat challenge.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Jurgen Runge
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J. Stoker
- Sponsor/Initiator Academic Medical Center (AMC), Department of Radiology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Radiology
- PublicationsN/A
- Brief summaryCAPtivating is a study in which the CAP-measurement of liver fat content is compared to two reference standards for liver fat: histology and MR-based liver fat fractions. In this part of the study, 8 healthy subjects with no fatty livers are measured with CAP before and hourly up to six hours after ingestion of cream as a fatty meal challenge to investigate the influence of meals on the CAP-measurement.

All subjects are recruited in the Netherlands (in the AMC).
- Main changes (audit trail)
- RECORD5-feb-2013 - 13-feb-2013


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