Hepatic 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…
ID
Bron
Verkorte titel
Aandoening
Non-alcoholic fatty liver disease; NAFLD; Steatosis; CAP; Controlled Attenuation Parameter; FibroScan; Niet-alcoholische leververvetting; Steatose;
Ondersteuning
Professor of Radiology
Department of Radiology
Academic Medical Center Amsterdam
Professor of Radiology
Department of Radiology
Academic Medical Center Amsterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Effect of a standardized amount of fat intake on CAP-values.
Achtergrond van het onderzoek
CAPtivating 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).
Doel van het onderzoek
Hepatic 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®.
Onderzoeksopzet
1. 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.
Onderzoeksproduct en/of interventie
In 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.
Publiek
Academic Medical Center<br>
Meibergdreef 9
Jurgen Runge
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662251
j.h.runge@amc.uva.nl
Wetenschappelijk
Academic Medical Center<br>
Meibergdreef 9
Jurgen Runge
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662251
j.h.runge@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Male or Female Sex;
2. 18 years or older;
3. FibroScan-measurement possible with M-probe;
4. No history of liver disease.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL3669 |
NTR-old | NTR3839 |
CCMO | NL41865.018.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON41661 |