Albumin Catabolic Rate Measured by a Stable Isotope
ConditionLiver Disease Chronic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorAke Norberg
About this trial
The goal of this physiological study is to compare albumin catabolic rate measured by a stable isotope labeled amino acid in healthy volunteers and in patients with liver disease. At steady state synthesis and catabolism or degradation are equal.
The primary questions it aims to answer are:
* Is albumin catabolic rate lower in patients with liver disease? * Is albumin catabolic rate measured by stable isotopes in volunteers like historical controls measured by radio-iodinated albumin at the investigator's laboratory or elsewhere? Subjects will be given an oral dose of the deuterium labeled amino acid phenylalanine that will be incorporated by the liver in newly synthetized albumin molecules, and blood samples will be taken over 12 weeks to determine the catabolic rate of albumin.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
males and females >= 40 years (to be more like the anticipated age of the liver patients)
good peripheral blood vessels
written informed consent
known compensated liver cirrhosis with radiological or endoscopic signs of portal hypertension, such as varices, splenomegaly, or shunts.
Disqualifiers
Planned surgical procedure within 3 months (due to possible blood loss i.e. loss of tracer)
Pregnancy at dosing
Phenylketonuria
Participating in other study with stable isotopes within 60 days.
Trial design
Design model
Parallel
Treatments tested in this trial
stable isotopes
Other interventionThe tracer 2H5-phenylalanine is an essential amino acid labeled with deuterium that is a stable isotope, i.e. no radiation is emitted, but the tracer can still be assessed by a combination of gas chromatography and mass spectrometry. The tracer has no measurable effects, but are used for assessment of human physiology.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Patients with liver diseaseExperimental treatment 1 intervention
Group B: Healthy volunteers with no signs of liver diseaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Albumin degradation rate by stable isotope
The disappearance rate of 2H5-phenylalanine labeled albumin over time, that is the catabolic rate of albumin, will be measured in both study groups in blood samples over 12 weeks, and the study groups compared.
Time frame
12 weeks2
Albumin degradation rate by different methods
Healthy volunteers will be compared to historical controls from our laboratory where albumin degradation rate was measured by radio-iodinated human serum albumin.
Time frame
12 weeksSecondary outcomes
1
Albumin synthesis rate
We will compare the oral flooding dose with historical controls where the isotope was given intravenously at our laboratory for measurement of albumin synthesis rates in volunteers and patients with liver disease.
Time frame
120 minutes2
Albumin degradation by modeling different fractions of oxidized albumin over time
During the life span of the albumin molecule more and more oxidation appears. The doubly oxidized molecule can no longer reverse to unoxidized albumin. We want to investigate if rations of labeled to unlabeled fractions of the different forms of oxidized albumin can be used for modeling albumin degradation rate
Time frame
12 weeks3
Correlation between oxidation and degradation rate of albumin
Oxidation of albumin molecules has been reported to be increased in liver disease. We want to see if there is a correlation between oxidation fraction and albumin degradation rate.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ake Norberg
Lead sponsor
Karolinska Institutet
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: