NCT05956015

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Aug 2023Dec 2028

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 28, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

4.8 years

First QC Date

July 13, 2023

Last Update Submit

July 23, 2023

Conditions

Liver Disease Chronic

Keywords

albumin catabolism

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 weeks

  • 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.

    12 weeks

Secondary Outcomes (3)

  • Albumin synthesis rate

    120 minutes

  • Albumin degradation by modeling different fractions of oxidized albumin over time

    12 weeks

  • Correlation between oxidation and degradation rate of albumin

    12 weeks

Study Arms (2)

Patients with liver disease

EXPERIMENTAL

patients with chronic liver disease will receive a oral dose of a stable isotope labeled amino acid, 2H5-Phenylalanine, (45 mg/kg body weight 50% MPE). Blood samples will be taken over 12 weeks.

Other: stable isotopes

Healthy volunteers with no signs of liver disease

EXPERIMENTAL

Healthy volunteers with no signs of liver disease will receive a oral dose of a stable isotope labeled amino acid, 2H5-Phenylalanine, (45 mg/kg body weight 50% MPE). Blood samples will be taken over 12 weeks.

Other: stable isotopes

Interventions

stable isotopesOTHER

The 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.

Healthy volunteers with no signs of liver diseasePatients with liver disease

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers:
  • males and females \>= 40 years (to be more like the anticipated age of the liver patients)
  • good peripheral blood vessels
  • written informed consent
  • Patients with liver cirrhosis:
  • known compensated liver cirrhosis with radiological or endoscopic signs of portal hypertension, such as varices, splenomegaly, or shunts.
  • written informed consent

You may not qualify if:

  • 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.
  • Circumstance that causes the responsible researcher to assess the research person's participation as inappropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 14186, Sweden

Location

Study Officials

  • Åke Norberg, PhD

    Karolinska Institutet, Stockholm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Åke Norberg, PhD

CONTACT

+46739669523ake.norberg@ki.se

Olav Rooyackers, Professor

CONTACT

+46739661645olav.rooyackers@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor, senior consultant

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

August 28, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations

SE(1)