Assessment of Liver Metabolic Alterations in Vivo in Patients With Citrin Deficiency and Healthy Subjects by Metabolic Labeling With Stable Isotopes

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Citrin is an aspartate-glutamate transporter in the liver that facilitates the urea cycle pathway for ammonia detoxification via ureagenesis. It is also thought to be involved in liver energy metabolism as a component of the malate-aspartate shuttle. The clinical presentation in patients supports the hypothesis that liver glycolytic, gluconeogenic and lipogenic functions are compromised in citrin deficiency, but none of the key hepatic pathway fluxes have been measured in patients to date. This is the first study that will examine the liver metabolic fluxes in patients with citrin deficiency. Liver metabolic functions will be examined by metabolic flux assays and biochemical measurements after application of stable isotopes 2H2O and \[U-13C6\]-fructose. Urea cycle metabolites and their enrichment after application of a stable isotope tracer 15NH4Cl will be measured to examine the liver's ability to detoxify ammonia into urea.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• Subjects with citrin deficiency, confirmed by genetic analysis to carry pathogenic variant(s) in the SLC25A13 gene

• Age from 18 years to 65 years inclusive

• Male or female

• Written informed consent has been given

• Understands and is willing, able and likely to comply with study procedures and restrictions

• Age from 18 years to 65 years inclusive, and not more than five years younger or older than the specified paired participant from the AACD group

• Same sex as the specified paired participant from the AACD group

• Same ethnicity the specified paired participant from the AACD group

• Written informed consent has been given

• Understands and is willing, able and likely to comply with study procedures and restrictions

Locations
Other Locations
Switzerland
University Children's Hospital Zurich
RECRUITING
Zurich
Contact Information
Primary
Johannes Häberle, Prof. Dr. med.
Johannes.Haeberle@kispi.uzh.ch
+41 44 249 59 88
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2026-09
Participants
Target number of participants: 20
Treatments
Experimental: AACD patient
isotope tracer for ureagenesis and liver metabolic flux
Experimental: healthy volunteer
isotope tracer for ureagenesis and liver metabolic flux
Related Therapeutic Areas
Sponsors
Collaborators: Citrin Foundation, Marc Hellerstein, University of Berkeley
Leads: Johannes Haeberle

This content was sourced from clinicaltrials.gov

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