NCT03480594

Effect of Fatty Liver on TCA Cycle Flux and the Pentose Phosphate Pathway

Effect of Fatty Liver on TCA Cycle Flux and the Pentose Phosphate Pathway (HP FFF)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The investigators plan to evaluate sensitivity and specificity of HP 13C-pyruvate as an imaging agent for detection of altered PDH flux in fatty liver.

Detailed description

The investigators plan to determine whether nutritional state and fatty liver influence the production of \[13C\]bicarbonate from \[1-13C\]pyruvate via flux through the pyruvate dehydrogenase (PDH) reaction in healthy subjects compared to those with fatty liver. The long-term purpose of this work is to develop hyperpolarized 13C imaging as a method to directly assess metabolic pathways in the human liver. Many high-impact diseases such as insulin resistant states, fatty liver and inborn errors of metabolism are known to alter biochemical fluxes and for this reason it is important to detect altered activity in specific pathways.

Conditions

• Fatty Liver

Interventions

Type	Name	Description
DRUG	MRI Tracer	Hyperpolarized \[1-13C\] pyruvate for injection under IND133229 used to enhance MRI/MRS/MRSI using a 3T MRI scanner.

Timeline

• Start date: 2018-10-01
• Primary completion: 2023-10-13
• Completion: 2023-10-13
• First posted: 2018-03-29
• Last updated: 2025-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study