Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT03480594
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fatty Liver on TCA Cycle Flux and the Pentose Phosphate Pathway
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Effect of Fatty Liver on TCA Cycle Flux and the Pentose Phosphate Pathway (HP FFF)
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPFFF
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P41EB015908-30 | NIH | None | https://reporter.nih.gov/quic… | View |