Fatty Liver
Conditions
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.
Interventions
DRUGMRI Tracer
Hyperpolarized \[1-13C\] pyruvate for injection under IND133229 used to enhance MRI/MRS/MRSI using a 3T MRI scanner.
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
University of Texas Southwestern Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18 to 99 years. * All races, ethnicities and gender identification may be included. Subjects must meet all of the inclusion and
Exclusion criteria
to be included in the study. * Either fatty liver diagnosis (defined as \>5.6% fat content in the liver) or healthy control * While all races and ethnicities will be included, subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included. * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bicarbonate:lactate ratio | One visit of 6 hours; two injections of HP pyruvate with MRI over 3 hours | 1\. The ratio of hyperpolarized \[13C\]bicarbonate relative to hyperpolarized \[1-13C\]lactate. This measurement will be monitored from the subject's liver over a \ 4 minute period in the MRI system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Labeled glycerol fraction | One visit of 6 hours; ingestion of Oral Glycerol with blood draws over 3 hours | 2\. The fraction of \[U-13C\]glycerol that has passed through mitochondrial pathways prior to gluconeogenesis and the fraction of glucose, derived from \[U-13C\]glycerol, that has passed through the pentose phosphate pathway. This information will be acquired from 13C NMR spectroscopy of glucose and triglycerides from a venous blood sample, obtained after the hyperpolarization exam. |
Countries
United States
Outcome results
None listed