Fatty LiverHPFFFNCT03480594
Effect of Fatty Liver on TCA Cycle Flux and the Pentose Phosphate Pathway
An observational study of Fatty Liver, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatty Liver
- What is being tested?
- MRI Tracer
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 13 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The plan is to study fatty liver patients and healthy subjects
Who may be able to join
- 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.
Who cannot join
- Fatty Liver Subjects
- No subjects taking hypoglycemic agents or insulin will be enrolled. There is no exclusion based on fasting glucose.
- Subjects with major mental health conditions such as schizophrenia and bipolar disorder that would limit compliance with study requirements will not participate. In general, subjects with any form of medical instability such as seizure disorders, significant COPD, significant asthma, left ventricular dysfunction will not participate.
- Medications for control of hypercholesterolemia, hypertriglyceridemia or hyperglycemia.
- Healthy Control Subjects
- Liver disease or other chronic illness
Show all 20Show fewer
- Diagnosis of type I or type II diabetes
- No subjects taking hypoglycemic agents or insulin will be enrolled. There is no exclusion based on fasting glucose.
- A potential subject with any major medical, surgical or psychiatric condition will not participate. These conditions include but are not limited to thyroid disease, chronic metabolic illness, known vascular disease, current cancer diagnosis and/or treatment.
- Subjects with major mental health conditions such as schizophrenia and bipolar disorder that would limit compliance with study requirements will not participate. In general, subjects with any form of medical instability such as seizure disorders, significant COPD, significant asthma, left ventricular dysfunction will not participate.
- Medications for control of hypercholesterolemia, hypertriglyceridemia or hyperglycemia.
- All Subjects
- No prior hepato-biliary surgery.
- Donated blood within the prior 4 weeks.
- Consume more than 10 grams of ethanol per day.
- Cirrhosis or any form of viral hepatitis.
- Prior documented hepatic reaction to drugs with a known hepatotoxicity profile such as isoniazid, methotrexate, phenytoin, propylthiouracil, valproate, etc.
- Pregnant/Lactating
- Receiving any other investigational agents.
- Any contraindication noted on the UTSWMC MRI Screening Form including implants contraindicated at 3T, pacemakers, Implantable Cardioverter Defibrillators (ICD), etc., and significant claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Imaging Research Center
Dallas, Texas, 75390-8568
About this study
Official title: Effect of Fatty Liver on TCA Cycle Flux and the Pentose Phosphate Pathway (HP FFF)
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.
Read the 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
- Being tested
- MRI Tracer
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI TracerDrug
Hyperpolarized [1-13C] pyruvate for injection under IND133229 used to enhance MRI/MRS/MRSI using a 3T MRI scanner.
| Study group | Role | What they receive |
|---|---|---|
| Fatty Liver Patients | Hyperpolarized [13C] Pyruvate Injection in Fatty Liver patients Receives: Drug: MRI Tracer | |
| Healthy Control Subjects | Hyperpolarized [13C] Pyruvate Injection in Healthy Control Subjects Receives: Drug: MRI Tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bicarbonate:lactate ratio
- 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.
Measured: One visit of 6 hours; two injections of HP pyruvate with MRI over 3 hours
Secondary outcomes (1)
Labeled glycerol fraction
- 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.
Measured: One visit of 6 hours; ingestion of Oral Glycerol with blood draws over 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Oct 2018
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Craig Riggs Malloy, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480594
- Sponsor's protocol ID
- 082017-019
- Other IDs
- 5P41EB015908-30
- Acronym
- HPFFF
- Status last verified
- Feb 2025
- First submitted
- 21 Mar 2018
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ardenkjaer-Larsen JH, Fridlund B, Gram A, Hansson G, Hansson L, Lerche MH, Servin R, Thaning M, Golman K. Increase in signal-to-noise ratio of > 10,000 times in liquid-state NMR. Proc Natl Acad Sci U S A. 2003 Sep 2;100(18):10158-63. doi: 10.1073/pnas.1733835100. Epub 2003 Aug 20.
PubMed 12930897Nelson SJ, Kurhanewicz J, Vigneron DB, Larson PE, Harzstark AL, Ferrone M, van Criekinge M, Chang JW, Bok R, Park I, Reed G, Carvajal L, Small EJ, Munster P, Weinberg VK, Ardenkjaer-Larsen JH, Chen AP, Hurd RE, Odegardstuen LI, Robb FJ, Tropp J, Murray JA. Metabolic imaging of patients with prostate cancer using hyperpolarized [1-(1)(3)C]pyruvate. Sci Transl Med. 2013 Aug 14;5(198):198ra108. doi: 10.1126/scitranslmed.3006070.
PubMed 23946197Cunningham CH, Lau JY, Chen AP, Geraghty BJ, Perks WJ, Roifman I, Wright GA, Connelly KA. Hyperpolarized 13C Metabolic MRI of the Human Heart: Initial Experience. Circ Res. 2016 Nov 11;119(11):1177-1182. doi: 10.1161/CIRCRESAHA.116.309769. Epub 2016 Sep 15.
PubMed 27635086Neeland IJ, Hughes C, Ayers CR, Malloy CR, Jin ES. Effects of visceral adiposity on glycerol pathways in gluconeogenesis. Metabolism. 2017 Feb;67:80-89. doi: 10.1016/j.metabol.2016.11.008. Epub 2016 Nov 27.
PubMed 28081781Neuschwander-Tetri BA, Caldwell SH. Nonalcoholic steatohepatitis: summary of an AASLD Single Topic Conference. Hepatology. 2003 May;37(5):1202-19. doi: 10.1053/jhep.2003.50193.
PubMed 12717402Satapati S, Kucejova B, Duarte JA, Fletcher JA, Reynolds L, Sunny NE, He T, Nair LA, Livingston KA, Fu X, Merritt ME, Sherry AD, Malloy CR, Shelton JM, Lambert J, Parks EJ, Corbin I, Magnuson MA, Browning JD, Burgess SC. Mitochondrial metabolism mediates oxidative stress and inflammation in fatty liver. J Clin Invest. 2015 Dec;125(12):4447-62. doi: 10.1172/JCI82204. Epub 2015 Nov 16.
PubMed 26571396Satapati S, Sunny NE, Kucejova B, Fu X, He TT, Mendez-Lucas A, Shelton JM, Perales JC, Browning JD, Burgess SC. Elevated TCA cycle function in the pathology of diet-induced hepatic insulin resistance and fatty liver. J Lipid Res. 2012 Jun;53(6):1080-92. doi: 10.1194/jlr.M023382. Epub 2012 Apr 9.
PubMed 22493093Sunny NE, Parks EJ, Browning JD, Burgess SC. Excessive hepatic mitochondrial TCA cycle and gluconeogenesis in humans with nonalcoholic fatty liver disease. Cell Metab. 2011 Dec 7;14(6):804-10. doi: 10.1016/j.cmet.2011.11.004.
PubMed 22152305Jones JG. Hepatic glucose and lipid metabolism. Diabetologia. 2016 Jun;59(6):1098-103. doi: 10.1007/s00125-016-3940-5. Epub 2016 Apr 5.
PubMed 27048250Jin ES, Moreno KX, Wang JX, Fidelino L, Merritt ME, Sherry AD, Malloy CR. Metabolism of hyperpolarized [1-(13)C]pyruvate through alternate pathways in rat liver. NMR Biomed. 2016 Apr;29(4):466-74. doi: 10.1002/nbm.3479. Epub 2016 Feb 2.
PubMed 26836042Jin ES, Sherry AD, Malloy CR. An Oral Load of [13C3]Glycerol and Blood NMR Analysis Detect Fatty Acid Esterification, Pentose Phosphate Pathway, and Glycerol Metabolism through the Tricarboxylic Acid Cycle in Human Liver. J Biol Chem. 2016 Sep 2;291(36):19031-41. doi: 10.1074/jbc.M116.742262. Epub 2016 Jul 18.
PubMed 27432878Jin ES, Sherry AD, Malloy CR. Interaction between the pentose phosphate pathway and gluconeogenesis from glycerol in the liver. J Biol Chem. 2014 Nov 21;289(47):32593-603. doi: 10.1074/jbc.M114.577692. Epub 2014 Oct 6.
PubMed 25288790Lee P, Leong W, Tan T, Lim M, Han W, Radda GK. In vivo hyperpolarized carbon-13 magnetic resonance spectroscopy reveals increased pyruvate carboxylase flux in an insulin-resistant mouse model. Hepatology. 2013 Feb;57(2):515-24. doi: 10.1002/hep.26028. Epub 2013 Jan 10.
PubMed 22911492Moreno KX, Moore CL, Burgess SC, Sherry AD, Malloy CR, Merritt ME. Production of hyperpolarized 13CO2 from [1-13C]pyruvate in perfused liver does reflect total anaplerosis but is not a reliable biomarker of glucose production. Metabolomics. 2015 Oct;11(5):1144-1156. doi: 10.1007/s11306-014-0768-1. Epub 2015 Jan 9.
PubMed 26543443Merritt ME, Harrison C, Sherry AD, Malloy CR, Burgess SC. Flux through hepatic pyruvate carboxylase and phosphoenolpyruvate carboxykinase detected by hyperpolarized 13C magnetic resonance. Proc Natl Acad Sci U S A. 2011 Nov 22;108(47):19084-9. doi: 10.1073/pnas.1111247108. Epub 2011 Nov 7.
PubMed 22065779
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fatty Liver on TCA Cycle Flux and the Pentose Phosphate Pathway (HP FFF)
- ClinicalTrials.gov ID
- NCT03480594
- Acronym / sponsor ID
- HPFFF / 082017-019
- Conditions
- Fatty Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatty Liver Patients | – | Drug: MRI TracerHyperpolarized [13C] Pyruvate Injection in Fatty Liver patients |
| Healthy Control Subjects | – | Drug: MRI TracerHyperpolarized [13C] Pyruvate Injection in Healthy Control Subjects |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The plan is to study fatty liver patients and healthy subjects
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- Fatty Liver Subjects
- No subjects taking hypoglycemic agents or insulin will be enrolled. There is no exclusion based on fasting glucose.
- Subjects with major mental health conditions such as schizophrenia and bipolar disorder that would limit compliance with study requirements will not participate. In general, subjects with any form of medical instability such as seizure disorders, significant COPD, significant asthma, left ventricular dysfunction will not participate.
- Medications for control of hypercholesterolemia, hypertriglyceridemia or hyperglycemia.
- Healthy Control Subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI TracerHyperpolarized [1-13C] pyruvate for injection under IND133229 used to enhance MRI/MRS/MRSI using a 3T MRI scanner. | Drug | Fatty Liver Patients, Healthy Control Subjects |
Primary outcome
Bicarbonate:lactate ratio
Time frame: 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.
1 secondary outcome
Labeled glycerol fraction
Time frame: One visit of 6 hours; ingestion of Oral Glycerol with blood draws over 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 12930897Ardenkjaer-Larsen JH, Fridlund B, Gram A, Hansson G, Hansson L, Lerche MH, Servin R, Thaning M, Golman K. Increase in signal-to-noise ratio of > 10,000 times in liquid-state NMR. Proc Natl Acad Sci U S A. 2003 Sep 2;100(18):10158-63. doi: 10.1073/pnas.1733835100. Epub 2003 Aug 20.
- Background: PubMed 23946197Nelson SJ, Kurhanewicz J, Vigneron DB, Larson PE, Harzstark AL, Ferrone M, van Criekinge M, Chang JW, Bok R, Park I, Reed G, Carvajal L, Small EJ, Munster P, Weinberg VK, Ardenkjaer-Larsen JH, Chen AP, Hurd RE, Odegardstuen LI, Robb FJ, Tropp J, Murray JA. Metabolic imaging of patients with prostate cancer using hyperpolarized [1-(1)(3)C]pyruvate. Sci Transl Med. 2013 Aug 14;5(198):198ra108. doi: 10.1126/scitranslmed.3006070.
- Background: PubMed 27635086Cunningham CH, Lau JY, Chen AP, Geraghty BJ, Perks WJ, Roifman I, Wright GA, Connelly KA. Hyperpolarized 13C Metabolic MRI of the Human Heart: Initial Experience. Circ Res. 2016 Nov 11;119(11):1177-1182. doi: 10.1161/CIRCRESAHA.116.309769. Epub 2016 Sep 15.
- Background: PubMed 28081781Neeland IJ, Hughes C, Ayers CR, Malloy CR, Jin ES. Effects of visceral adiposity on glycerol pathways in gluconeogenesis. Metabolism. 2017 Feb;67:80-89. doi: 10.1016/j.metabol.2016.11.008. Epub 2016 Nov 27.
- Background: PubMed 12717402Neuschwander-Tetri BA, Caldwell SH. Nonalcoholic steatohepatitis: summary of an AASLD Single Topic Conference. Hepatology. 2003 May;37(5):1202-19. doi: 10.1053/jhep.2003.50193.
- Background: PubMed 26571396Satapati S, Kucejova B, Duarte JA, Fletcher JA, Reynolds L, Sunny NE, He T, Nair LA, Livingston KA, Fu X, Merritt ME, Sherry AD, Malloy CR, Shelton JM, Lambert J, Parks EJ, Corbin I, Magnuson MA, Browning JD, Burgess SC. Mitochondrial metabolism mediates oxidative stress and inflammation in fatty liver. J Clin Invest. 2015 Dec;125(12):4447-62. doi: 10.1172/JCI82204. Epub 2015 Nov 16.
- Background: PubMed 22493093Satapati S, Sunny NE, Kucejova B, Fu X, He TT, Mendez-Lucas A, Shelton JM, Perales JC, Browning JD, Burgess SC. Elevated TCA cycle function in the pathology of diet-induced hepatic insulin resistance and fatty liver. J Lipid Res. 2012 Jun;53(6):1080-92. doi: 10.1194/jlr.M023382. Epub 2012 Apr 9.
- Background: PubMed 22152305Sunny NE, Parks EJ, Browning JD, Burgess SC. Excessive hepatic mitochondrial TCA cycle and gluconeogenesis in humans with nonalcoholic fatty liver disease. Cell Metab. 2011 Dec 7;14(6):804-10. doi: 10.1016/j.cmet.2011.11.004.
- Background: PubMed 27048250Jones JG. Hepatic glucose and lipid metabolism. Diabetologia. 2016 Jun;59(6):1098-103. doi: 10.1007/s00125-016-3940-5. Epub 2016 Apr 5.
- Background: PubMed 26836042Jin ES, Moreno KX, Wang JX, Fidelino L, Merritt ME, Sherry AD, Malloy CR. Metabolism of hyperpolarized [1-(13)C]pyruvate through alternate pathways in rat liver. NMR Biomed. 2016 Apr;29(4):466-74. doi: 10.1002/nbm.3479. Epub 2016 Feb 2.
- Background: PubMed 27432878Jin ES, Sherry AD, Malloy CR. An Oral Load of [13C3]Glycerol and Blood NMR Analysis Detect Fatty Acid Esterification, Pentose Phosphate Pathway, and Glycerol Metabolism through the Tricarboxylic Acid Cycle in Human Liver. J Biol Chem. 2016 Sep 2;291(36):19031-41. doi: 10.1074/jbc.M116.742262. Epub 2016 Jul 18.
- Background: PubMed 25288790Jin ES, Sherry AD, Malloy CR. Interaction between the pentose phosphate pathway and gluconeogenesis from glycerol in the liver. J Biol Chem. 2014 Nov 21;289(47):32593-603. doi: 10.1074/jbc.M114.577692. Epub 2014 Oct 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bicarbonate:lactate ratio (time frame: One visit of 6 hours; two injections of HP pyruvate with MRI over 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480594, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.