Clinical Trials Logo

Clinical Trial Summary

The researchers will recruit patients with liver disease at Parkland Hospital. Patients will fast overnight, and the next morning will receive an oral mixture of [U-13C3]glycerol (25 mg/kg) plus unlabeled glycerol (25 mg/kg). The total dose of glycerol will be 50 mg/kg in 100 milliliters of water. The taste is slightly sweet. Blood will be drawn at 60 min and 120 min after the ingestion. Blood glucose will be isolated and analyzed by NMR. The presence of [5,6-13C2]- and [4,5-13C2]glucose indicates preserved mitochondrial function. The researchers anticipate that patients with severe liver disease will show a decrease in mitochondrial function and will inform biosynthetic function of liver mitochondria. After the first 6 successful exams (see power analysis, below), healthy volunteers (age-, gender-, and race-matched) will be studied at the AIRC and subject to the same protocol.


Clinical Trial Description

The researchers will recruit patients with severe liver disease at Parkland Hospital where the procedure will be performed. Age-, gender- and race-matched healthy subjects will be recruited from general population, and the procedure will be performed at the procedure room of the AIRC. Patients at Parkland will be screened and selected by Dr. Jeffrey Browning and Dr. Rodney Infante. After ingestion of 25 mg/kg [U-13C3]glycerol plus 25 mg/kg unlabeled glycerol in water (total glycerol dose, 50 mg/kg), blood will be drawn at +60 and +120 min. Healthy subjects will make two visits to the AIRC for screening and study procedures. The screening visit will take an hour and the study visit will take 3 hours. Volunteers will be made comfortable in the procedure room of the Research Center. All the study procedures at both Parkland and AIRC will be under the direction of the principal investigator, Dr. Jeffrey Browning. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02457702
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Terminated
Phase N/A
Start date October 2015
Completion date December 2021

See also
  Status Clinical Trial Phase
Completed NCT04097704 - Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
Completed NCT02161224 - A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function Phase 1
Completed NCT00929032 - Liver Transplantation and Reticuloendothelial Clearance Capacity N/A
Completed NCT00509210 - Study of Telaprevir in Subjects With Hepatic Impairment Phase 1
Completed NCT02894385 - Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201) Phase 1
Completed NCT03306667 - Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency) Phase 1
Not yet recruiting NCT05093972 - Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014) Phase 1
Completed NCT04867941 - A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196 Phase 1
Completed NCT02090621 - Extracorporeal Photopheresis After Liver Transplant Phase 2
Completed NCT02249442 - Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency Phase 1
Completed NCT03341884 - A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants Phase 1
Completed NCT01475136 - A Study of LY2140023 in Hepatically-Impaired Participants Phase 1
Completed NCT00968591 - Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency Phase 1
Completed NCT00969813 - A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function Phase 1
Completed NCT00931060 - Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects N/A
Completed NCT00416702 - Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function Phase 1
Completed NCT03968848 - Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite Phase 1
Recruiting NCT05209295 - A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies Phase 1
Completed NCT00692341 - Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics Phase 1
Completed NCT00314054 - Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults Phase 1