Mitochondrial Function in Patients With Severe Liver Disease (SLDglyc)
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|ClinicalTrials.gov Identifier: NCT02457702|
Recruitment Status : Recruiting
First Posted : May 29, 2015
Last Update Posted : April 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Insufficiency Hypoalbuminemia||Other: Orally administered labeled glycerol||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Mitochondrial Function in Patients With Severe Liver Disease|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Orally administered Labeled Glycerol
Patients 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.
Other: Orally administered labeled glycerol
Oral administration of labeled glycerol
- Detection of 13C in plasma glucose by NMR of a blood sample [ Time Frame: At 60 minutes and 120 minutes post ingestion ]Once at 60 minutes post ingestion and once at 120 minutes ingestion for a total ot 2 times
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457702
|Contact: Jeannie Baxter, RNemail@example.com|
|Contact: Lucy H Christie, RNfirstname.lastname@example.org|
|United States, Texas|
|UT Southwestern Medical Center - Advanced Imaging Research Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Jeannie Baxter, RN 214-645-2726 email@example.com|
|Principal Investigator: Jeffrey Browning, MD|
|Sub-Investigator: Eunsook Jin, PhD|