Mitochondrial Function in Patients With Severe Liver Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 4/3/2019 |
| Start Date: | October 2015 |
| End Date: | December 2021 |
| Contact: | Jeannie Baxter, RN |
| Email: | jeannie.baxter@utsouthwestern.edu |
| Phone: | 214-645-2726 |
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.
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.
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.
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.
Inclusion Criteria:
- Severe liver disease defined as known liver disease plus at least one of the
following: serum albumin less than 3.0 g/dL or INR more than 2.0.
Exclusion Criteria:
- Portal systemic encephalopathy
- Pregnancy or breastfeeding.
- Anemia (hematocrit < 32%)
- Significant weight loss or use of diet pills within previous 6 months.
- Cannot give informed consent, understand the protocol, or tolerate any aspect of the
protocol.
We found this trial at
1
site
Dallas, Texas 75390
Principal Investigator: Jeffrey Browning, MD
Phone: 214-645-2726
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