Mitochondrial Function in Patients With Severe Liver Disease (NCT02457702) | Clinical Trial Compass
TerminatedNot Applicable
Mitochondrial Function in Patients With Severe Liver Disease
Stopped: Unable to recruit. Only 2 subjects completed.
United States2 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Detection of 13C in plasma glucose by NMR of a blood sample
Timeframe: At 60 minutes and 120 minutes post ingestion
Trial details
NCT IDNCT02457702
SponsorUniversity of Texas Southwestern Medical Center