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Trial record 11 of 65 for:    Taste Disorders | NIH

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 : March 22, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Hepatic Insufficiency Hypoalbuminemia Other: Orally administered labeled glycerol Not Applicable

Detailed 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 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 : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457702


Contacts
Contact: Jeannie Baxter, RN 214-645-2726 jeannie.baxter@utsouthwestern.edu
Contact: Lucy H Christie, RN 214-648-2215 lucy.christie@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center - Advanced Imaging Research Center Recruiting
Dallas, Texas, United States, 75390
Contact: Jeannie Baxter, RN    214-645-2726    jeannie.baxter@utsouthwestern.edu   
Principal Investigator: Jeffrey Browning, MD         
Sub-Investigator: Eunsook Jin, PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02457702     History of Changes
Other Study ID Numbers: STU 022015-085
R01DK099289 ( U.S. NIH Grant/Contract )
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Blood Protein Disorders
Hematologic Diseases
Hepatic Insufficiency
Hypoalbuminemia
Hypoproteinemia
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs