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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
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

Tracking Information
First Submitted Date  ICMJE April 30, 2015
First Posted Date  ICMJE May 29, 2015
Last Update Posted Date April 1, 2019
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02457702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mitochondrial Function in Patients With Severe Liver Disease
Official Title  ICMJE Mitochondrial Function in Patients With Severe Liver Disease
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hepatic Insufficiency
  • Hypoalbuminemia
Intervention  ICMJE Other: Orally administered labeled glycerol
Oral administration of labeled glycerol
Study Arms  ICMJE 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.
Intervention: Other: Orally administered labeled glycerol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 26, 2015)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jeannie Baxter, RN 214-645-2726 jeannie.baxter@utsouthwestern.edu
Contact: Lucy H Christie, RN 214-648-2215 lucy.christie@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02457702
Other Study ID Numbers  ICMJE STU 022015-085
R01DK099289 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account University of Texas Southwestern Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP