Mitochondrial Function in Patients With Severe Liver Disease

NCT02457702 | Terminated

• 2 other identifiers: STU 022015-085R01DK099289
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Insufficiency; Hypoalbuminemia

Outcome Measures

Primary Outcomes (1)

• Detection of 13C in plasma glucose by NMR of a blood sample

  Once at 60 minutes post ingestion and once at 120 minutes ingestion for a total ot 2 times

  At 60 minutes and 120 minutes post ingestion

Study Arms (1)

Orally administered Labeled Glycerol

EXPERIMENTAL

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

Interventions

Orally administered labeled glycerol OTHER

Oral administration of labeled glycerol

Orally administered Labeled Glycerol

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UT Southwestern Medical Center - Advanced Imaging Research Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hepatic Insufficiency; Hypoalbuminemia

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR & CHAIR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 29, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)