Recruiting

Kinetic Biomarkers

Sponsor:

UCLA

Code:

NCT02124577

Conditions

Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a small preliminary study conducted to explore new methods for the potential of aiding in diagnosis of liver fibrotic disease as well as predicting disease progression. There will be a total of 4 visits spread out over approximately 8 weeks. You will be asked to drink "heavy water" during most of that time. "Heavy Water" also known as deuterated water, is physically and chemically very similar to ordinary drinking water. It tastes and feels exactly like regular water. It is odorless and has no known harmful effects at the doses given here. Heavy water occurs naturally, and is a minor component of the water we all ingest daily.

Conditions

Non-alcoholic Fatty Liver Disease

Study ID

NCT02124577

Start date

May, 2014

Status verified date

May, 2021

Completion date

May, 2021

Anticipated

Primary completion date

May, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults (≥ 18 years of age)
2. Adult male and female subjects, all races, ethnic groups, social and economic backgrounds and health status who are scheduled to undergo a liver biopsy as part of routine medical care will be included in the research.
3. Willingness to follow-up for 8 weeks
4. Written inform consent.

Exclusion Criteria:

1. Children younger than 18 will be excluded, since growth of liver tissue may confound measurements of collagen synthesis and cell proliferation due to normal turnover or disease.
2. The eligibility of patients will be determined by Dr. Rohit Loomba, MD or a referring physician at the time the potential subject is recommended to undergo a liver biopsy procedure as part of their medical treatment.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • evaluate stable isotope/mass spectrometric methods [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Leander A Lazaro

619-471-3915llazaro@ucsd.edu

Phirum Nguyen

619-471-0774psnguyen@ucsd.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92103

Contacts

Leander A Lazaro

619-471-3915

Phirum S. Nguyen

619-471-0774psnguyen@ucsd.edu

Principal Investigator:

Rohit Loomba, MD

More Information

Sponsor

University of California, San Diego

Last update posted

May 6, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2021-05-06.