Development of Kinetic Biomarkers of Liver Fibrosis Measuring NAFLD

NCT02124577 | Unknown

• 1 other identifier: 140338
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• evaluate stable isotope/mass spectrometric methods

  Our primary aim is to evaluate stable isotope/mass spectrometric methods for measuring in vivo liver collagen synthesis (fibrogenesis) and liver lipogenesis rates using liver biopsy specimens from patients with Non-Alcoholic Steatohepatitis (NASH)/ Nonalcoholic fatty liver disease (NAFLD).

  Baseline

Secondary Outcomes (1)

• serum or urine markers of liver fibrogenesis that can be measured by the same stable isotope/mass spectrometric approach

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults, age 18 or above, may have NAFLD or NASH-related cirrhosis or may serve as a control participant without this condition.

You may qualify if:

• Adults (≥ 18 years of age)
• 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.
• Willingness to follow-up for 8 weeks
• Written inform consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• KineMed: collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stored specimen The specimens (serum, plasma, urine, stool, saliva, liver tissue, and DNA) collected as part of this study will be kept in Dr. Loomba' s locked research freezer at the Clinical Teaching Facility (CTF-building A).All collected data and patient charts will be maintained at the CTF building in a locked computer file with access available to the principal and study investigators only. All samples and data will be labeled with a code number. The name, address, social security number, date of birth and other personal identifiers will not be available on the sample, and we will not give out any information that identifies the patient to the researchers who use these samples and data.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Rohit Loomba, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leander A Lazaro

CONTACT

619-471-3915; llazaro@ucsd.edu

Phirum Nguyen

CONTACT

619-471-0774; psnguyen@ucsd.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine, Division of Gastroenterology, Department of Medicine and

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

US (1)