NCT03683589|Completed
De Novo Lipogenesis in Severity of NAFLD
Contribution of De Novo Lipogenesis in Severity of Nonalcoholic Fatty Liver Disease
Loading search results
Contribution of De Novo Lipogenesis in Severity of Nonalcoholic Fatty Liver Disease
Sponsor study identifier
Secondary identifiers
NIH
observational
49
1 country
1
Study Start
February 1, 2019
Actual (reported)Primary Completion
August 21, 2019
Actual (reported)Study Completion
July 31, 2020
Actual (reported)NAFLD is the most prevalent liver disease in the U.S., and there is a serious need to understand its progression to the advanced state, nonalcoholic steatohepatitis (NASH). Previous studies has shown that elevated de novo lipogenesis (DNL) is the unique, early event distinguishing patients with NAFLD from equally-obese subjects with low IHTG. The purpose of this study is to directly by measure DNL in human liver tissue and comparing it to liver histological scores from patient biopsies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2018
Actual (reported)September 25, 2018
Actual (reported)February 1, 2019
Actual (reported)August 21, 2019
Actual (reported)July 31, 2020
Actual (reported)De novo lipogenesis
DNL will be measured directly in the liver biopsies
Dec 2019
Histological scores (NAFLD activity score)
Dec 2019
Liver enzymes
Dec 2019
FibroScan
Dec 2019
Participants will receive deuterated water for 10 days before undergoing bariatric surgery. Liver biopsy collected, lipids extracted and DNL measured via GC/MS.
The study includes both obese men and women who are undergoing bariatric surgery
University of Missouri
Columbia, Missouri, 65212, United States
Lambert JE, Ramos-Roman MA, Browning JD, Parks EJ. Increased de novo lipogenesis is a distinct characteristic of individuals with nonalcoholic fatty liver disease. Gastroenterology. 2014 Mar;146(3):726-35. doi: 10.1053/j.gastro.2013.11.049. Epub 2013 Dec 4.
Donnelly KL, Smith CI, Schwarzenberg SJ, Jessurun J, Boldt MD, Parks EJ. Sources of fatty acids stored in liver and secreted via lipoproteins in patients with nonalcoholic fatty liver disease. J Clin Invest. 2005 May;115(5):1343-51. doi: 10.1172/JCI23621.
Plasma samples will be stored in a -80C freezer. Liver samples will be tested immediately and will not be stored.
Elizabeth J Parks, PhD
University of Missouri-Columbia
49 participants (actual enrollment reported by the registry).
First Submitted
September 20, 2018
First Posted
September 25, 2018
Study Start
February 1, 2019
Actual (reported)The Liver Health Study for Patients with NAFLD
Contact the study team to confirm eligibility.
Syed-Abdul MM, Moore MP, Wheeler AA, Ganga RR, Diaz-Arias A, Petroski GF, Rector RS, Ibdah JA, Parks EJ. Isotope Labeling and Biochemical Assessment of Liver-Triacylglycerol in Patients with Different Levels of Histologically-Graded Liver Disease. J Nutr. 2023 Dec;153(12):3418-3429. doi: 10.1016/j.tjnut.2023.09.018. Epub 2023 Sep 27.
Primary Completion
August 21, 2019
Actual (reported)Study Completion
July 31, 2020
Actual (reported)Last Updated
December 19, 2024
Record last verified: 2020-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: