An observational study in Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis and Bariatric Surgery Candidate, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by University of Missouri-Columbia · Observational
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.
The development of nonalcoholic fatty liver disease (NAFLD) progresses from a state of elevated intrahepatic triglycerides (IHTG) to liver inflammation, and ultimately, hepatic apoptosis and fibrosis. 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). Elevated de novo lipogenesis (DNL) is the unique, early event distinguishing patients with NAFLD from equally-obese participants with low IHTG. DNL is the process of liver synthesis of fatty acids (FAs) from carbohydrate. In humans, studies have shown that DNL significantly predicts the magnitude of IHTG, however, it is unknown whether the pathway plays a role in disease progression. Evidence supporting this concept includes the fact that the primary product of DNL is the saturated FA, palmitate, which in cell culture has been shown to significantly contribute to oxidative stress and inflammation. Recent rodent data show that upregulation of DNL through dietary supplementation of sucrose exacerbated the hepatotoxic effects of excess dietary FAs. A preliminary abstract presented by others at the 2017 Liver Meeting suggested that DNL may not be different between patients with low and high liver fibrosis, although these data were collected using an indirect measure of liver disease. Here, in the present study, the hypothesis will be tested directly by measuring DNL in human liver tissue and comparing it to liver histological scores (NAFLD Activity Score, NAS) from patient samples.
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This study's enrollment of 49 is below the median of 167 across 681 observational studies indexed under Liver Diseases.
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The study includes both obese men and women who are undergoing bariatric surgery
Inclusion and exclusion criteria are similar to the criteria set by a larger project (NCT03151798).
Inclusion criteria:
Exclusion criteria:
Participants will receive deuterated water for 10 days before undergoing bariatric surgery. Liver biopsy collected, lipids extracted and DNL measured via GC/MS.
De novo lipogenesis
DNL will be measured directly in the liver biopsies
Time frame: Dec 2019
Histological scores (NAFLD activity score)
Tissue histology will be performed to obtain NAFLD activity score (NAS). A pathologist, trained in determining the NAS of histological samples, grades them for the quantity of fat present, and the levels of inflammation and fibrosis. A score of 0 is considered completely healthy (devoid of any of these three characteristics), while a score of 8 indicates severe pathology, advanced as far as cirrhosis.
Time frame: Dec 2019
Liver enzymes
AST and ALT will be measured on the day when liver biopsy is collected
Time frame: Dec 2019
FibroScan
Liver fat and fibrosis will also be measured non-invasively via FibroScan TM
Time frame: Dec 2019
Plan to share: Undecided
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University of Missouri-Columbia