De Novo Lipogenesis in Severity of NAFLD
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|ClinicalTrials.gov Identifier: NCT03683589|
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : March 13, 2019
|Condition or disease|
|Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Bariatric Surgery Candidate Obesity, Morbid|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Contribution of de Novo Lipogenesis in Severity of Nonalcoholic Fatty Liver Disease|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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 [ Time Frame: Dec 2019 ]DNL will be measured directly in the liver biopsies
- Histological scores (NAFLD activity score) [ Time Frame: Dec 2019 ]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.
- Liver enzymes [ Time Frame: Dec 2019 ]AST and ALT will be measured on the day when liver biopsy is collected
- FibroScan [ Time Frame: Dec 2019 ]Liver fat and fibrosis will also be measured non-invasively via FibroScan TM
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683589
|Contact: Majid Mufaqam Syed Abdul, MSemail@example.com|
|Contact: Elizabeht J Parks, PhDfirstname.lastname@example.org|
|United States, Missouri|
|University of Missouri||Recruiting|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Elizabeth J Parks, PhD||University of Missouri-Columbia|