How healthy are the “Healthy volunteers”? Penetrance of NAFLD in the biomedical research volunteer pool

Varun Takyar, Anand Nath, Andrea Beri, Ahmed M. Gharib, Yaron Rotman – 3 May 2017 – Healthy volunteers are crucial for biomedical research. Inadvertent inclusion of subjects with nonalcoholic fatty liver disease (NAFLD) as controls can compromise study validity and subject safety. Given the rising prevalence of NAFLD in the general population, we sought to identify its prevalence and potential impact in volunteers for clinical trials. We conducted a cross‐sectional study of subjects who were classified as healthy volunteers between 2011 and 2015 and had no known liver disease.

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Neehar D. Parikh, Amit G. Singal, Anna S. Lok, Rajesh Balkrishnan, Vahakn Shahinian, Vincent D. Marshall – 3 May 2017

Acetyl‐coenzyme A carboxylase inhibition reduces de novo lipogenesis in overweight male subjects: A randomized, double‐blind, crossover study

Kathryn Stiede, Wenyan Miao, Heather S. Blanchette, Carine Beysen, Geraldine Harriman, H. James Harwood, Heather Kelley, Rosana Kapeller, Tess Schmalbach, William F. Westlin – 3 May 2017 – NDI‐010976, an allosteric inhibitor of acetyl‐coenzyme A carboxylases (ACC) ACC1 and ACC2, reduces hepatic de novo lipogenesis (DNL) and favorably affects steatosis, inflammation, and fibrosis in animal models of fatty liver disease.

How healthy are the “Healthy volunteers”? Penetrance of NAFLD in the biomedical research volunteer pool

Varun Takyar, Anand Nath, Andrea Beri, Ahmed M. Gharib, Yaron Rotman – 3 May 2017 – Healthy volunteers are crucial for biomedical research. Inadvertent inclusion of subjects with nonalcoholic fatty liver disease (NAFLD) as controls can compromise study validity and subject safety. Given the rising prevalence of NAFLD in the general population, we sought to identify its prevalence and potential impact in volunteers for clinical trials. We conducted a cross‐sectional study of subjects who were classified as healthy volunteers between 2011 and 2015 and had no known liver disease.

Alcohol abstinence ameliorates the dysregulated immune profiles in patients with alcoholic hepatitis: A prospective observational study

Wei Li, Tohti Amet, Yanyan Xing, Dennis Yang, Suthat Liangpunsakul, Puneet Puri, Patrick S. Kamath, Arun J. Sanyal, Vijay H. Shah, Barry P. Katz, Svetlana Radaeva, David W. Crabb, Naga Chalasani, Qigui Yu – 2 May 2017 – Alcoholic hepatitis (AH) develops in only a small proportion of heavy drinkers. To better understand the mechanisms underlying this disparity, we conducted a study to define the relationship between AH development and dysregulated immune responses that might be ameliorated by alcohol abstinence.

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