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.

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.

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

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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