As recognition of fatty liver disease and non-alcoholic steatohepatitis (NASH) as a true global health crisis rises the need to collect, curate, and share relevant information in a timely fashion grows as well. The GLI NASH News is intended to meet that need and facilitate collaboration across the emerging NASH Community on a monthly basis.

We appreciate your feedback and content contributions. Please contact jhampton@globalliver.org

GLOBAL LIVER INSTITUTE

GLI Perspective

Fatty liver disease is estimated to affect up to 90% of people living with diabetes and up to 70% may have NASH[1]. Our colleagues in endocrinology are essential to successfully combating fatty liver disease and NASH.

A new study published in The Lancet Diabetes and Endocrinology found that diabetes may be considered as five different diseases instead of the traditional breakdown into Type 1 and Type 2 forms. The research suggests the potential for creating more personalized and tailored treatments for each form of the disease.

The research report identified the following patient clusters[2]:

Cluster 1 - severe autoimmune diabetes is broadly the same as the classical type 1 - it hit people when they were young, seemingly healthy and an immune disease left them unable to produce insulin

Cluster 2 - severe insulin-deficient diabetes patients initially looked very similar to those in cluster 1 - they were young, had a healthy weight and struggled to make insulin, but the immune system was not at fault

Cluster 3 - severe insulin-resistant diabetes patients were generally overweight and making insulin but their body was no longer responding to it

Cluster 4 - mild obesity-related diabetes was mainly seen in people who were very overweight but metabolically much closer to normal than those in cluster 3

Cluster 5 - mild age-related diabetes patients developed symptoms when they were significantly older than in other groups and their disease tended to be milder

We must continue to research how diabetes, the liver and other factors interact to cause NASH. Continuing efforts to better understand differences among those with diabetes is a step toward prevention and positive management of NASH.

Sources

[1] Information H, Disease L, NASH N et al. Definition & Facts of NAFLD & NASH | NIDDK. National Institute of Diabetes and Digestive and Kidney Diseases. 2018. Available at: https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts. Accessed March 13, 2018.

[2] Diabetes is 'five separate diseases'. BBC News. 2018. Available at: http://www.bbc.com/news/health-43246261. Accessed March 13, 2018.

NASH COUNCIL

New Members Spotlight!

University of Michigan NAFLD Clinic
Integritas Communications
Rush University

NASH Council Membership list

Want to be a member? Membership Application Form

Members have the benefit of accessing the secure NASH Council portal with workgroup meeting minutes, other members’ contact information, and will have the opportunity to participate in our full council meeting in June.

Workgroups

NASH Council workgroups are well underway. The purpose of the workgroups is to develop and execute plans to address specific aspects of the fatty liver disease epidemic. These workgroups are holding monthly calls. The workgroups are listed below with the meeting schedule and time.

Call to Action:

Workgroup presentations
Speakers Bureau
Invite others to join us

To RSVP for a workgroup, get the workgroup conference number, or get access to the NASH Council Portal please email NASH@globalliver.org

Public Education and Screening: First Thursday of every month. 12:00pm EDT
Clinician Education, Diagnosis, & Management: Second Thursday of every month. 12:00pm EDT (No April meeting due to participants attending EASL)
Patient Education and Support: Third Thursday of every month. 12:00pm EDT
Policy: Fourth Thursday of every month. 12:00pm EDT

The Liver Forum

The Liver Forum announce d on February 27, 2018, the “Early View” publication of its second manuscript, Case Definitions for Inclusion and Analysis of Endpoints in Clinical Trials for NASH through the Lens of Regulatory Science, published in the peer-reviewed journal Hepatology.

For more updates like this, follow @LiverForum on Twitter!

European Liver Patients’ Association (ELPA)

GLI CEO Donna R. Cryer, JD is honored to present an Update on the Global Liver Institute NASH Council to ELPA members on April 13, 2018 in Paris, France during the EASL meeting.

ELPA is now a member of EASL International Liver Foundation Scientific Research Group. In 2018 this group will launch the first NAFLD Policy Review in Europe. The first phase will include the NAFLD Policy Review in 6 countries in Europe and after will look to include other countries.

Additionally, ELPA recently announced participation in LIVERSCREEN, a project launched on February 26, 2018 and is supported by the European Institute for Innovation and Technology. LIVERSCREEN will begin with early detection of liver diseases in Barcelona, Spain and Paris, France. In the next phases, the project will include several countries and screen 20,000 people in Europe with FibroScan. The project is projected to be the most significant screening for early detection of liver diseases ever conducted. ELPA is responsible for project dissemination and communication.

Fatty Liver Foundation

The Fatty Liver Foundation recently surveyed 112 patients, gathering the age in which they were first diagnosed with NASH. As shown below, more than one-third of the patients were first diagnosed before the age of 50.

Industry

TARGET PharmaSolutions, Inc.

TARGET PharmaSolutions is a data solutions company that provides pharmaceutical and biotechnology partners a more efficient way to generate data in the real-world setting. TARGET PharmaSolutions has announced it’s long-term strategic alliance for TARGET-NASH which originally launched August 2016. TARGET-NASH is a longitudinal observational study that evaluates adults and pediatric patients with NAFLD or NASH. The academic steering committee is chaired by Dr. Arun Sanyal, Dr. Ken Cusi, and Dr. Brent Tetri.

The Global NASH Market

A commercial report on global and regional markets has found that the global NASH market is expected to exceed US $20 Billion by 2025. The scope of the report includes a detailed study of global and regional markets for various types of NASH. The full report is available for purchase and covers a competitive outlook including the market share and company profiles of the key participants operating in the global market.

Regulatory

USDA - Dietary Guidelines

The USDA and HHS are in the process of developing the 2020-2025 Dietary Guidelines for Americans. For the first time, the departments are seeking public comments on the proposed topics and supporting scientific questions based on relevance, importance, potential federal impact, and avoiding duplication. The comment period is open until March 30, 2018. First review the topics and scientific questions and then view public comments or comment yourself here. Also, please send a copy of the comments to us at nash@globalliver.org

Clinical Trials

150 clinical trials globally recruiting for NAFLD
52 clinical trials globally recruiting for NASH

Grant Opportunities

Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (R21 Clinical Trial Optional). Funds Available from NIH: $200,000. Application deadlines: March 16, 2018, July 16, 2018, or November, 2018

Research

LiverMultiScan

A study jointly led by the UK’s University of Birmingham and University of Edinburgh has revealed that a new scanning technology could almost halve the number of liver biopsies carried out on people with fatty liver disease. LiverMultiScan can be used to help doctors diagnose liver disease at all stages and help predict whose liver disease will progress more quickly. Read the full article on the study here.