Translational Research Methods for the Metabolic Continuum
Description
In this 3 rd edition, we position metabolic fatty liver disease (MAFLD) more prominently both as a component and driver of a metabolic continuum of non-communicable disorders. These include obesity, diabetes, cardiovascular, and renal disease. All share common risk factors and are interconnected via complex - and often bidirectional - pathological processes.
The pivotal position of MAFLD reflects increasing awareness in recent years of (a) intersections between metabolic liver disease and the broader spectrum of cardiometabolic disorders and (b) the unmet need for effective new pharmacotherapies.
Evidence from clinical trials of medications originally developed to treat obesity and diabetes points to the need for practical non-invasive methods for quantifying therapeutic effects on hepatic steatosis. An intense drug development effort continues aimed at the clinically important subtype of non-alcoholic steatohepatitis (NASH) which carriesan increased risk of fibrosis, cirrhosis, and hepatocellular carcinoma. Moreover, MAFLD/NASH is recognized as a multisystem disease with myriad extrahepatic manifestations. The 3 rd edition will update all chapters with particular emphasis on expanding the chapters on hepato-cardio-renal and functional imaging; the chapter on isotopic tracer methodology will also be strengthened. Relevant new chapters in a new section will address the future prospects for biomarkers to include proteomics, metabolomics, and genomics. The potential of computational modeling in translational research will be covered alongside the value of real-world data in drug development and strategies for personalized precision management of diseases in the metabolic continuum.The book will continue our objective - established in the earlier editions - to remain at the forefront of clinical science that facilitates paradigm changes and provides leadership in translational research for cardiometabolic disorders.
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Persons
Andrew J. Krentz M.D . - Andrew holds the position of Senior Research Fellow at ProSciento, Inc. His experience as a researcher - gained in the UK and USA - has ranged from human metabolism to epidemiology to preclinical and early-phase clinical cardiometabolic drug development. His M.D. research thesis was titled Metabolic Studies in Insulin Resistance. His professional accolades include honorary Fellowship of the Faculty of Pharmaceutical Medicine (FFPM) of the Royal College of Physicians of London in recognition of 'outstanding contributions to pharmaceutical medicine' and Fellowship of the Royal College of Pathologists (FRCPath) on the strength of his publications in the field of chemical pathology-clinical biochemistry. He is recognised as a clinical specialist by the European Society of Hypertension. He serves on the Medical, Scientific & Research Committee of HEART UK and is President of Vascular, Lipid & Metabolic Medicine at the Royal Society of Medicine, London, UK.
Professor Krentz has held senior positions within the NHS, academia, and the life sciences. He currently holds visiting chairs in the School of Population Health Sciences at King's College London and at the Institute of Cardiovascular & Metabolic Research at the University of Reading, UK. His recent textbooks include: Krentz A.J., Weyer C., Hompesch M. (Eds) Translational Research Methods in Diabetes, Obesity and Nonalcoholic Fatty Liver Disease: Focus on Early Phase Clinical Drug Development. Springer 2019 ; Krentz A.J. & Chilton R. (eds). Cardiovascular Endocrinology & Metabolism: Theory & Practice of Cardiometabolic Medicine. Academic Press, 2023 In press; Krentz A.J. (Ed). Insulin@100: Deficiency, Excess & Resistance in Human Disease. Academic Press, 2023 in press . Professor Krentz is the founding editor-in-chief of the interdisciplinary scientific journal Cardiovascular Endocrinology & Metabolism (www.cardiovascularendocrinology.com).
Marcus Hompesch M.D. - Dr. Marcus Hompesch is Chief Executive Officer and Chairman of the Board of ProSciento and has led the company since its inception in 2003. He is also editor-in-chief of the journal Endocrinology, Diabetes & Metabolism, a Wiley publication. His career and track record in metabolism-focused clinical R&D, spanning more than 25 years in academic and industry settings, includes contributions to clinical development strategies and early phase research studies for many of the diabetes and related metabolic drugs and devices on the market globally. Prior to leading ProSciento, Dr. Hompesch was Chief Operating Officer of Profil Institut für Stoffwechselforschung GmbH and, before that, was founder and Chief Executive Officer of the medical technology company Med.IQ. He is an author of more than 100 publications, including peer-reviewed journals and editorials and is a regular peer reviewer for scientific journals relevant to metabolic diseases. He is also an editor and co-author of the textbook Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development. As a licensed physician in Europe he received his M.D. from the University of Düsseldorf, Germany, and following medical school trained in internal medicine and diabetology at the Klinikum Wuppertal Medical Center. He also was a scientific associate at the Department of Medical Informatics, Bio-Statistics and Epidemiology at the Ruhr University Bochum, Germany.
Content
1 Metabolic Continuum: A Conceptual Pathogenic Framework.- 2 Quantification of Insulin Action in Human Subjects.- 3 Assessment of Islet Alpha- and Beta-Cell Function in Humans.- 4 Pharmacokinetic and Pharmacodynamic Assessment of Novel and Biosimilar Insulins.- 5 Measurement of Energy Expenditure.- 6 Quantifying Appetite and Satiety.- 7 Non-invasive Quantitative Magnetic Resonance- and Ultrasound-based Biomarkers in Metabolic Dysfunction-associated Steatotic Liver Disease and Other Cardiometabolic Diseases Associated with Ectopic Fat Deposition.- 8 Structural and Functional Imaging of Muscle, Heart, Endocrine Pancreas and Kidneys in Drug Development for the Metabolic Continuum.- 9 Isotopic Tracers for the Measurement of Metabolic Flux Rates.- 10 Role of Tissue Biopsy in Drug Development for Metabolic Dysfunction-Associated Steatotic Liver Disease and Other Metabolic Disorders.- 11 Utility of Invasive and Non-invasive Cardiovascular Research Methodologies in Drug Development for The Metabolic Continuum.- 12 Omics: Potential Role in Early-Phase Drug Development for Obesity and Type 2 Diabetes.- 13 Early Phase Metabolic Research with Reference to Special Populations.- PART 2 Preclinical Drug Development and Transitioning to Clinical Studies.- 14 Sculpting the Metabolic Continuum - Translational Aspects.- 15 Animal Models of Type 2 Diabetes, Obesity And Metabolic Dysfunction-Associated Steatohepatitis - Clinical Translatability And Applicability In Preclinical Drug Development.- 16 Quantitative Approaches in Translational Cardiometabolic Research: An Overview.- 17 Regulatory Considerations for Early Study and Clinical Development of Drugs for Diabetes, Obesity, Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) and other Disorders in the Metabolic Continuum.- PART 3 Emerging Translational Research Methods and Real-World Therapeutic Considerations.- 18 Emerging Future Prospects for Translational Cardiometabolic Research: Real World Data to Inform Drug Development for the Metabolic Continuum.- 19 "Towards Precision Diagnosis and Management for the Metabolic Continuum: How Artificial Intelligence and Data Science are Revolutionizing Translational Medicine and Clinical Care.- 20 GLP-1 receptor agonists: role in the prevention and treatment of diabetes-related cardiovascular complications.