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  • Book
  • © 2019

Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease

A Focus on Early Phase Clinical Drug Development

Editors:

  1. Andrew J. Krentz

    1. ProSciento, Chula Vista, USA

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    You can also search for this editor in PubMed   Google Scholar

  2. Christian Weyer

    1. ProSciento, Chula Vista, USA

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    You can also search for this editor in PubMed   Google Scholar

  3. Marcus Hompesch

    1. ProSciento, Chula Vista, USA

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    You can also search for this editor in PubMed   Google Scholar

  • Contains new chapters of how treatment can be applied for major disease areas

  • Provides a background to aid the understanding of drug effects and non-drug treatment strategies on key biochemical-hormonal defects of obesity and type 2 diabetes

  • Aids the selection of the most appropriate techniques for assessing insulin action, insulin secretion and body composition in humans?

  • Provides practical examples to assist usage/applications, explanation and study analysis

  • Perils and pitfalls are summarized for each technique

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Table of contents (20 chapters)

  1. Front Matter

    Pages i-xi
    PDF

  2. Review of Clinical Investigative Methods

    1. Front Matter

      Pages 1-1
      PDF

    2. Quantification of Insulin Action in Human Subjects

      • Andrew J. Krentz, Christian Weyer, Marcus Hompesch
      Pages 3-35

    3. Assessment of Islet Alpha- and Beta-Cell Function

      • Sten Madsbad, Jens J. Holst
      Pages 37-74

    4. Pharmacokinetic and Pharmacodynamic Assessment of Novel and Biosimilar Insulins

      • Andrew J. Krentz, Christian Weyer, Marcus Hompesch
      Pages 75-100

    5. Measurement of Energy Expenditure

      • Klaas R. Westerterp
      Pages 101-119

    6. Quantifying Appetite and Satiety

      • Catherine Gibbons, John E. Blundell
      Pages 121-140

    8. Structural and Functional Imaging of Muscle, Heart, Endocrine Pancreas and Kidneys in Cardiometabolic Drug Development

      • Olof Eriksson, Paul Hockings, Edvin Johansson, Lars Johansson, Joel Kullberg
      Pages 161-189

    10. Isotopic Tracers for the Measurement of Metabolic Flux Rates

      • Carine Beysen, Thomas E. Angel, Marc K. Hellerstein, Scott M. Turner
      Pages 211-243

    13. Omics: Potential Role in Early Phase Drug Development

      • Harald Grallert, Carola S. Marzi, Stefanie M. Hauck, Christian Gieger
      Pages 309-347

  3. Preclinical Drug Development and Transitioning to Clinical Studies

    1. Front Matter

      Pages 349-349
      PDF

    3. Animal Models of Type 2 Diabetes, Obesity and Nonalcoholic Steatohepatitis – Clinical Translatability and Applicability in Preclinical Drug Development

      • Henrik H. Hansen, Gitte Hansen, Thomas Secher, Michael Feigh, Sanne S. Veidal, Keld Fosgerau et al.
      Pages 369-403

    4. Drug Development for Diabetes Mellitus: Beyond Hemoglobin A1c

      • Fernando Bril, Marta Iruarrizaga-Lejarreta, Cristina Alonso
      Pages 405-421

    5. Emerging Circulating Biomarkers for The Diagnosis and Assessment of Treatment Responses in Patients with Hepatic Fat Accumulation, Nash and Liver Fibrosis

      • Marta Iruarrizaga-Lejarreta, Fernando Bril, Mazen Noureddin, Pablo Ortiz, Shelly C. Lu, José M. Mato et al.
      Pages 423-448

    6. Quantitative Approaches in Translational Cardiometabolic Research: An Overview

      • Farzaneh Maleki, Puneet Gaitonde, Shannon Miller, Mirjam N. Trame, Paul M. Coen, Parag Garhyan et al.
      Pages 449-466
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About this book

This book aims to aid the selection of the most appropriate methods for use in early phase (1 and 2) clinical studies of new drugs for diabetes, obesity, non-alcoholic fatty liver disease (NAFLD) and related cardiometabolic disorders.

Clinical research methods to assess the pharmacokinetics and pharmacodynamics of new diabetes drugs, e.g. the euglycemic clamp technique, have become well-established in proof-of-mechanism studies.  However, selection of the most appropriate techniques is by no means straightforward. Moreover, the application of such methods must conform to the regulatory requirements for new drugs.

This book discusses the need for new pharmacotherapies for diabetes, obesity and NAFLD and the molecular targets of drugs currently in development.  Emerging technologies including functional imaging, circulating biomarkers and omics are considered together with practical and ethical issues pertaining to early phase clinical trials in subjects with cardiometabolic disorders.

Translational Research Methods in Diabetes, Obesity, and Non-Alcoholic Fatty Liver Disease is of interest to biomedical scientists, pharmacologists, academics involved in metabolic research and clinicians practicing in these specialties.

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Keywords

  • obesity
  • diabetes
  • non-alcoholic fatty liver disease
  • glucose-lowering drugs
  • glucose clamp
  • insulin resistance
  • cardiometabolic disease
  • metabolic disease
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Editors and Affiliations

  • ProSciento, Chula Vista, USA

    Andrew J. Krentz, Christian Weyer, Marcus Hompesch

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About the editors

Andrew J Krentz, Senior Research Fellow at ProSciento, is a clinical academic with more than three decades of experience in diabetes and cardiometabolic medicine. He is currently a visiting professor at the University of Reading, UK. Prior to this he was a senior physician and senior lecturer at University Hospital Southampton, UK. He has held research positions at the University of California San Diego and the New Mexico School of Medicine, USA. He is editor-in-chief of ‘Cardiovascular Endocrinology & Metabolism’ and has published more than 100 articles in peer-reviewed medical journals.

Christian Weyer is a pharmaceutical executive with over 20 years of experience in the drug development focused on diabetes, obesity, and NAFLD/NASH.  As head of R&D at Amylin Pharmaceuticals and Intercept Pharmaceutics, he has contributed to the development, regulatory approval and/or life cycle management of several first-in-class medicines in the areas of type 1 and type 2 diabetes, lipodystrophy, and progressive non-viral liver diseases, as well as to the mid and late-stage development of novel drug candidates for obesity and NASH. Dr Weyer previously served as President and Chief Development Officer at ProSciento and as visiting fellow with the National Institutes of Health, NIDDK, and has authored over 100 peer-reviewed publications in the field of endocrinology and metabolism. 
 
Marcus Hompesch, Chief Executive Officer and Chairman of the Board, ProSciento is a recognized expert in the field of metabolic diseases, a licensed physician and entrepreneur. His experience in designing, performing and publishing clinical studies in metabolic diseases has been gained through over 20 years of work as clinician and clinical researcher. To date Dr Hompesch has authored more than 90 publications, has been editor and author of a textbook on translational research methods and is editor-in-chief of the journal ‘Endocrinology, Diabetes & Metabolism’. He established ProSciento, Inc., CA in 2003
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Bibliographic Information

  • Book Title: Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease

  • Book Subtitle: A Focus on Early Phase Clinical Drug Development

  • Editors: Andrew J. Krentz, Christian Weyer, Marcus Hompesch

  • DOI: https://doi.org/10.1007/978-3-030-11748-1

  • Publisher: Springer Cham

  • eBook Packages: Medicine, Medicine (R0)

  • Copyright Information: Springer Nature Switzerland AG 2019

  • Hardcover ISBN: 978-3-030-11747-4Published: 12 April 2019

  • eBook ISBN: 978-3-030-11748-1Published: 02 April 2019

  • Edition Number: 2

  • Number of Pages: XI, 556

  • Number of Illustrations: 56 b/w illustrations, 59 illustrations in colour

  • Topics: Diseases, Pharmacology

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Access via your institution
eBook USD 149.00
Price excludes VAT (USA)
  • ISBN: 978-3-030-11748-1
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Hardcover Book USD 179.99
Price excludes VAT (USA)
Learn about institutional subscriptions