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Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development. a Focus on Early Phase Clinical Studies
Smith, S. — Krentz, A. — Heinemann, L. — Hompesch, M.
1ª Edición Enero 2015
Inglés
Tapa dura
200 pags
500 gr
18 x 25 x null cm
ISBN 9781447149194
Editorial SPRINGER
ABOUT THIS BOOK
- 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
The world is beset by a pandemic of obesity and type 2 diabetes and the need
for new drugs is startlingly clear; recent years have seen a huge increase in
research activity to fill this gap. The development of new drugs for diabetes
and obesity must be founded upon a sound appreciation of the pathophysiology
of these common disorders. The dual defects of insulin resistance and impaired
insulin secretion are fundamental to the pathogenesis and progression of obesity-associated
type 2 diabetes. There is a need to explain how new drugs can counter insulin
resistance and insulin deficiency to a broad range of professionals, from clinical
scientists active in early (and later) phase drug development to specialist
physicians and increasingly primary care doctors who must tailor drug regimens
to the individual patient. Clinical research methods for measuring insulin action
and insulin secretion have become well-established in proof-of-mechanism studies;
however, selection of the best techniques is by no means straightforward. The
purpose of the book is to aid the selection of the most appropriate techniques
for assessing insulin action, insulin secretion and body composition in humans
(with particular reference to new drugs) in phase 1 and 2 studies and aid the
understanding of drug effects and non-drug treatment strategies on key biochemical-hormonal
defects of obesity and type 2 diabetes. The book will assume a working knowledge
of human physiology relating to glucose metabolism and will be of interest to
biomedical scientists, pharmacologists, academics involved in metabolic research
and clinicians practicing in these specialties.
Content Level » Professional/practitioner
Keywords » cardiometabolic - efficacy - glucose clamp - insulin resistance
- obesity - type 2 diabetes
Related subjects » Internal Medicine - Medicine - Pharmacology & Toxicology
TABLE OF CONTENTS
1. Review of physiology/pathophysiology.- 2. Methods for assessing insulin action in humans.- 3. Assessment of insulin secretion.- 4. Measurement of ectopic fat in liver and muscle using magnetic resonance spectroscopy.- 5. Isotopic tracers for the measurement of metabolic flux.- 6. Measuring food intake in clinical drug development.- 7. Measurement of energy expenditure.- 8. Assessment of body composition.- 9. Assessment of cardiovascular safety of new diabetes drugs.
AUTHORS & EDITORS
Andrew J Krentz, Senior Director of Scientific Services at the Profil Institute, is a clinical academic with more than three decades of experience in diabetes and cardiometabolic medicine. He holds a visiting chair at the Bedfordshire & Hertfordshire Postgraduate Medical School, University of Bedfordshire UK where he was Associate Professor before joining Profil. Prior to this he was a senior physician in internal medicine, diabetes & endocrinology at Southampton University Hospitals, UK. Lutz Heinemann, Senior Scientific Consultant at the Profil Institute, has acted as scientific advisor for Profil Institute since the company’s inception in 2004. He consults on the design of clinical trial protocols and in the publication of study results. He is also co-founder of Profil Institute for Metabolic Research in Neuss, Germany and led the company as CEO for 10 years until 2009. Prior to that, Prof. Dr. Heinemann spent 17 years performing diabetes-related clinical and experimental research at the Department of Metabolic Diseases and Nutrition, a World Health Organization Collaborating Center of Diabetes, at Heinrich-Heine University of Düsseldorf in Germany. Marcus Hompesch, President and Chief Executive Officer, Profil Institute, is an 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 18 years of work as clinician and clinical researcher. Dr. Hompesch established Profil Institute for Clinical Research in San Diego, CA in 2003.
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