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Lipoproteins in Diabetes Mellitus pp 329–346Cite as

About Randomised Clinical Trials Related to Lipoproteins in Diabetes Mellitus

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Part of the book series: Contemporary Diabetes ((CDI))

Abstract

The results of randomised controlled clinical trials in humans provide robust evidence to guide clinical practice. Such trials related to the treatment of lipoprotein levels in people with diabetes mellitus have contributed to clinical practice guidelines and to the improved clinical outcomes observed in recent years. Randomised controlled trials (RCTs) are often suggested and informed by epidemiology, cross-sectional studies and preclinical studies, and their results can also guide novel basic science research. RCTs are major undertakings in effort, time and cost; hence their careful design, conduct and interpretation are important. Terms such as the phases of clinical research, types of statistical errors and Hawthorne effect are defined. Important study design issues such as subject selection, sample size and randomisation, the choice of study end points and the potential confounding effects of metabolic memory and drug pleiotropic effects are also considered. References to major sources of further information are also provided in this chapter.

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Acknowledgements

The Clinical Trials Centre is partly supported by funding from the Australian National Health and Medical Research Council.

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Authors and Affiliations

  1. NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia

    Anthony Keech, Alicia J. Jenkins M.D., F.R.A.C.P. & Val Gebski

  2. Section of Endocrinology and Diabetes, University of Oklahoma Health Sciences Center, 941 Stanton L. Young Blvd., BSEB 302F, Oklahoma City, OK, 73104, USA

    Alicia J. Jenkins M.D., F.R.A.C.P.

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  1. Anthony Keech
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  2. Alicia J. Jenkins M.D., F.R.A.C.P.
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  3. Val Gebski
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Correspondence to Alicia J. Jenkins M.D., F.R.A.C.P. .

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Editors and Affiliations

  1. NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia

    Alicia J. Jenkins

  2. College of Medicine, University of Illinois, Peoria, Illinois, USA

    Peter P. Toth

  3. Section of Endocrinology and Diabetes Harold Hamm Diabetes Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA

    Timothy J. Lyons

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Keech, A., Jenkins, A.J., Gebski, V. (2014). About Randomised Clinical Trials Related to Lipoproteins in Diabetes Mellitus. In: Jenkins, A., Toth, P., Lyons, T. (eds) Lipoproteins in Diabetes Mellitus. Contemporary Diabetes. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4614-7554-5_17

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