Optimization of the intravenous glucose tolerance test in T2DM patients using optimal experimental design View Full Text


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Article Info

DATE

2009-06

AUTHORS

Hanna E. Silber, Joakim Nyberg, Andrew C. Hooker, Mats O. Karlsson

ABSTRACT

Intravenous glucose tolerance test (IVGTT) provocations are informative, but complex and laborious, for studying the glucose-insulin system. The objective of this study was to evaluate, through optimal design methodology, the possibilities of more informative and/or less laborious study design of the insulin modified IVGTT in type 2 diabetic patients. A previously developed model for glucose and insulin regulation was implemented in the optimal design software PopED 2.0. The following aspects of the study design of the insulin modified IVGTT were evaluated; (1) glucose dose, (2) insulin infusion, (3) combination of (1) and (2), (4) sampling times, (5) exclusion of labeled glucose. Constraints were incorporated to avoid prolonged hyper- and/or hypoglycemia and a reduced design was used to decrease run times. Design efficiency was calculated as a measure of the improvement with an optimal design compared to the basic design. The results showed that the design of the insulin modified IVGTT could be substantially improved by the use of an optimized design compared to the standard design and that it was possible to use a reduced number of samples. Optimization of sample times gave the largest improvement followed by insulin dose. The results further showed that it was possible to reduce the total sample time with only a minor loss in efficiency. Simulations confirmed the predictions from PopED. The predicted uncertainty of parameter estimates (CV) was low in all tested cases, despite the reduction in the number of samples/subject. The best design had a predicted average CV of parameter estimates of 19.5%. We conclude that improvement can be made to the design of the insulin modified IVGTT and that the most important design factor was the placement of sample times followed by the use of an optimal insulin dose. This paper illustrates how complex provocation experiments can be improved by sequential modeling and optimal design. More... »

PAGES

281

References to SciGraph publications

  • 2008-06. Approaches to handling pharmacodynamic baseline responses in JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
  • 2009-04. Simultaneous optimal experimental design on dose and sample times in JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
  • 2008-07. Pharmacokinetic/Pharmacodynamic Modelling in Diabetes Mellitus in CLINICAL PHARMACOKINETICS
  • 1998-12. Robust Optimal Design for the Estimation of Hyperparameters in Population Pharmacokinetics in JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
  • 2005-02. Robust Population Pharmacokinetic Experiment Design in JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s10928-009-9123-y

    DOI

    http://dx.doi.org/10.1007/s10928-009-9123-y

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1040901037

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/19554431


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