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Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children.

Publication ,  Journal Article
Green, TP; Binns, HJ; Wu, H; Ariza, AJ; Perrin, EM; Quadri, M; Hornik, CP; Cohen-Wolkowiez, M
Published in: Clin Transl Sci
March 2021

Obesity is a prevalent childhood condition and the degree of adiposity appears likely to be an important covariate in the pharmacokinetics (PKs) of many drugs. We undertook these studies to facilitate the evaluation and, where appropriate, quantification of the covariate effect of body fat percentage (BF%) on PK parameters in children. We examined two large databases to determine the values and variabilities of BF% in children with healthy body weights and in those with obesity, comparing the accuracy and precision of BF% estimation by both clinical methods and demographically derived techniques. Additionally, we conducted simulation studies to evaluate the utility of the several methods for application in clinical trials. BF% was correlated with body mass index (BMI), but was highly variable among both children with healthy body weights and those with obesity. Bio-impedance and several demographically derived techniques produced mean estimates of BF% that differed from dual x-ray absorptiometry by < 1% (accuracy) and a SD of 5% or less (precision). Simulation studies confirmed that when the differences in precision among the several methods were small compared with unexplained between-subject variability of a PK parameter, the techniques were of similar value in assessing the contribution of BF%, if any, as a covariate for that PK parameter. The combination of sex and obesity stage explained 68% of the variance of BF% with BMI. The estimation of BF% from sex and obesity stage can routinely be applied to PK clinical trials to evaluate the contribution of BF% as a potential covariate.

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Published In

Clin Transl Sci

DOI

EISSN

1752-8062

Publication Date

March 2021

Volume

14

Issue

2

Start / End Page

509 / 517

Location

United States

Related Subject Headings

  • Sex Factors
  • Prospective Studies
  • Obesity
  • Metabolic Clearance Rate
  • Male
  • Humans
  • General Clinical Medicine
  • Female
  • Electric Impedance
  • Datasets as Topic
 

Citation

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Green, T. P., Binns, H. J., Wu, H., Ariza, A. J., Perrin, E. M., Quadri, M., … Cohen-Wolkowiez, M. (2021). Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children. Clin Transl Sci, 14(2), 509–517. https://doi.org/10.1111/cts.12896
Green, Thomas P., Helen J. Binns, Huali Wu, Adolfo J. Ariza, Eliana M. Perrin, Maheen Quadri, Christoph P. Hornik, and Michael Cohen-Wolkowiez. “Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children.Clin Transl Sci 14, no. 2 (March 2021): 509–17. https://doi.org/10.1111/cts.12896.
Green TP, Binns HJ, Wu H, Ariza AJ, Perrin EM, Quadri M, et al. Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children. Clin Transl Sci. 2021 Mar;14(2):509–17.
Green, Thomas P., et al. “Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children.Clin Transl Sci, vol. 14, no. 2, Mar. 2021, pp. 509–17. Pubmed, doi:10.1111/cts.12896.
Green TP, Binns HJ, Wu H, Ariza AJ, Perrin EM, Quadri M, Hornik CP, Cohen-Wolkowiez M. Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children. Clin Transl Sci. 2021 Mar;14(2):509–517.
Journal cover image

Published In

Clin Transl Sci

DOI

EISSN

1752-8062

Publication Date

March 2021

Volume

14

Issue

2

Start / End Page

509 / 517

Location

United States

Related Subject Headings

  • Sex Factors
  • Prospective Studies
  • Obesity
  • Metabolic Clearance Rate
  • Male
  • Humans
  • General Clinical Medicine
  • Female
  • Electric Impedance
  • Datasets as Topic