Rationale and design of a randomized controlled trial examining oral administration of bisphenol A on hepatic glucose production and skeletal muscle insulin sensitivity in adults
Previous observational studies have shown that the endocrine disrupting chemical bisphenol A (BPA) is associated with type 2 diabetes, but few studies have examined direct effects of BPA on human health. The purpose of this study is to determine whether orally administered BPA at the US Environmenta...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2020-03-01
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| Series: | Contemporary Clinical Trials Communications |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865420300338 |
| _version_ | 1818852086831382528 |
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| author | Todd A. Hagobian Hannah Brunner-Gaydos Adam Seal Andrew Schaffner Chris Kitts Ryan Hubbard Steven K. Malin Michael R. La Frano Kelly A. Bennion Suzanne Phelan |
| author_facet | Todd A. Hagobian Hannah Brunner-Gaydos Adam Seal Andrew Schaffner Chris Kitts Ryan Hubbard Steven K. Malin Michael R. La Frano Kelly A. Bennion Suzanne Phelan |
| author_sort | Todd A. Hagobian |
| collection | DOAJ |
| description | Previous observational studies have shown that the endocrine disrupting chemical bisphenol A (BPA) is associated with type 2 diabetes, but few studies have examined direct effects of BPA on human health. The purpose of this study is to determine whether orally administered BPA at the US Environmental Protection Agency (EPA) safe dose of 50 μg/kg body weight has an adverse effect on hepatic glucose production and skeletal muscle insulin sensitivity. Forty, non-habitually active, healthy adults of normal weight will be enrolled. Participants will begin with a 2-day baseline energy balance diet low in bisphenols in which urine and blood will be collected, and standard tests performed to assess the primary outcome measures of hepatic glucose production (via [6,6-2H] glucose infusion) and skeletal muscle insulin sensitivity (via euglycemic hyperinsulinemic clamp technique). Secondary outcome measures are fasting hormones/endocrine factors (insulin, glucose, C-peptide, Pro-insulin, adiponectin, 17-beta-estradiol, free fatty acids) related to the pathogenesis of type 2 diabetes. Participants will then be randomly assigned to a 4-day energy balance diet plus oral administration of BPA at 50 μg/kg body weight (Diet + BPA) or 4-day energy balance diet plus oral administration of placebo (Diet + No BPA); all outcome measures will be reassessed after 4 days. Findings from this study will provide a framework for other studies in this area, and provide much needed experimental evidence using gold standard measures as to whether oral BPA administration over several days poses any risk of type 2 diabetes. Keywords: Bisphenol A, Administration, Diabetes, Insulin sensitivity, Glucose |
| first_indexed | 2024-12-19T07:15:20Z |
| format | Article |
| id | doaj.art-efacb2ede27746559693d34ebd1f2006 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-19T07:15:20Z |
| publishDate | 2020-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-efacb2ede27746559693d34ebd1f20062022-12-21T20:31:06ZengElsevierContemporary Clinical Trials Communications2451-86542020-03-0117Rationale and design of a randomized controlled trial examining oral administration of bisphenol A on hepatic glucose production and skeletal muscle insulin sensitivity in adultsTodd A. Hagobian0Hannah Brunner-Gaydos1Adam Seal2Andrew Schaffner3Chris Kitts4Ryan Hubbard5Steven K. Malin6Michael R. La Frano7Kelly A. Bennion8Suzanne Phelan9Center for Health Research, California Polytechnic State University, USA; Department of Kinesiology and Public Health, California Polytechnic State University, USA; Corresponding author. Department of Kinesiology and Public Health, Co-Director of Center for Health Research, California Polytechnic State University, 1 Grand Avenue, San Luis Obispo, CA, 93407, USA.Center for Health Research, California Polytechnic State University, USA; Department of Kinesiology and Public Health, California Polytechnic State University, USACenter for Health Research, California Polytechnic State University, USA; Department of Kinesiology and Public Health, California Polytechnic State University, USACenter for Health Research, California Polytechnic State University, USA; Department of Statistics, California Polytechnic State University, USADepartment of Biology, California Polytechnic State University, USACampus Health and Wellbeing, California Polytechnic State University, USADepartment of Kinesiology, University of Virginia, USACenter for Health Research, California Polytechnic State University, USA; Department of Food Science and Nutrition, California Polytechnic State University, USACenter for Health Research, California Polytechnic State University, USA; Department of Psychology and Child Development, California Polytechnic State University, USACenter for Health Research, California Polytechnic State University, USA; Department of Kinesiology and Public Health, California Polytechnic State University, USAPrevious observational studies have shown that the endocrine disrupting chemical bisphenol A (BPA) is associated with type 2 diabetes, but few studies have examined direct effects of BPA on human health. The purpose of this study is to determine whether orally administered BPA at the US Environmental Protection Agency (EPA) safe dose of 50 μg/kg body weight has an adverse effect on hepatic glucose production and skeletal muscle insulin sensitivity. Forty, non-habitually active, healthy adults of normal weight will be enrolled. Participants will begin with a 2-day baseline energy balance diet low in bisphenols in which urine and blood will be collected, and standard tests performed to assess the primary outcome measures of hepatic glucose production (via [6,6-2H] glucose infusion) and skeletal muscle insulin sensitivity (via euglycemic hyperinsulinemic clamp technique). Secondary outcome measures are fasting hormones/endocrine factors (insulin, glucose, C-peptide, Pro-insulin, adiponectin, 17-beta-estradiol, free fatty acids) related to the pathogenesis of type 2 diabetes. Participants will then be randomly assigned to a 4-day energy balance diet plus oral administration of BPA at 50 μg/kg body weight (Diet + BPA) or 4-day energy balance diet plus oral administration of placebo (Diet + No BPA); all outcome measures will be reassessed after 4 days. Findings from this study will provide a framework for other studies in this area, and provide much needed experimental evidence using gold standard measures as to whether oral BPA administration over several days poses any risk of type 2 diabetes. Keywords: Bisphenol A, Administration, Diabetes, Insulin sensitivity, Glucosehttp://www.sciencedirect.com/science/article/pii/S2451865420300338 |
| spellingShingle | Todd A. Hagobian Hannah Brunner-Gaydos Adam Seal Andrew Schaffner Chris Kitts Ryan Hubbard Steven K. Malin Michael R. La Frano Kelly A. Bennion Suzanne Phelan Rationale and design of a randomized controlled trial examining oral administration of bisphenol A on hepatic glucose production and skeletal muscle insulin sensitivity in adults Contemporary Clinical Trials Communications |
| title | Rationale and design of a randomized controlled trial examining oral administration of bisphenol A on hepatic glucose production and skeletal muscle insulin sensitivity in adults |
| title_full | Rationale and design of a randomized controlled trial examining oral administration of bisphenol A on hepatic glucose production and skeletal muscle insulin sensitivity in adults |
| title_fullStr | Rationale and design of a randomized controlled trial examining oral administration of bisphenol A on hepatic glucose production and skeletal muscle insulin sensitivity in adults |
| title_full_unstemmed | Rationale and design of a randomized controlled trial examining oral administration of bisphenol A on hepatic glucose production and skeletal muscle insulin sensitivity in adults |
| title_short | Rationale and design of a randomized controlled trial examining oral administration of bisphenol A on hepatic glucose production and skeletal muscle insulin sensitivity in adults |
| title_sort | rationale and design of a randomized controlled trial examining oral administration of bisphenol a on hepatic glucose production and skeletal muscle insulin sensitivity in adults |
| url | http://www.sciencedirect.com/science/article/pii/S2451865420300338 |
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