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
Todd A HagobianSuzanne Phelan

Abstract

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 energ...Continue Reading

Citations

May 24, 2021·Environmental Science and Pollution Research International·Kazım KöseLokman Uzun

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Methods Mentioned

BETA
pregnancy test
X-ray
enzyme-linked immunosorbent assay
urine collection
ELISA

Clinical Trials Mentioned

NCT03771066

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