The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Thus, the primary purpose of this study is to determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides). Findings from this pilot study will inform public health recommendations for food packaging and provide much needed experimental evidence as to whether BPA poses any public health risk.
The prevalence of diabetes is well established affecting \>29 million Americans with 90-95% of these individuals diagnosed with type 2 diabetes. The etiology of type 2 diabetes is not fully understood, but clearly diet, physical activity, and genetics play roles. Emerging data suggests a novel hypothesis that synthetic non-persistent endocrine disruptors used in a variety of common consumer goods, including the industry-produced chemical bisphenol A (BPA) play a pivotal role in type 2 diabetes and obesity rates. In support of this hypothesis, National Health and Nutrition Examination Survey (NHANES), Nurses' Health Study II (NHSII), and other cross-sectional data have shown associations between urinary BPA concentrations and type-2 diabetes, pre-diabetes, insulin resistance, and hemoglobin A1c. The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Thus, the primary purpose of this study is to determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides) in the pathogenesis of Type 2 diabetes and cardiovascular disease. Findings from this pilot study will inform public health recommendations for food packaging and provide much needed experimental evidence as to whether BPA poses any public health risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
11
Ingestion of Placebo
Oral BPA ingestion of 4 ug/kg BW
Oral BPA ingestion of 50 ug/kg BW
California Polytechnic State University
San Luis Obispo, California, United States
Change From Baseline Glucose at 180 Minutes
Glucose concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline Insulin at 180 Minutes
Insulin concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline Estrogen at 180 Minutes
Estrogen concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline C-Peptde at 180 Minutes
C-Peptide concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline Pro-Insulin at 180 Minutes
Pro-Insulin concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline Triglycerides at 180 Minutes
Triglyceride concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
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