Environmental Exposure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERPlacebo
Ingestion of Placebo
OTHERBPA 4 ug/kg BW
Oral BPA ingestion of 4 ug/kg BW
OTHERBPA 50 ug/kg BW
Oral BPA ingestion of 50 ug/kg BW
Sponsors
California Polytechnic State University-San Luis Obispo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Double-blinded study; Study statistician computer generated randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI = 18.5-35 * Age 18-50 years * Non-smoking * English speaking
Exclusion criteria
* History of infertility * Type 2 or Type 1 diabetes * Cardiovascular disease, or any other metabolic disease/complication * Hypertension (systolic blood pressure ≥140, diastolic blood pressure ≥90) assessed by sphygmomanometer * History of major psychiatric illness, drug abuse, or unsafe dieting practices * History of bariatric surgery * Pregnant women or women expecting or trying to become pregnant * Participating in other studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Glucose at 180 Minutes | 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180 | Glucose concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Insulin at 180 Minutes | 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180 | Insulin concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test |
| Change From Baseline Estrogen at 180 Minutes | 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180 | Estrogen concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test |
| Change From Baseline C-Peptde at 180 Minutes | 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180 | C-Peptide concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test |
| Change From Baseline Pro-Insulin at 180 Minutes | 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180 | Pro-Insulin concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test |
| Change From Baseline Triglycerides at 180 Minutes | 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180 | Triglyceride concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test |
Countries
United States
Outcome results
None listed