Effects of BPA on Insulin and Glucose Responses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Oral Ingestion of BPA on Insulin and Glucose Responses

Conditions
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Environmental Exposure

Intervention / Treatment
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* Other: Placebo
* Other: BPA 4 ug/kg BW
* Other: BPA 50 ug/kg BW


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants consume Vanilla Wafer cookie | Other: Placebo<br>* Ingestion of Placebo<br>|
| Experimental: BPA 4 ug/kg BW<br>Participants consume 4 ug/kg BW of BPA on a Vanilla Wafer Cookie | Other: BPA 4 ug/kg BW<br>* Oral BPA ingestion of 4 ug/kg BW<br>|
| Experimental: BPA 50 ug/kg BW<br>Participants consume 50 ug/kg BW of BPA on a Vanilla Wafer Cookie | Other: BPA 50 ug/kg BW<br>* Oral BPA ingestion of 50 ug/kg BW<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Glucose at 180 Minutes | Glucose concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test | 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Insulin at 180 Minutes | Insulin concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test | 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 | 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 | 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 | 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 | 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180 |