Effects of BPA on Insulin and Glucose Responses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2019-02-14

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.

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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.

Conditions

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Environmental Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Double-blinded study; Study statistician computer generated randomization

Study Groups

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Placebo

Participants consume Vanilla Wafer cookie

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Ingestion of Placebo

BPA 4 ug/kg BW

Participants consume 4 ug/kg BW of BPA on a Vanilla Wafer Cookie

Group Type EXPERIMENTAL

BPA 4 ug/kg BW

Intervention Type OTHER

Oral BPA ingestion of 4 ug/kg BW

BPA 50 ug/kg BW

Participants consume 50 ug/kg BW of BPA on a Vanilla Wafer Cookie

Group Type EXPERIMENTAL

BPA 50 ug/kg BW

Intervention Type OTHER

Oral BPA ingestion of 50 ug/kg BW

Interventions

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Placebo

Ingestion of Placebo

Intervention Type OTHER

BPA 4 ug/kg BW

Oral BPA ingestion of 4 ug/kg BW

Intervention Type OTHER

BPA 50 ug/kg BW

Oral BPA ingestion of 50 ug/kg BW

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes