Effects of BPA on Insulin and Glucose Responses

Effects of Oral Ingestion of BPA on Insulin and Glucose Responses

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.

Study Overview

• Status: Completed
• Conditions: Environmental Exposure
• Intervention / Treatment: Other: Placebo; Other: BPA 4 ug/kg BW; Other: BPA 50 ug/kg BW

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Luis Obispo, California, United States, 93405
      • California Polytechnic State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: California Polytechnic State University-San Luis Obispo
• Investigators: Principal Investigator: Todd Hagobian, PhD, California Polytechnic State University-San Luis Obispo

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): February 14, 2019

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CPJune62018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share data in this pilot study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No