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NCT Number: NCT03444922

Effects 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.

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Key information

Conditions

Environmental Exposure

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Polytechnic State University

San Luis Obispo, California, 93405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

Ingestion of Placebo

BPA 4 ug/kg BW

Other

Oral BPA ingestion of 4 ug/kg BW

BPA 50 ug/kg BW

Other

Oral BPA ingestion of 50 ug/kg BW

Primary outcomes

  1. Change From Baseline Glucose at 180 Minutes

    Time frame: 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 outcomes

  1. Change From Baseline Insulin at 180 Minutes

    Time frame: 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

  2. Change From Baseline Estrogen at 180 Minutes

    Time frame: 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

  3. Change From Baseline C-Peptde at 180 Minutes

    Time frame: 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

  4. Change From Baseline Pro-Insulin at 180 Minutes

    Time frame: 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

  5. Change From Baseline Triglycerides at 180 Minutes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Registry information

Official study title

Effects of Oral Ingestion of BPA on Insulin and Glucose Responses

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2018
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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