Clinical Trials Directory

Trials / Completed

CompletedNCT03444922

Effects of BPA on Insulin and Glucose Responses

Effects of Oral Ingestion of BPA on Insulin and Glucose Responses

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
California Polytechnic State University-San Luis Obispo · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPlaceboIngestion of Placebo
OTHERBPA 4 ug/kg BWOral BPA ingestion of 4 ug/kg BW
OTHERBPA 50 ug/kg BWOral BPA ingestion of 50 ug/kg BW

Timeline

Start date
2016-09-01
Primary completion
2019-02-14
Completion
2019-02-14
First posted
2018-02-26
Last updated
2019-02-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03444922. Inclusion in this directory is not an endorsement.