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
| Type | Name | Description |
|---|---|---|
| OTHER | Placebo | Ingestion of Placebo |
| OTHER | BPA 4 ug/kg BW | Oral BPA ingestion of 4 ug/kg BW |
| OTHER | BPA 50 ug/kg BW | Oral 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.