Clinical trial NCT03444922: Effects of BPA on Insulin and Glucose Responses
Official title: Effects of Oral Ingestion of BPA on Insulin and Glucose Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Exposure
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline Glucose at 180 Minutes
timeFrame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Secondary outcomes:
measure: Change From Baseline Insulin at 180 Minutes
timeFrame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
measure: Change From Baseline Estrogen at 180 Minutes
timeFrame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
measure: Change From Baseline C-Peptde at 180 Minutes
timeFrame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
measure: Change From Baseline Pro-Insulin at 180 Minutes
timeFrame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
measure: Change From Baseline Triglycerides at 180 Minutes
timeFrame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
Study officials:
affiliation: California Polytechnic State University-San Luis Obispo
name: Todd Hagobian, PhD
role: PRINCIPAL_INVESTIGATOR
References: