Effects of BPA on Insulin and Glucose Responses

Environmental Exposure Clinical Trial

Official title:

Effects of Oral Ingestion of BPA on Insulin and Glucose Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444922
• Other study ID #: CPJune62018
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: February 14, 2019

Study information

• Verified date: February 2019
• Source: California Polytechnic State University-San Luis Obispo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 14, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Environmental Exposure

Intervention

Other:
• Placebo
Ingestion of Placebo
• BPA 4 ug/kg BW
Oral BPA ingestion of 4 ug/kg BW
• BPA 50 ug/kg BW
Oral BPA ingestion of 50 ug/kg BW

Locations

Country	Name	City	State
United States	California Polytechnic State University	San Luis Obispo	California

Sponsors (1)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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