Bisphenol A and Muscle Insulin Sensitivity

Study Overview
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Brief Summary
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This study examine oral bisphenol A consumption on muscle insulin sensitivity and hepatic glucose suppression. Half of the participants will receive a diet plus BPA and the other half will receive a diet plus no bisphenol A.

Detailed Description
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Evidence linking bisphenol A exposure with diabetes risk remains mainly associative in nature, and mechanism linking bisphenol A to type 2 diabetes remains unclear. The investigator's preliminary data suggests that in young adults, single oral BPA consumption significantly decreased glucose, insulin, and C-Peptide responses to an oral glucose tolerance test, suggesting that immediate consumption of bisphenol A has an effect on muscle insulin sensitivity, hepatic glucose suppression and/or digestion and absorption to lower blood glucose, insulin, and C-Peptide concentrations. The present experimental study evaluating the effects of bisphenol A over several days on the pathogenesis of type 2 diabetes will directly assess each of these potential mechanisms using gold standard measures (euglycemic hyperinsulinemic clamp technique and hepatic glucose suppression with glucose stable isotope infusion, and fecal microbiota).

Official Title
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Randomized Trial Examining Oral Consumption of Bisphenol A on Type 2 Diabetes Risk Markers

Conditions
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Insulin Sensitivity, Glucose Metabolism Disorders, Microtia

Intervention / Treatment
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* Behavioral: bisphenol A
* Behavioral: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-dieting sedentary (≤3 hour/week of aerobic exercise) normal-weight (BMI = 18.5 to 24.9 kg/m2) weight-stable for the previous 6 months free of any metabolic or chronic disease non-smoking, and sedentary Exclusion Criteria: Hemoglobin A1C based on the American Diabetes Association guidelines of 5.7 to 6.4% (Prediabetes) or >6.4% (Diabetes) impaired glucose tolerance type 1 diabetes type 2 diabetes colitis or any inflammatory bowel condition neurologic or psychiatric conditions smoking special diets (e.g. vegetarian, low-carbohydrate, Paleolithic, etc.) pregnant women or women trying to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This experimental study is a 2-group randomized, clinical trial comparing a 4-day energy balance diet plus oral BPA consumption at 50 ug/kg body weight (Diet+BPA) vs. 4-day energy balance diet plus oral placebo consumption (Diet+No BPA). Forty participants will be randomized to Diet+BPA and Diet+No BPA and will reside in a supervised environment at Cal Poly's sleep research facilities for 6 days (2-day baseline run-in, followed by 4-day treatment). Main outcome measures (muscle insulin sensitivity and hepatic glucose suppression) will be assessed at baseline and treatment periods.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet plus bisphenol A<br>Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight. | Behavioral: bisphenol A<br>* Vanilla wafer cookie with bisphenol A administered<br>|
| Placebo Comparator: Placebo<br>Participants will receive a 4-day diet plus no bisphenol A. | Behavioral: Placebo<br>* Vanilla wafer cookie with no bisphenol A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in rate of glucose disposal | Three hour euglycemic hyperinsulinemic clamp technique with stable glucose isotope infusion to determine rate of glucose disposal | Baseline and 4 days | 
| Change in rate of glucose appearance | Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance | Baseline and 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in concentration of insulin | Fasting blood sample for insulin concentration | Baseline and 4 days | 
| Change in concentration of glucose | Fasting blood sample for glucose concentration | Baseline and 4 days | 
| Change in concentration of c-peptide | Fasting blood sample for c-peptide concentration | Baseline and 4 days | 
| Change in concentration of proinsulin | Fasting blood sample for proinsulin | Baseline and 4 days | 
| Change in concentration of adiponectin | Fasting blood sample for adiponectin | Baseline and 4 days | 
| Change in concentration of 17-beta estradiol | Fasting blood sample for 17-beta estradiol | Baseline and 4 days | 
| Change in concentration of firmicutes | Fecal microbiome concentration of firmicutes | Baseline and 4 days | 
| Change in concentration of clostridia | Fecal microbiome concentration of clostridia | Baseline and 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bisphenol A, diet