Clinical trial NCT03771066: Bisphenol A and Muscle Insulin Sensitivity
Official title: Randomized Trial Examining Oral Consumption of Bisphenol A on Type 2 Diabetes Risk Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Glucose Metabolism Disorders
Microtia
Keywords: bisphenol A
diet
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2018-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in rate of glucose disposal
timeFrame: Baseline and 4 days
measure: Change in rate of glucose appearance
timeFrame: Baseline and 4 days
Secondary outcomes:
measure: Change in concentration of insulin
timeFrame: Baseline and 4 days
measure: Change in concentration of glucose
timeFrame: Baseline and 4 days
measure: Change in concentration of c-peptide
timeFrame: Baseline and 4 days
measure: Change in concentration of proinsulin
timeFrame: Baseline and 4 days
measure: Change in concentration of adiponectin
timeFrame: Baseline and 4 days
measure: Change in concentration of 17-beta estradiol
timeFrame: Baseline and 4 days
measure: Change in concentration of firmicutes
timeFrame: Baseline and 4 days
measure: Change in concentration of clostridia
timeFrame: Baseline and 4 days
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
affiliation: California Polytechnic State University-San Luis Obispo
name: Hannah Brunner-Gaydos
role: STUDY_DIRECTOR
References: