Bisphenol A and Muscle Insulin Sensitivity

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

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.

Study Overview

• Status: Unknown
• Conditions: Glucose Metabolism Disorders; Insulin Sensitivity; Microtia
• Intervention / Treatment: Behavioral: bisphenol A; Behavioral: Placebo

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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Todd Hagobian, PhD; Phone Number: 805-756-7511; Email: thagobia@calpoly.edu
• Study Contact Backup: Name: Adam seal; Phone Number: 805-756-5573; Email: adseal@calpoly.edu

Study Locations

• United States
  • California
    • San Luis Obispo, California, United States, 93405
      • Recruiting
      • California Polytechnic State University
      • Contact: Todd Hagobian, PhD; Phone Number: 805-756-7511; Email: thagobia@calpoly.edu
      • Contact: Hannah Brunner-Gaydos; Phone Number: 805-756-5573; Email: hbrunner@calpoly.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: California Polytechnic State University-San Luis Obispo
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Todd Hagobian, PhD, California Polytechnic State University-San Luis Obispo; Study Director: Hannah Brunner-Gaydos, California Polytechnic State University-San Luis Obispo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: diet; bisphenol A
• Additional Relevant MeSH Terms: Immune System Diseases; Congenital Abnormalities; Otorhinolaryngologic Diseases; Ear Diseases; Hyperinsulinism; Hypersensitivity; Insulin Resistance; Metabolic Diseases; Glucose Metabolism Disorders; Congenital Microtia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Estrogens, Non-Steroidal; Estrogens; Antioxidants; Free Radical Scavengers; Bisphenol A
• Other Study ID Numbers: 2018-149-CP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion, and will be available indefinitely.
• IPD Sharing Access Criteria: Data access will be freely available for download on the Cal Poly Digital Commons website. Requestors will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No