Bisphenol A and Muscle Insulin Sensitivity
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glucose Metabolism Disorders
- Insulin Sensitivity
- Microtia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 (Participant, Outcomes Assessor)Masking Description: This study will be a double-blinded study. Research staff collecting data and participants will not know treatment allocation.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Both males and females
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...
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).
Tracking Information
- NCT #
- NCT03771066
- 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
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