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Bisphenol A and Muscle Insulin Sensitivity

California Polytechnic State University (Cal Poly) logo

California Polytechnic State University (Cal Poly)

Status

Completed

Conditions

Glucose Metabolism Disorders
Microtia
Insulin Sensitivity

Treatments

Behavioral: bisphenol A
Behavioral: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03771066
2018-149-CP

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

Diet plus bisphenol A
Experimental group
Description:
Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight.
Treatment:
Behavioral: bisphenol A
Placebo
Placebo Comparator group
Description:
Participants will receive a 4-day diet plus no bisphenol A.
Treatment:
Behavioral: Placebo

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Adam seal; Todd Hagobian, PhD

Data sourced from clinicaltrials.gov

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