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Completed

NCT Number: NCT03771066

Bisphenol A and Muscle Insulin Sensitivity

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Polytechnic State University

San Luis Obispo, California, 93405, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bisphenol A

Behavioral

Vanilla wafer cookie with bisphenol A administered

Placebo

Behavioral

Vanilla wafer cookie with no bisphenol A

Primary outcomes

  1. Change in rate of glucose disposal

    Time frame: Baseline and 4 days

    Three hour euglycemic hyperinsulinemic clamp technique with stable glucose isotope infusion to determine rate of glucose disposal

  2. Change in rate of glucose appearance

    Time frame: Baseline and 4 days

    Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance

Secondary outcomes

  1. Change in concentration of insulin

    Time frame: Baseline and 4 days

    Fasting blood sample for insulin concentration

  2. Change in concentration of glucose

    Time frame: Baseline and 4 days

    Fasting blood sample for glucose concentration

  3. Change in concentration of c-peptide

    Time frame: Baseline and 4 days

    Fasting blood sample for c-peptide concentration

  4. Change in concentration of proinsulin

    Time frame: Baseline and 4 days

    Fasting blood sample for proinsulin

  5. Change in concentration of adiponectin

    Time frame: Baseline and 4 days

    Fasting blood sample for adiponectin

  6. Change in concentration of 17-beta estradiol

    Time frame: Baseline and 4 days

    Fasting blood sample for 17-beta estradiol

  7. Change in concentration of firmicutes

    Time frame: Baseline and 4 days

    Fecal microbiome concentration of firmicutes

  8. Change in concentration of clostridia

    Time frame: Baseline and 4 days

    Fecal microbiome concentration of clostridia

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2018
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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