Bisphenol A and Muscle Insulin Sensitivity

Insulin Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03771066
• Other study ID #: 2018-149-CP
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: California Polytechnic State University-San Luis Obispo
• Contact: Todd Hagobian, PhD
• Phone: 805-756-7511
• Email: thagobia[@]calpoly.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Metabolic Diseases
• Microtia

Intervention

Behavioral:
• bisphenol A
Vanilla wafer cookie with bisphenol A administered
• Placebo
Vanilla wafer cookie with no bisphenol A

Locations

Country	Name	City	State
United States	California Polytechnic State University	San Luis Obispo	California

Sponsors (2)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in rate of glucose appearance	Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance	Baseline and 4 days
Secondary	Change in concentration of insulin	Fasting blood sample for insulin concentration	Baseline and 4 days
Secondary	Change in concentration of glucose	Fasting blood sample for glucose concentration	Baseline and 4 days
Secondary	Change in concentration of c-peptide	Fasting blood sample for c-peptide concentration	Baseline and 4 days
Secondary	Change in concentration of proinsulin	Fasting blood sample for proinsulin	Baseline and 4 days
Secondary	Change in concentration of adiponectin	Fasting blood sample for adiponectin	Baseline and 4 days
Secondary	Change in concentration of 17-beta estradiol	Fasting blood sample for 17-beta estradiol	Baseline and 4 days
Secondary	Change in concentration of firmicutes	Fecal microbiome concentration of firmicutes	Baseline and 4 days
Secondary	Change in concentration of clostridia	Fecal microbiome concentration of clostridia	Baseline and 4 days