Bisphenol A and Muscle Insulin Sensitivity
Primary Purpose
Insulin Sensitivity, Glucose Metabolism Disorders, Microtia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bisphenol A
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Sensitivity focused on measuring bisphenol A, diet
Eligibility Criteria
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
Sites / Locations
- California Polytechnic State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Diet plus bisphenol A
Placebo
Arm Description
Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight.
Participants will receive a 4-day diet plus no bisphenol A.
Outcomes
Primary Outcome Measures
Change in rate of glucose disposal
Three hour euglycemic hyperinsulinemic clamp technique with stable glucose isotope infusion to determine rate of glucose disposal
Change in rate of glucose appearance
Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance
Secondary Outcome Measures
Change in concentration of insulin
Fasting blood sample for insulin concentration
Change in concentration of glucose
Fasting blood sample for glucose concentration
Change in concentration of c-peptide
Fasting blood sample for c-peptide concentration
Change in concentration of proinsulin
Fasting blood sample for proinsulin
Change in concentration of adiponectin
Fasting blood sample for adiponectin
Change in concentration of 17-beta estradiol
Fasting blood sample for 17-beta estradiol
Change in concentration of firmicutes
Fecal microbiome concentration of firmicutes
Change in concentration of clostridia
Fecal microbiome concentration of clostridia
Full Information
NCT ID
NCT03771066
First Posted
December 6, 2018
Last Updated
January 25, 2021
Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT03771066
Brief Title
Bisphenol A and Muscle Insulin Sensitivity
Official Title
Randomized Trial Examining Oral Consumption of Bisphenol A on Type 2 Diabetes Risk Markers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
American Diabetes Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Glucose Metabolism Disorders, Microtia
Keywords
bisphenol A, diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
This study will be a double-blinded study. Research staff collecting data and participants will not know treatment allocation.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diet plus bisphenol A
Arm Type
Experimental
Arm Description
Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a 4-day diet plus no bisphenol A.
Intervention Type
Behavioral
Intervention Name(s)
bisphenol A
Intervention Description
Vanilla wafer cookie with bisphenol A administered
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
Vanilla wafer cookie with no bisphenol A
Primary Outcome Measure Information:
Title
Change in rate of glucose disposal
Description
Three hour euglycemic hyperinsulinemic clamp technique with stable glucose isotope infusion to determine rate of glucose disposal
Time Frame
Baseline and 4 days
Title
Change in rate of glucose appearance
Description
Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance
Time Frame
Baseline and 4 days
Secondary Outcome Measure Information:
Title
Change in concentration of insulin
Description
Fasting blood sample for insulin concentration
Time Frame
Baseline and 4 days
Title
Change in concentration of glucose
Description
Fasting blood sample for glucose concentration
Time Frame
Baseline and 4 days
Title
Change in concentration of c-peptide
Description
Fasting blood sample for c-peptide concentration
Time Frame
Baseline and 4 days
Title
Change in concentration of proinsulin
Description
Fasting blood sample for proinsulin
Time Frame
Baseline and 4 days
Title
Change in concentration of adiponectin
Description
Fasting blood sample for adiponectin
Time Frame
Baseline and 4 days
Title
Change in concentration of 17-beta estradiol
Description
Fasting blood sample for 17-beta estradiol
Time Frame
Baseline and 4 days
Title
Change in concentration of firmicutes
Description
Fecal microbiome concentration of firmicutes
Time Frame
Baseline and 4 days
Title
Change in concentration of clostridia
Description
Fecal microbiome concentration of clostridia
Time Frame
Baseline and 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Hagobian, PhD
Phone
805-756-7511
Email
thagobia@calpoly.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Adam seal
Phone
805-756-5573
Email
adseal@calpoly.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Hagobian, PhD
Organizational Affiliation
California Polytechnic State University-San Luis Obispo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hannah Brunner-Gaydos
Organizational Affiliation
California Polytechnic State University-San Luis Obispo
Official's Role
Study Director
Facility Information:
Facility Name
California Polytechnic State University
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Hagobian, PhD
Phone
805-756-7511
Email
thagobia@calpoly.edu
First Name & Middle Initial & Last Name & Degree
Hannah Brunner-Gaydos
Phone
805-756-5573
Email
hbrunner@calpoly.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://digitalcommons.calpoly.edu
Learn more about this trial
Bisphenol A and Muscle Insulin Sensitivity
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