Insulin SensitivityNCT03771066
Bisphenol A and Muscle Insulin Sensitivity
A study testing bisphenol A in people with Insulin Sensitivity and Glucose Metabolism Disorders, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Glucose Metabolism Disorders, Microtia
- What is being tested?
- bisphenol A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- smoking
- special diets (e.g. vegetarian, low-carbohydrate, Paleolithic, etc.)
- pregnant women or women trying to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
California Polytechnic State University
San Luis Obispo, California, 93405
About this study
Official title: Randomized Trial Examining Oral Consumption of Bisphenol A on Type 2 Diabetes Risk Markers
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.
Read the 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).
- Conditions
- Insulin Sensitivity, Glucose Metabolism Disorders, Microtia
- Being tested
- bisphenol A, Placebo
- Keywords
- bisphenol A, diet
- Medical subject headings
- Insulin Resistance, Glucose Metabolism Disorders, Congenital Microtia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bisphenol ABehavioural
Vanilla wafer cookie with bisphenol A administered
PlaceboBehavioural
Vanilla wafer cookie with no bisphenol A
| Study group | Role | What they receive |
|---|---|---|
| Diet plus bisphenol A | Experimental | Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight. Receives: Behavioral: bisphenol A |
| Placebo | Placebo comparator | Participants will receive a 4-day diet plus no bisphenol A. Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of glucose disposal
Three hour euglycemic hyperinsulinemic clamp technique with stable glucose isotope infusion to determine rate of glucose disposal
Measured: Baseline and 4 days
Change in rate of glucose appearance
Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance
Measured: Baseline and 4 days
Secondary outcomes (8)
Change in concentration of insulin
Fasting blood sample for insulin concentration
Measured: Baseline and 4 days
Change in concentration of glucose
Fasting blood sample for glucose concentration
Measured: Baseline and 4 days
Change in concentration of c-peptide
Fasting blood sample for c-peptide concentration
Measured: Baseline and 4 days
Change in concentration of proinsulin
Fasting blood sample for proinsulin
Measured: Baseline and 4 days
Change in concentration of adiponectin
Fasting blood sample for adiponectin
Measured: Baseline and 4 days
Change in concentration of 17-beta estradiol
Fasting blood sample for 17-beta estradiol
Measured: Baseline and 4 days
Change in concentration of firmicutes
Fecal microbiome concentration of firmicutes
Measured: Baseline and 4 days
Change in concentration of clostridia
Fecal microbiome concentration of clostridia
Measured: Baseline and 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Todd Hagobian, California Polytechnic State University-San Luis Obispo
- Investigators
- Todd Hagobian, PhD, Principal investigator, California Polytechnic State University-San Luis ObispoHannah Brunner-Gaydos, Study director, California Polytechnic State University-San Luis Obispo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771066
- Sponsor's protocol ID
- 2018-149-CP
- Status last verified
- Jul 2024
- First submitted
- 6 Dec 2018
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Examining Oral Consumption of Bisphenol A on Type 2 Diabetes Risk Markers
- ClinicalTrials.gov ID
- NCT03771066
- Acronym / sponsor ID
- 2018-149-CP
- Conditions
- Insulin Sensitivity, Glucose Metabolism Disorders, Microtia
- Keywords
- bisphenol A, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diet plus bisphenol A | Experimental | Behavioral: bisphenol AParticipants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight. |
| Placebo | Placebo comparator | Behavioral: PlaceboParticipants will receive a 4-day diet plus no bisphenol A. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bisphenol AVanilla wafer cookie with bisphenol A administered | Behavioural | Diet plus bisphenol A |
| PlaceboVanilla wafer cookie with no bisphenol A | Behavioural | Placebo |
Primary outcome
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
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
8 secondary outcomes
Change in concentration of insulin
Time frame: Baseline and 4 days
Change in concentration of glucose
Time frame: Baseline and 4 days
Change in concentration of c-peptide
Time frame: Baseline and 4 days
Change in concentration of proinsulin
Time frame: Baseline and 4 days
Change in concentration of adiponectin
Time frame: Baseline and 4 days
Change in concentration of 17-beta estradiol
Time frame: Baseline and 4 days
Change in concentration of firmicutes
Time frame: Baseline and 4 days
Change in concentration of clostridia
Time frame: Baseline and 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Hagobian, PhD principal investigator
California Polytechnic State University-San Luis Obispo
Hannah Brunner-Gaydos study director
California Polytechnic State University-San Luis Obispo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bisphenol A in people with Insulin Sensitivity and Glucose Metabolism Disorders, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of glucose disposal (time frame: Baseline and 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.