Environmental ExposureNCT03444922
Effects of BPA on Insulin and Glucose Responses
A study testing BPA 4 ug/kg BW and BPA 50 ug/kg BW in people with Environmental Exposure, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial summary
The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure
- What is being tested?
- BPA 4 ug/kg BW and BPA 50 ug/kg BW
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 14 Feb 2019
- 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
- BMI = 18.5-35
- Age 18-50 years
- Non-smoking
- English speaking
Who cannot join
- History of infertility
- Type 2 or Type 1 diabetes
- Cardiovascular disease, or any other metabolic disease/complication
- Hypertension (systolic blood pressure ≥140, diastolic blood pressure ≥90) assessed by sphygmomanometer
- History of major psychiatric illness, drug abuse, or unsafe dieting practices
- History of bariatric surgery
- Pregnant women or women expecting or trying to become pregnant
- Participating in other studies
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: Effects of Oral Ingestion of BPA on Insulin and Glucose Responses
The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Thus, the primary purpose of this study is to determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides). Findings from this pilot study will inform public health recommendations for food packaging and provide much needed experimental evidence as to whether BPA poses any public health risk.
Read the detailed description
The prevalence of diabetes is well established affecting >29 million Americans with 90-95% of these individuals diagnosed with type 2 diabetes. The etiology of type 2 diabetes is not fully understood, but clearly diet, physical activity, and genetics play roles. Emerging data suggests a novel hypothesis that synthetic non-persistent endocrine disruptors used in a variety of common consumer goods, including the industry-produced chemical bisphenol A (BPA) play a pivotal role in type 2 diabetes and obesity rates. In support of this hypothesis, National Health and Nutrition Examination Survey (NHANES), Nurses' Health Study II (NHSII), and other cross-sectional data have shown associations between urinary BPA concentrations and type-2 diabetes, pre-diabetes, insulin resistance, and hemoglobin A1c. The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Thus, the primary purpose of this study is to determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides) in the pathogenesis of Type 2 diabetes and cardiovascular disease. Findings from this pilot study will inform public health recommendations for food packaging and provide much needed experimental evidence as to whether BPA poses any public health risk.
- Conditions
- Environmental Exposure
- Being tested
- Placebo, BPA 4 ug/kg BW, BPA 50 ug/kg BW
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Ingestion of Placebo
BPA 4 ug/kg BWOther
Oral BPA ingestion of 4 ug/kg BW
BPA 50 ug/kg BWOther
Oral BPA ingestion of 50 ug/kg BW
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants consume Vanilla Wafer cookie Receives: Other: Placebo |
| BPA 4 ug/kg BW | Experimental | Participants consume 4 ug/kg BW of BPA on a Vanilla Wafer Cookie Receives: Other: BPA 4 ug/kg BW |
| BPA 50 ug/kg BW | Experimental | Participants consume 50 ug/kg BW of BPA on a Vanilla Wafer Cookie Receives: Other: BPA 50 ug/kg BW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Glucose at 180 Minutes
Glucose concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Measured: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Secondary outcomes (5)
Change From Baseline Insulin at 180 Minutes
Insulin concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Measured: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline Estrogen at 180 Minutes
Estrogen concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Measured: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline C-Peptde at 180 Minutes
C-Peptide concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Measured: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline Pro-Insulin at 180 Minutes
Pro-Insulin concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Measured: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline Triglycerides at 180 Minutes
Triglyceride concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
Measured: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Sep 2016
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- 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 Obispo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444922
- Sponsor's protocol ID
- CPJune62018
- Status last verified
- Feb 2019
- First submitted
- 8 Feb 2018
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data in this pilot study
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Ingestion of BPA on Insulin and Glucose Responses
- ClinicalTrials.gov ID
- NCT03444922
- Acronym / sponsor ID
- CPJune62018
- Conditions
- Environmental Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 26 Feb 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.
The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Thus, the primary purpose of this study is to determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides). Findings from this pilot study will inform public health recommendations for food packaging and provide much needed experimental evidence as to whether BPA poses any public health risk.
Detailed description
The prevalence of diabetes is well established affecting >29 million Americans with 90-95% of these individuals diagnosed with type 2 diabetes. The etiology of type 2 diabetes is not fully understood, but clearly diet, physical activity, and genetics play roles. Emerging data suggests a novel hypothesis that synthetic non-persistent endocrine disruptors used in a variety of common consumer goods, including the industry-produced chemical bisphenol A (BPA) play a pivotal role in type 2 diabetes and obesity rates. In support of this hypothesis, National Health and Nutrition Examination Survey (NHANES), Nurses' Health Study II (NHSII), and other cross-sectional data have shown associations between urinary BPA concentrations and type-2 diabetes, pre-diabetes, insulin resistance, and hemoglobin A1c. The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Thus, the primary purpose of this study is to determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides) in the pathogenesis of Type 2 diabetes and cardiovascular disease. Findings from this pilot study will inform public health recommendations for food packaging and provide much needed experimental evidence as to whether BPA poses any public health risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants consume Vanilla Wafer cookie |
| BPA 4 ug/kg BW | Experimental | Other: BPA 4 ug/kg BWParticipants consume 4 ug/kg BW of BPA on a Vanilla Wafer Cookie |
| BPA 50 ug/kg BW | Experimental | Other: BPA 50 ug/kg BWParticipants consume 50 ug/kg BW of BPA on a Vanilla Wafer Cookie |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI = 18.5-35
- Age 18-50 years
- Non-smoking
- English speaking
Key exclusion criteria (8 listed)
- History of infertility
- Type 2 or Type 1 diabetes
- Cardiovascular disease, or any other metabolic disease/complication
- Hypertension (systolic blood pressure ≥140, diastolic blood pressure ≥90) assessed by sphygmomanometer
- History of major psychiatric illness, drug abuse, or unsafe dieting practices
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 |
|---|---|---|
| PlaceboIngestion of Placebo | Other | Placebo |
| BPA 4 ug/kg BWOral BPA ingestion of 4 ug/kg BW | Other | BPA 4 ug/kg BW |
| BPA 50 ug/kg BWOral BPA ingestion of 50 ug/kg BW | Other | BPA 50 ug/kg BW |
Primary outcome
Change From Baseline Glucose at 180 Minutes
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Glucose concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test
5 secondary outcomes
Change From Baseline Insulin at 180 Minutes
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline Estrogen at 180 Minutes
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline C-Peptde at 180 Minutes
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline Pro-Insulin at 180 Minutes
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
Change From Baseline Triglycerides at 180 Minutes
Time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180
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 18 Feb 2019.
- Individual participant dataSharing planned: No. No plan to share data in this pilot study
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPA 4 ug/kg BW and BPA 50 ug/kg BW in people with Environmental Exposure, 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 4 inclusion and 8 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 18 Feb 2019. 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 From Baseline Glucose at 180 Minutes (time frame: 9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180). 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 18 Feb 2019.