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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet plus bisphenol A | Experimental | Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight. |
|
| Placebo | Placebo Comparator | Participants will receive a 4-day diet plus no bisphenol A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bisphenol A | Behavioral | Vanilla wafer cookie with bisphenol A administered |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in rate of glucose appearance | Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance | Baseline and 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of insulin | Fasting blood sample for insulin concentration | Baseline and 4 days |
| Change in concentration of glucose | Fasting blood sample for glucose concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Hagobian, PhD | California Polytechnic State University-San Luis Obispo | Principal Investigator |
| Hannah Brunner-Gaydos | California Polytechnic State University-San Luis Obispo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Polytechnic State University | San Luis Obispo | California | 93405 | United States |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion, and will be available indefinitely.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 1, 2019 | Nov 8, 2019 | Prot_SAP_ICF_003.pdf |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D044882 | Glucose Metabolism Disorders |
| D065817 | Congenital Microtia |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004427 | Ear Diseases |
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| ID | Term |
|---|---|
| C006780 | bisphenol A |
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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.
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This study will be a double-blinded study. Research staff collecting data and participants will not know treatment allocation.
| Placebo |
| Behavioral |
Vanilla wafer cookie with no bisphenol A |
|
| Baseline and 4 days |
| Change in concentration of c-peptide | Fasting blood sample for c-peptide concentration | Baseline and 4 days |
| Change in concentration of proinsulin | Fasting blood sample for proinsulin | Baseline and 4 days |
| Change in concentration of adiponectin | Fasting blood sample for adiponectin | Baseline and 4 days |
| Change in concentration of 17-beta estradiol | Fasting blood sample for 17-beta estradiol | Baseline and 4 days |
| Change in concentration of firmicutes | Fecal microbiome concentration of firmicutes | Baseline and 4 days |
| Change in concentration of clostridia | Fecal microbiome concentration of clostridia | Baseline and 4 days |
| D010038 |
| Otorhinolaryngologic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |