Glucose Metabolism Disorders, Insulin Sensitivity, Microtia
Conditions
Keywords
bisphenol A, diet
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).
Interventions
BEHAVIORALbisphenol A
Vanilla wafer cookie with bisphenol A administered
BEHAVIORALPlacebo
Vanilla wafer cookie with no bisphenol A
Sponsors
American Diabetes Association
California Polytechnic State University-San Luis Obispo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This study will be a double-blinded study. Research staff collecting data and participants will not know treatment allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in rate of glucose disposal | 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 | Baseline and 4 days | Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in concentration of c-peptide | Baseline and 4 days | Fasting blood sample for c-peptide concentration |
| Change in concentration of proinsulin | Baseline and 4 days | Fasting blood sample for proinsulin |
| Change in concentration of adiponectin | Baseline and 4 days | Fasting blood sample for adiponectin |
| Change in concentration of insulin | Baseline and 4 days | Fasting blood sample for insulin concentration |
| Change in concentration of firmicutes | Baseline and 4 days | Fecal microbiome concentration of firmicutes |
| Change in concentration of clostridia | Baseline and 4 days | Fecal microbiome concentration of clostridia |
| Change in concentration of 17-beta estradiol | Baseline and 4 days | Fasting blood sample for 17-beta estradiol |
| Change in concentration of glucose | Baseline and 4 days | Fasting blood sample for glucose concentration |
Countries
United States
Outcome results
None listed