Randomized Trial Examining Oral Consumption of Bisphenol A on Type 2 Diabetes Risk Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in rate of glucose disposal
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study will be a double-blinded study. Research staff collecting data and participants will not know treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •special diets (e.g. vegetarian, low-carbohydrate, Paleolithic, etc.)
- •pregnant women or women trying to become pregnant
结局指标
主要结局
Change in rate of glucose disposal
时间窗: 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
时间窗: Baseline and 4 days
Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance
次要结局
- Change in concentration of c-peptide(Baseline and 4 days)
- Change in concentration of 17-beta estradiol(Baseline and 4 days)
- Change in concentration of glucose(Baseline and 4 days)
- Change in concentration of insulin(Baseline and 4 days)
- Change in concentration of proinsulin(Baseline and 4 days)
- Change in concentration of clostridia(Baseline and 4 days)
- Change in concentration of adiponectin(Baseline and 4 days)
- Change in concentration of firmicutes(Baseline and 4 days)
研究者
Todd Hagobian
Associate Professor
California Polytechnic State University-San Luis Obispo