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临床试验/NCT03444922
NCT03444922已完成不适用

Effects of Oral Ingestion of BPA on Insulin and Glucose Responses

California Polytechnic State University-San Luis Obispo2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
Change From Baseline Glucose at 180 Minutes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Double-blinded study; Study statistician computer generated randomization

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI = 18.5-35
  • Age 18-50 years
  • Non-smoking
  • English speaking

排除标准

  • 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

研究组 & 干预措施

Placebo

Placebo Comparator

Participants consume Vanilla Wafer cookie

干预措施: Placebo (Other)

BPA 4 ug/kg BW

Experimental

Participants consume 4 ug/kg BW of BPA on a Vanilla Wafer Cookie

干预措施: BPA 4 ug/kg BW (Other)

BPA 50 ug/kg BW

Experimental

Participants consume 50 ug/kg BW of BPA on a Vanilla Wafer Cookie

干预措施: BPA 50 ug/kg BW (Other)

结局指标

主要结局

Change From Baseline Glucose at 180 Minutes

时间窗: 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

次要结局

  • Change From Baseline Pro-Insulin at 180 Minutes(9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180)
  • Change From Baseline Insulin at 180 Minutes(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(9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180)
  • Change From Baseline Triglycerides at 180 Minutes(9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180)
  • Change From Baseline Estrogen at 180 Minutes(9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180)

研究者

发起方
California Polytechnic State University-San Luis Obispo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Todd Hagobian

Associate Professor

California Polytechnic State University-San Luis Obispo

研究点 (2)

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