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临床试验/NCT04309071
NCT04309071Unknown不适用

Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

University of British Columbia2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年1月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Saliva insulin at different time points

研究概览

简要总结

Recent evidence suggests that hyperinsulinemia (i.e., elevated insulin levels) is the primary causative factor in obesity. Insulin promotes fat storage and prevents fat breakdown, suggesting that weight loss would be optimized if insulin levels are managed and kept low. Understanding how different foods impact insulin levels could therefore aid in personalized weight loss (or weight maintenance) advice. It has been shown that salivary insulin can track plasma insulin following different meals and can delineate between lean and obese people. Thus, it was suggested that salivary insulin could be a potential surrogate for plasma insulin. The purpose of this study is to measure fasting saliva insulin, and salivary insulin responses to a standardized meal tolerance test in individuals with different body mass index (BMI).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non-smoker
  • have a body mass index greater than 18.5 kg/m2
  • have not been diagnosed with type 2 diabetes or other medical conditions affecting glucose or insulin levels

排除标准

  • You have been. diagnosed with diabetes (fasting blood sugar more than 7.0 mmol/l) or any other diagnosed chronic condition that may impact your glucose or insulin levels or the outcomes of this study.
  • You take any medication which may affect your glucose and insulin level
  • Unable to travel to make your testing appointments.
  • Unable to consume the meal tolerance test drink/shake and/or provide finger stick glucose or saliva samples for the study.

结局指标

主要结局

Saliva insulin at different time points

时间窗: Salivary insulin at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)

Saliva insulin will be collected and measured by enzyme-linked immunosorbent assay.

Saliva insulin area under the curve

时间窗: Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)

The saliva insulin concentration measured by enzyme-linked immunosorbent assay - Area under the curve will be measured using the trapezoidal rule.

次要结局

  • Glucose(Finger prick glucose will be measured at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion))
  • Glucose area under the curve(Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Little

Associate Professor

University of British Columbia

研究点 (2)

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