Glycemic Effects of Meals - Repeatability Trial With Continuous Glucose Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Glycemic patterns from CGM
研究概览
简要总结
Almost half of adults in the United States have either diabetes mellitus (DM) or prediabetes (preDM), but many are undiagnosed and unaware of their condition. Current DM diagnosis and risk prediction are based on single "snapshot" measurements including: fasting blood glucose, postprandial glucose, and hemoglobin (Hb)A1c. Continuous glucose monitoring (CGM) offers a dynamic view of glucose levels throughout the day which enables characterizing individuals' dynamic glycemic profiles in response to physiological and environmental stimuli better than the conventional point-in-time glucose quantification approaches. By analyzing glycemic patterns from CGM tracings, it may be possible to identify individuals at increased risk of developing diabetes. However, an important prerequisite is to establish the reliability and consistency of glucose response patterns captured by CGM under controlled conditions.
Participants will be given six different meals to examine the glucose responses to these meals. Two of these meals (white rice and an Ensure drink) will be given twice for each participant to investigate whether individuals have the same glucose response to the same meal given on different days. Glucose will be measured using continuous glucose monitors, that have a thin wire sensor that measures glucose under the skin every five minutes for up to 10 days.
详细描述
This is a pilot study in which each participant undergoes six meal challenges (one each morning) under free-living conditions, while wearing a blinded CGM sensor. Glucose levels will be continuously measured, and meal challenge sequence will be randomly assigned to each participant.
The study objectives are to:
- determine the within meal replicability of postprandial glucose response to a Ensure and White Rice meal challenges
- evaluate if a whole food meal challenge (White Rice) exhibits lower reliability and greater physiological variability (under the chewing vs. not chewing condition) in postprandial glucose response compared to a standardized liquid mixed meal tolerance test (Ensure)
- compare the postprandial average peak glucose response and 4 hour incremental area under the curve (iAUC) for the Ensure tolerance test, mountain dew tolerance test, White Rice, and typical breakfast.
These findings will inform the design of future studies and the potential use of CGM-based dietary challenges for early detection of metabolic risk.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •English speaking
排除标准
- •Prior diagnosis of diabetes or taking medications that influence glucose metabolism, such as insulin, glucocorticoids, or Glucagon-like peptide-1 (GLP-1) receptor agonists.
- •Taking hydroxyurea medication
- •Taking beyond the maximum dose of acetaminophen (4g/day)
- •Known food allergies or severe sensitivities to any study materials (dairy or soy)
- •Limited and non-readers
- •Cognitive impairment
研究组 & 干预措施
Continuous glucose monitoring
Each participant will have a Dexcom G6 CGM sensor applied to the upper arm. The order of the six study meals will be randomly assigned.
干预措施: Six meal challenges (Other)
结局指标
主要结局
Glycemic patterns from CGM
时间窗: baseline, every 4 hours for 6 days
Beginning at baseline, a 4-hour incremental area under the glucose curve (iAUC) will be calculated using the trapezoidal method. Peak glucose will be defined as the maximum glucose excursion within the 4-hour window. Continuous glucose monitoring (CGM) CGM values are recorded every 5 minutes, so linear interpolation will be used to provide a CGM value every minute to line up with the ingestion time documented in the participant's log.
次要结局
- Fasting blood glucose levels(baseline, daily for 6 days)
- Post prandial glucose levels(baseline, daily for 6 days)