The Impact of Food Order/Nutrient Sequence on Glycemic Excursions in Type 2 Diabetes Assessed by Continuous Glucose Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in incremental glucose peak, under controlled conditions
研究概览
简要总结
The purpose of this study is to explain the effect of food order/nutrient sequencing on glycemic excursions over a 2 week period, utilizing a device known as a continuous glucose monitor (CGM), for people who have been diagnosed with Type 2 Diabetes Mellitus and treated with metformin. This research study is being done because recent studies demonstrate that besides carbohydrate amount and type, the sequential order of macronutrient consumption during a meal has a significant impact on post-meal glucose levels.
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 (Participant)
盲法说明
Participants will be blinded to continuous glucose monitoring readings.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metformin-treated type 2 diabetes of less than 10 years duration
- •Must be on a stable dose of metformin for at least 1 month
- •HbA1c ≤8.5 percent
排除标准
- •Relevant food allergies
- •Oral steroid therapy within 90 days of enrollment
- •Anti-diabetic medications other than metformin
- •History of bariatric surgery
- •Pregnant women
- •Any participant deemed unsuitable in the investigator's opinion
结局指标
主要结局
Change in incremental glucose peak, under controlled conditions
时间窗: Day 6, Day 12
Change in mean amplitude of glycemic excursion, under controlled conditions
时间窗: Day 6, Day 12
Change in time in range, under controlled conditions
时间窗: Day 6, Day 12
Time during which participant maintained a blood glucose level between 70-180mg/dL over 8 hour observation period
次要结局
- Change in incremental glucose peak, under free-living conditions(Day 1 through 5, Day 7 through 11)
- Change in postprandial GLP-1 concentration(Day 6, Day 12)
- Change in postprandial insulin concentration(Day 6, Day 12)
- Change in mean amplitude of glycemic excursion, under free-living conditions(Day 1 through 5, Day 7 through 11)
- Change in postprandial c-peptide concentration(Day 6, Day 12)
- Change in time in range, under free-living conditions(Day 1 through 5, Day 7 through 11)
- Change in postprandial ghrelin concentration(Day 6, Day 12)
- Change in satiety, as measured by Visual Analog Scale (VAS)(Day 6, Day 12)
- Change in postprandial PYY concentration(Day 6, Day 12)
- Change in postprandial CCK concentration(Day 6, Day 12)