The Effect of High-Intensity Short-Duration Exercise Versus Moderate-Intensity High-Volume Exercise on Glucose Control as Measured by Continuous Glucose Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Mean Glucose Concentration
研究概览
简要总结
This study will be conducted as a prospective, randomized crossover trial evaluating non-diabetic and pre-diabetic adults ($n=12$) continuously monitored with Dexcom G7 continuous glucose monitors over an 11-day period. Participants will complete two distinct exercise protocols in a randomized sequence: five consecutive days of Zone 2 aerobic exercise and a single session of high-intensity interval training (HIIT). Primary outcome metrics will focus on mean glucose levels and time in range (TIR, defined as $\le 120\text{ mg/dL}$) recorded throughout each active exercise block and its associated recovery window. To evaluate the comparative efficacy of the two modalities, paired within-subject differences will be statistically analyzed against pre-specified non-inferiority margins set at $3\text{ mg/dL}$ for mean glucose, as well as a primary $3$-point and secondary $5$-point margin for time in range.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Age 18 years or older. Non-diabetic or pre-diabetic status (defined by medical history or standard screening criteria, e.g., HbA1c < 6.5%).
- •Capable and willing to participate in both Zone 2 aerobic exercise and high-intensity interval training (HIIT) protocols.
- •Willing to wear a continuous glucose monitor (Dexcom G7) continuously for the 11-day study duration.
- •Able to provide written informed consent.
排除标准
- •Diagnosis of Type 1 or Type 2 diabetes. Use of glucose-lowering medications, insulin, or other pharmaceuticals that significantly alter glucose metabolism.
- •Current skin conditions, allergies, or sensitivities to medical-grade adhesives that prevent continuous glucose monitor placement.
- •Musculoskeletal, cardiovascular, or neurological conditions that contraindicate vigorous exercise or high-intensity interval training.
- •Pregnant or planning to become pregnant during the study period. Concurrent participation in another clinical trial or interventional exercise study.
研究组 & 干预措施
Moderate Intensity Exercise
Five consecutive days of moderate intensity aerobic exercise
干预措施: Moderate Intensity aerobic training (Other)
High Intensity Exercise
One session High-Intensity Interval training
干预措施: High Intensity Interval Training (Other)
结局指标
主要结局
Mean Glucose Concentration
时间窗: Measured continuously over each 5-day exercise/recovery block within the 11-day monitoring period.
Average glucose level recorded by continuous glucose monitor (CGM) across the exercise intervention block and its subsequent recovery window.
Time in Range (TIR)
时间窗: Measured continuously over each 5-day exercise/recovery block within the 11-day monitoring period.
Percentage of time spent with sensor glucose values under 120mg/dL during the active exercise block and its recovery window.
次要结局
未报告次要终点