Influence of the Phases of the Menstrual Cycle on Glycemic Control Before, During, and After a Aerobic Exercise in Adult Women With Type 1 Diabetes (TAILOR/1a)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time spent at each glucose range
研究概览
简要总结
This study corresponds to Task 8.1 of the project "Patient-tailored solutions for blood glucose control in type 1 diabetes- TAILOR" (PID2019-107722RB-C21).
It has been observed in different studies in healthy people that the glucose rate of appearance or disappearance during exercise is attenuated with the coincident rise in estrogen and progesterone during the mid-luteal phase of the menstrual cycle versus the early luteal phase.
The investigators hypothesize that in women with type 1 diabetes, glucose behavior when performing aerobic exercise may be different depending on the phase of the menstruation cycle. This analysis is necessary to improve physical exercise recommendations, both educational and technological, in women with type 1 diabetes, as well as improve the performance of artificial pancreas systems for automatic control of glucose levels under exercise in women.
详细描述
This study will consist of two aerobic exercise sessions, one conducted at the beginning of the late follicular phase, where maximal estrogen concentration coincides with low progesterone levels, and the other session in the middle of the luteal phase, where peak values of estrogen and progesterone are generally observed.
Prior to the exercise sessions, an incremental exercise test will be performed to determine the working power in the cycle ergometer. At the beginning of the test, subjects will be sit quietly on the cycle ergometer for 3 min (0 W) before they will start the warm-up period of 3 min with cycling at a workload of 40 W. Then, the workload will increase by 20 W every minute until volitional exhaustion. Finally, 3 min active recovery at 40 W followed by 3 min passive recovery (0 W) will be conducted on the cycle ergometer. Lactate turn point 1 (LTP1) and maximum power (Pmax) will be determined in order to prescribe the exercise intensity.
The aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 40 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test.
To monitor the impact on blood glucose, blood draws will be performed at initial and every 10 minutes for aerobic sessions. A sample size of n=30 will be chosen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).
结局指标
主要结局
Time spent at each glucose range
时间窗: 24 hours pre-intervention and 24 hours post-intervention
Time spent at each glucose range \[euglycemia (70-180 mg/dL) or Time in range (TIR), level 1 or mild hypoglycemia (54-70 mg/dL), level 2 or severe hypoglycemia (\<54 mg/dL), level 1 hyperglycemia (180-250 mg/dL) and level 2 hyperglycemia (\>250 mg/dL)\] will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions.
Glycemic variability
时间窗: 24 hours pre-intervention and 24 hours post-intervention
Glycemic variability (measured using the Coefficient of Variation-CV) will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions.
Blood glucose level
时间窗: The evaluated time points for aerobic exercise will be at 20 and 10 minutes before the session, at the beginning of the training and at 10, 20, and 30 minutes during the interval, and at 10 and 20 minutes after finishing the training.
Blood glucose (mg/dL) will be measured through blood draws and YSI analysis
Mean interstitial glucose
时间窗: 24 hours pre-intervention and 24 hours post-intervention
Mean interstitial glucose (mg/dL) will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions.
次要结局
- Lactate(pre-intervention and immediately after the intervention)
- Oestrogens(pre-intervention)
- Progesterone(pre-intervention)
研究者
Rodrigo Martín-San-Agustin
Professor
University of Valencia