An interventional study of Aerobic session in Diabetes Mellitus, Type 1, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by University of Valencia · Not applicable, Interventional, and Health services research
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.
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Exclusion Criteria:
-clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).
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. This session will be held on day 21 of menstruation.
Other: Aerobic session
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. This session will be held on day 3 of menstruation.
Other: Aerobic session
This session will consist of an aerobic training session performed on a cycle ergometer.
Blood glucose level
Blood glucose (mg/dL) will be measured through blood draws and YSI analysis
Time frame: 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.
Mean interstitial glucose
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.
Time frame: 24 hours pre-intervention and 24 hours post-intervention
Glycemic variability
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.
Time frame: 24 hours pre-intervention and 24 hours post-intervention
Time spent at each glucose range
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.
Time frame: 24 hours pre-intervention and 24 hours post-intervention
Lactate
Lactate concentration (mmol/L) will be performed through blood extractions and measured using the YSI 2500.
Time frame: pre-intervention and immediately after the intervention
Oestrogens
estradiol levels (pg/ml) will be measured through blood extractions and subsequent analysis in the laboratory.
Time frame: pre-intervention
Progesterone
Progesterone (ng/mL) will be measured through blood extractions and subsequent analysis in the laboratory.
Time frame: pre-intervention
Plan to share: No
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University of Valencia