Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes (DIABETEXX/2)

University of Valencia

Status: Enrolling

Conditions: Menstruation; Diabetes Mellitus, Type I

Treatments: Other: HIIT session; Other: Aerobic session

Study type: Interventional

Funder types: Other

Identifiers

NCT06729242

2024.228

PID2022-137723OB-C21 (Other Grant/Funding Number)

Details and patient eligibility

About

Continuous glucose monitors, as a technology that aims to improve glycaemic control in patients with type 1 diabetes, must always adjust to changes in blood glucose levels in these patients, e.g. during sporting activities. In women, in particular, menstruation and its different phases can affect blood glucose levels in different ways. Therefore, this study aims to determine whether there is a different behaviour of blood glucose levels during aerobic or high-intensity exercise in different phases of menstruation. If so, we will try to model this behaviour and create specific guidelines in this regard in terms of physical exercise programming in women. In addition, the information derived from this study will be used to design better artificial pancreas systems that take into account the effects of the menstrual cycle in women.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age between 18-45 years T1D with a diabetes duration for more than 2 years Glycated hemoglobin (HbA1c) < 8.5% (<69 mmol mol-1) Stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose Multiple daily injections or insulin pump Weekly physical activity of 90 min or more, but no practicing any sport as amateur or professional.

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 6 patient groups

Aerobic session in luteal phase first menstruation

Experimental group

Description:

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 first menstruation.

Treatment:

Other: Aerobic session

Aerobic session in follicular phase first menstruation

Experimental group

Description:

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.

Treatment:

Other: Aerobic session

Aerobic session in luteal phase second menstruation

Experimental group

Description:

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 second menstruation.

Treatment:

Other: Aerobic session

HIIT session in luteal phase first menstruation

Experimental group

Description:

The HIIT exercise will consist of strength exercises with elastic bands. The session consists of two sets of exercise intervals of 20 s separated by 10 s of rest (i.e. 4 min in total) with a rest of 3 minutes between each set, performing in each interval a different exercise resisted by the elastic band. This session will be held on day 21 of first menstruation.

Treatment:

Other: HIIT session

HIIT session in follicular phase first menstruation

Experimental group

Description:

The HIIT exercise will consist of strength exercises with elastic bands. The session consists of two sets of exercise intervals of 20 s separated by 10 s of rest (i.e. 4 min in total) with a rest of 3 minutes between each set, performing in each interval a different exercise resisted by the elastic band. This session will be held on day 3 of first menstruation.

Treatment:

Other: HIIT session

HIIT session in luteal phase second menstruation

Experimental group

Description:

The HIIT exercise will consist of strength exercises with elastic bands. The session consists of two sets of exercise intervals of 20 s separated by 10 s of rest (i.e. 4 min in total) with a rest of 3 minutes between each set, performing in each interval a different exercise resisted by the elastic band. This session will be held on day 21 of second menstruation.

Treatment:

Other: HIIT session