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

NCT ID: NCT06729242

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Diabetes Mellitus, Type I; Menstruation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Aerobic session in luteal phase first menstruation

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.

Group Type: EXPERIMENTAL

Aerobic session

Intervention Type: OTHER

This session will consist of an aerobic training session performed on a cycle ergometer.

Aerobic session in follicular phase first menstruation

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.

Group Type: EXPERIMENTAL

Aerobic session

Intervention Type: OTHER

This session will consist of an aerobic training session performed on a cycle ergometer.

Aerobic session in luteal phase second menstruation

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.

Group Type: EXPERIMENTAL

Aerobic session

Intervention Type: OTHER

This session will consist of an aerobic training session performed on a cycle ergometer.

HIIT session in luteal phase first menstruation

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.

Group Type: EXPERIMENTAL

HIIT session

Intervention Type: OTHER

The HIIT exercise will consist of strength exercises with elastic bands.

HIIT session in follicular phase first menstruation

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.

Group Type: EXPERIMENTAL

HIIT session

Intervention Type: OTHER

The HIIT exercise will consist of strength exercises with elastic bands.

HIIT session in luteal phase second menstruation

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.

Group Type: EXPERIMENTAL

HIIT session

Intervention Type: OTHER

The HIIT exercise will consist of strength exercises with elastic bands.

Interventions

Aerobic session

This session will consist of an aerobic training session performed on a cycle ergometer.

Intervention Type: OTHER

HIIT session

The HIIT exercise will consist of strength exercises with elastic bands.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Regional Development Fund

OTHER

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Martín-San-Agustin

Assistant Professor of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Valencia

Valencia, Select One, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Rodrigo Martín-San Agustín, Dr.

Role: CONTACT

rodrigo.martin@uv.es

0034963983855

Facility Contacts

Rodrigo

Role: primary

rodrigo.martin@uv.es

963983855

Other Identifiers

PID2022-137723OB-C21

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024.228

Identifier Type: -

Identifier Source: org_study_id