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

NCT06729242 | Recruiting

• 2 other identifiers: 2024.228PID2022-137723OB-C21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  24 hours pre-intervention and 24 hours post-intervention

Secondary Outcomes (2)

• Oestrogens

  pre-intervention

• Progesterone

  Pre-intervention

Study Arms (6)

Aerobic session in luteal phase first menstruation

EXPERIMENTAL

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.

Other: Aerobic session

Aerobic session in follicular phase first menstruation

EXPERIMENTAL

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

Aerobic session in luteal phase second menstruation

EXPERIMENTAL

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.

Other: Aerobic session

HIIT session in luteal phase first menstruation

EXPERIMENTAL

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.

Other: HIIT session

HIIT session in follicular phase first menstruation

EXPERIMENTAL

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.

Other: HIIT session

HIIT session in luteal phase second menstruation

EXPERIMENTAL

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.

Other: HIIT session

Interventions

Aerobic session OTHER

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

Aerobic session in follicular phase first menstruation; Aerobic session in luteal phase first menstruation; Aerobic session in luteal phase second menstruation

HIIT session OTHER

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

HIIT session in follicular phase first menstruation; HIIT session in luteal phase first menstruation; HIIT session in luteal phase second menstruation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).

Sponsors & Collaborators

• University of Valencia: lead
• European Regional Development Fund: collaborator

Study Sites (1)

University of Valencia

Valencia, Select One, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Rodrigo Martín-San Agustín, Dr.

CONTACT

0034963983855; rodrigo.martin@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy

Model Details: Six interventions will be carried out in a single group, being three aerobic sessions, two in two luteal phases and another in follicular phase, and other three session of high intensity interval exercise (HIIT).

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 11, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)