Actively Recruiting
Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes (DIABETEXX/2)
Led by University of Valencia · Updated on 2025-07-08
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Valencia
Lead Sponsor
E
European Regional Development Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how blood glucose levels change during different phases of the menstrual cycle in adult women with type 1 diabetes, especially during aerobic or high-intensity interval training (HIIT) exercise. The goal is to understand whether glucose behaves differently depending on the menstrual phase and use this knowledge to develop better exercise guidelines and improve artificial pancreas systems for women. The study involves aerobic exercise sessions on a cycle ergometer and HIIT sessions using strength exercises with elastic bands. Aerobic sessions include a resting period, warm-up, and stepwise intensity increase to a moderate steady state, maintained for 30 minutes, with recovery periods. These sessions occur on specific days of the menstrual cycle (day 3 or day 21). HIIT sessions consist of two sets of 20-second exercise intervals separated by rests and are also scheduled on specific menstrual cycle days. Participants will be monitored for blood glucose levels 24 hours before and after exercise, measuring mean glucose, variability, and time spent at different glucose ranges. Hormone levels such as oestrogens and progesterone will be assessed before exercise. The study is randomized and open-label, with researchers tracking responses to exercise across menstrual phases. The study runs from January 2025 to June 2026 and is sponsored by the University of Valencia.
CONDITIONS
Brief Title
Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged between 18 and 45 years
- Diagnosed with type 1 diabetes for more than 2 years
- Glycated hemoglobin (HbA1c) less than 8.5% (less than 69 mmol/mol)
- Stable insulin regimen for the past 6 months with less than 20% change in daily insulin dose
- Using multiple daily insulin injections or an insulin pump
- Engaging in at least 90 minutes of physical activity weekly but not practicing any sport as amateur or professional
You will not qualify if you...
- Having clinical conditions or using medications other than insulin that affect blood sugar control (e.g., oral or injected steroids, metformin, among others)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Across two menstrual cycles
Participants complete aerobic and HIIT exercise sessions scheduled according to menstrual cycle phases to study their effects on glycemic control.
6 exercise sessions timed on specific days of menstrual cycles
Duration - 48 hours around each intervention session
Participants' glucose levels and hormone levels are monitored before and after each exercise session.
Continuous glucose monitoring and pre-intervention blood tests for hormones
Trial Site Locations
Total: 1 location
1
University of Valencia
Valencia, Select One, Spain, 46010
Actively Recruiting
Research Team
R
Rodrigo Martín-San Agustín, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
6
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