Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic session, HIIT session.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type I, Menstruation. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes (DIABETEXX/2)
Overview
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.
Interventions
- Other Aerobic session
This session will consist of an aerobic training session performed on a cycle ergometer. - Other HIIT session
The HIIT exercise will consist of strength exercises with elastic bands.
Primary outcome measures
- Mean interstitial glucose [Time frame: 24 hours pre-intervention and 24 hours post-intervention]
- Glycemic variability [Time frame: 24 hours pre-intervention and 24 hours post-intervention]
- Time spent at each glucose range [Time frame: 24 hours pre-intervention and 24 hours post-intervention]
Secondary outcome measures (2)
- Oestrogens [Time frame: pre-intervention]
- Progesterone [Time frame: Pre-intervention]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Spain · 1 center
- University of Valencia — Valencia
Identifiers
NCT: NCT06729242 · 2024.228 · PID2022-137723OB-C21