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

ConditionsDiabetes Mellitus, Type IMenstruation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Valencia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Aerobic session

    Other intervention

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

  • HIIT session

    Other intervention

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

Treatment groups

40 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Aerobic session in luteal phase first menstruationExperimental treatment 1 intervention
Group B: Aerobic session in follicular phase first menstruationExperimental treatment 1 intervention
Group C: Aerobic session in luteal phase second menstruationExperimental treatment 1 intervention
Group D: HIIT session in luteal phase first menstruationExperimental treatment 1 intervention
Group E: HIIT session in follicular phase first menstruationExperimental treatment 1 intervention
Group F: HIIT session in luteal phase second menstruationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours pre-intervention and 24 hours post-intervention
2

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.

Time frame
24 hours pre-intervention and 24 hours post-intervention
3

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.

Time frame
24 hours pre-intervention and 24 hours post-intervention

Secondary outcomes

1

Oestrogens

Estradiol levels (pg/ml) will be measured through blood extractions and subsequent analysis in the laboratory.

Time frame
pre-intervention
2

Progesterone

Progesterone (ng/mL) will be measured through blood extractions and subsequent analysis in the laboratory.

Time frame
Pre-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Valencia

Lead sponsor

European Regional Development Fund

Collaborator

Source ClinicalTrials.gov
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