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Completed

NCT Number: NCT06086067

Influence of the Phases of the Menstrual Cycle on Glycemic Control When Performing Aerobic Exercise in Women With T1D

This study corresponds to Task 8.1 of the project "Patient-tailored solutions for blood glucose control in type 1 diabetes- TAILOR" (PID2019-107722RB-C21).

It has been observed in different studies in healthy people that the glucose rate of appearance or disappearance during exercise is attenuated with the coincident rise in estrogen and progesterone during the mid-luteal phase of the menstrual cycle versus the early luteal phase.

The investigators hypothesize that in women with type 1 diabetes, glucose behavior when performing aerobic exercise may be different depending on the phase of the menstruation cycle. This analysis is necessary to improve physical exercise recommendations, both educational and technological, in women with type 1 diabetes, as well as improve the performance of artificial pancreas systems for automatic control of glucose levels under exercise in women.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rodrigo Martin-San Agustin

Valencia, Spain

About this study

This study will consist of two aerobic exercise sessions, one conducted at the beginning of the late follicular phase, where maximal estrogen concentration coincides with low progesterone levels, and the other session in the middle of the luteal phase, where peak values of estrogen and progesterone are generally observed.

Prior to the exercise sessions, an incremental exercise test will be performed to determine the working power in the cycle ergometer. At the beginning of the test, subjects will be sit quietly on the cycle ergometer for 3 min (0 W) before they will start the warm-up period of 3 min with cycling at a workload of 40 W. Then, the workload will increase by 20 W every minute until volitional exhaustion. Finally, 3 min active recovery at 40 W followed by 3 min passive recovery (0 W) will be conducted on the cycle ergometer. Lactate turn point 1 (LTP1) and maximum power (Pmax) will be determined in order to prescribe the exercise intensity.

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.

To monitor the impact on blood glucose, blood draws will be performed at initial and every 10 minutes for aerobic sessions. A sample size of n=30 will be chosen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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).

Treatment and study plan

Aerobic session

Other

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

Primary outcomes

  1. Blood glucose level

    Time frame: The evaluated time points for aerobic exercise will be at 20 and 10 minutes before the session, at the beginning of the training and at 10, 20, and 30 minutes during the interval, and at 10 and 20 minutes after finishing the training.

    Blood glucose (mg/dL) will be measured through blood draws and YSI analysis

  2. Mean interstitial glucose

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

    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.

  3. Glycemic variability

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

    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.

  4. Time spent at each glucose range

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

    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.

Secondary outcomes

  1. Lactate

    Time frame: pre-intervention and immediately after the intervention

    Lactate concentration (mmol/L) will be performed through blood extractions and measured using the YSI 2500.

  2. Oestrogens

    Time frame: pre-intervention

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

  3. Progesterone

    Time frame: pre-intervention

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

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)
  • European Regional Development Fund
  • Ministerio de Ciencia e Innovación, Spain
  • Universitat Politècnica de València

Registry information

Official study title

Influence of the Phases of the Menstrual Cycle on Glycemic Control Before, During, and After a Aerobic Exercise in Adult Women With Type 1 Diabetes (TAILOR/1a)

Acronym: TAILOR/1a

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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