Clinical trial NCT06086067: Influence of the Phases of the Menstrual Cycle on Glycemic Control When Performing Aerobic Exercise in Women With T1D
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: aerobic
woman
glucemic
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
name: Ministerio de Ciencia e Innovación, Spain
name: European Regional Development Fund
name: Universitat Politècnica de València
First posted: 2023-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two interventions will be carried out in a single group, being two aerobic sessions, one in luteal phase and another in follicular phase. Because we want to observe both phases in the same menstruation cycle, both aerobic training sessions cannot be randomized.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

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
* 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).

Primary outcomes:
measure: Blood glucose level
timeFrame: 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.
measure: Mean interstitial glucose
timeFrame: 24 hours pre-intervention and 24 hours post-intervention
measure: Glycemic variability
timeFrame: 24 hours pre-intervention and 24 hours post-intervention
measure: Time spent at each glucose range
timeFrame: 24 hours pre-intervention and 24 hours post-intervention
Secondary outcomes:
measure: Lactate
timeFrame: pre-intervention and immediately after the intervention
measure: Oestrogens
timeFrame: pre-intervention
measure: Progesterone
timeFrame: pre-intervention
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Rodrigo Martin-San Agustin
Study officials:
References: