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

NCT06086067 | Completed

• 1 other identifier: 1586990
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

aerobic; woman; glucemic

Outcome Measures

Primary Outcomes (4)

• Blood glucose level

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

  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.

• 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.

  24 hours pre-intervention and 24 hours post-intervention

• 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.

  24 hours pre-intervention and 24 hours post-intervention

• 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.

  24 hours pre-intervention and 24 hours post-intervention

Secondary Outcomes (3)

• Lactate

  pre-intervention and immediately after the intervention

• Oestrogens

  pre-intervention

• Progesterone

  pre-intervention

Study Arms (2)

Aerobic session in luteal phase

EXPERIMENTAL

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. This session will be held on day 21 of menstruation.

Other: Aerobic session

Aerobic session in follicular phase

EXPERIMENTAL

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. This session will be held on day 3 of menstruation.

Other: Aerobic session

Interventions

Aerobic session OTHER

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

Aerobic session in follicular phase; Aerobic session in luteal phase

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).

Sponsors & Collaborators

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

Study Sites (1)

Rodrigo Martin-San Agustin

Valencia, Spain

Location

Related Publications (1)

• Cuerda-Del Pino A, Laguna Sanz AJ, Diez JL, Rossetti P, Marco Romero C, Ampudia-Blasco FJ, Bondia J, Martin-San Agustin R. Accuracy of FreeStyle Libre 3 During Moderate-Intensity Continuous Aerobic Exercise at Different Phases of the Menstrual Cycle in Females with Type 1 Diabetes. Diabetes Technol Ther. 2025 Sep;27(9):687-695. doi: 10.1089/dia.2024.0558. Epub 2025 Apr 17.

  PMID: 40256792 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 17, 2023
• Study Start: September 15, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)