Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05188014

Exercise and the Menstrual Cycle in Type 1 Diabetes

Female participants with type 1 diabetes using oral contraceptives will be asked to wear a continuous glucose monitor for at least three days on two separate occasions (once during the last week of active pills and once during the no pill/placebo pill phase of the menstrual cycle). An exercise session (45 minutes of aerobic exercise at 60% VO2peak on a cycle ergometer) will take place at 5 pm on the second day of glucose monitoring.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2R3, Canada

Location status: Recruiting

Location contact

Jane E Yardley, PhD

CONTACT

[email protected]

7806791688

About this study

Pre-test measures: Interested participants will be invited to the Physical Activity and Diabetes Laboratory on the main campus of the University of Alberta. They will be asked questions related to their menstrual cycle, physical activity levels and medication. Blood pressure will also be measured to assess their eligibility. Where participants are eligible, anthropometric characteristics will be measured using standard protocols. A blood sample will be drawn for assessment of HbA1c. Participants will perform an incremental treadmill test to volitional exhaustion. Indirect calorimetry will be used to assess oxygen consumption and carbon dioxide production to determine the participant's aerobic capacity.

Testing sessions: Participants will perform two testing sessions separated by at least 5 days. One session will take place during the last week of active pill consumption of monophasic hormonal contraceptives. The second session will take place during the placebo pill consumption phase (i.e. menses). Participants will be asked to arrive at the lab at around 4:00 pm for both sessions, which will be randomly assigned. During the sessions, participants will be asked to perform 45 minutes of aerobic exercise on an ergonomic cycle ergometer at 60% of the participant's pre-determined aerobic capacity. Blood samples will be drawn at baseline, at the end of exercise, and an hour post-exercise via an IV catheter. Participants will be asked to match their daily food and insulin intake as closely as possible from one testing session to the next for the day before, day of and day after the testing session. They will also be asked to avoid strenuous exercise and alcohol intake.

A continuous glucose monitor (CGM) sensor will be subcutaneously inserted by one of the investigators (trained by a group from the CGM manufacturer) into the anterior abdominal area of the participant in the morning of the day prior to each testing session. The participant will wear the CGM for at least 24 hours before the exercise session, and at least 24 hours after the exercise session.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 1 diabetes diagnosed for at least 1 year
  • regular menses
  • using monophasic oral contraceptives
  • residing in Edmonton, Alberta and able to visit the lab at the University of Alberta

Exclusion criteria

  • HbA1c > 9.9%
  • frequent and unpredictable hypoglycemia
  • change in insulin management strategy within two months of the study
  • use of an automated insulin delivery system
  • blood pressure > 140/95
  • history of cardiovascular disease
  • severe peripheral neuropathy
  • active proliferative retinopathy
  • use of medications (other than insulin) that would affect blood glucose levels
  • any musculoskeletal condition that would contraindicate exercise (e.g. sprain, strain, joint injury, etc.)

Treatment and study plan

Luteal Phase Aerobic Exercise

Behavioral

Participants will perform 45 minutes of moderate (60% VO2peak) aerobic exercise on a cycle ergometer during the last week of active pill consumption.

Follicular Phase Aerobic Exercise

Behavioral

Participants will perform 45 minutes of moderate (60% VO2peak) aerobic exercise on a cycle ergometer within 5 days of starting their menses.

Primary outcomes

  1. Blood glucose

    Time frame: Pre-exercise (0 minutes), post-exercise (45 minutes) and 1 hour post-exercise

    Change in blood glucose, with samples drawn via IV catheter

Secondary outcomes

  1. Interstitial glucose (continuous glucose monitoring)

    Time frame: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise

    Mean CGM glucose

  2. coefficient of variation (CV)

    Time frame: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise

    measure of variability for continuous glucose monitoring data

  3. standard deviation (SD)

    Time frame: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise

    measure of variability for continuous glucose monitoring data

  4. frequency of hypoglycemia

    Time frame: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise

    number of times that CGM glucose is equal to or lower than 3.9 mmol/L

  5. frequency of hyperglycemia

    Time frame: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise

    number of times that CMG glucose is equal to or greater than 10.0 mmol/L

  6. percent of time in range

    Time frame: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise

    percent of time with CGM glucose between 4.0 and 9.9 mmol/L

  7. percent of time in hypoglycemia

    Time frame: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise

    amount of time spent with CGM glucose equal to or less than 3.9 mmol/L

  8. percent of time in hyperglycemia

    Time frame: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise

    amount of time spent with CGM glucose equal to or greater than 10.0 mmol/L

Other outcomes

  1. Carbohydrate supplementation

    Time frame: Between 0 minutes and 45 minutes (during exercise)

    Grams of carbohydrate provided to prevent hypoglycemia

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Women and Children's Health Research Institute, Canada

Registry information

Official study title

Effects of the Menstrual Cycle on Blood Glucose Changes During Exercise in Women With Type 1 Diabetes Using Oral Contraceptives

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2022
Registry last updated
Jul 20, 2026

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.

Published trials that share one or more normalized conditions with this study.