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Type 1 DiabetesNCT05188014

Exercise and the Menstrual Cycle in Type 1 Diabetes

A study testing Luteal Phase Aerobic Exercise and Follicular Phase Aerobic Exercise in people with Type 1 Diabetes, run by University of Alberta at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Type 1 Diabetes
What is being tested?
Luteal Phase Aerobic Exercise and Follicular Phase Aerobic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
15 Mar 2022to 30 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting

  • Alberta Diabetes Institute

    Edmonton, Alberta, T6G 2R3

    Jane E Yardley, PhD, 7806791688, jane.yardley@ualberta.ca

    Recruiting

Other trials in Canada

About this study

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

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.

Read the detailed description

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.

Conditions
Type 1 Diabetes
Being tested
Luteal Phase Aerobic Exercise, Follicular Phase Aerobic Exercise
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Luteal Phase Aerobic ExerciseBehavioural

    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 ExerciseBehavioural

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

Study groups in NCT05188014
Study groupRoleWhat they receive
All participantsExperimentalAll participants will be in a single study arm.
Receives: Behavioral: Luteal Phase Aerobic Exercise; Behavioral: Follicular Phase Aerobic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood glucose

    Change in blood glucose, with samples drawn via IV catheter

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

Secondary outcomes (8)

  1. Interstitial glucose (continuous glucose monitoring)

    Mean CGM glucose

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

  2. coefficient of variation (CV)

    measure of variability for continuous glucose monitoring data

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

  3. standard deviation (SD)

    measure of variability for continuous glucose monitoring data

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

  4. frequency of hypoglycemia

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

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

  5. frequency of hyperglycemia

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

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

  6. percent of time in range

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

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

  7. percent of time in hypoglycemia

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

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

  8. percent of time in hyperglycemia

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2022
  2. Study start15 Mar 2022
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05188014
Sponsor's protocol ID
Pro0083867
Status last verified
Jul 2026
First submitted
8 Dec 2021
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Luteal Phase Aerobic Exercise and Follicular Phase Aerobic Exercise in people with Type 1 Diabetes, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood glucose (time frame: Pre-exercise (0 minutes), post-exercise (45 minutes) and 1 hour post-exercise). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05188014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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