Exercise and the Menstrual Cycle in Type 1 Diabetes

NCT05188014 | Recruiting

• 1 other identifier: Pro0083867
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Blood glucose

  Change in blood glucose, with samples drawn via IV catheter

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

Secondary Outcomes (8)

• Interstitial glucose (continuous glucose monitoring)

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

• coefficient of variation (CV)

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

• standard deviation (SD)

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

• frequency of hypoglycemia

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

• frequency of hyperglycemia

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

Other Outcomes (1)

• Carbohydrate supplementation

  Between 0 minutes and 45 minutes (during exercise)

Study Arms (1)

All participants

EXPERIMENTAL

All participants will be in a single study arm.

Behavioral: Luteal Phase Aerobic Exercise; Behavioral: Follicular Phase Aerobic Exercise

Interventions

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.

All participants

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.

All participants

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Alberta: lead
• Women and Children's Health Research Institute, Canada: collaborator

Study Sites (1)

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 12, 2022
• Study Start: March 15, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)