Exercise and the Menstrual Cycle in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Luteal Phase Aerobic Exercise
Follicular Phase Aerobic Exercise
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes
Eligibility Criteria
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.)
Sites / Locations
- Alberta Diabetes InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
All participants will be in a single study arm.
Outcomes
Primary Outcome Measures
Blood glucose
Change in blood glucose, with samples drawn via IV catheter
Secondary Outcome Measures
Interstitial glucose (continuous glucose monitoring)
Mean CGM glucose
coefficient of variation (CV)
measure of variability for continuous glucose monitoring data
standard deviation (SD)
measure of variability for continuous glucose monitoring data
frequency of hypoglycemia
number of times that CGM glucose is equal to or lower than 3.9 mmol/L
frequency of hyperglycemia
number of times that CMG glucose is equal to or greater than 10.0 mmol/L
percent of time in range
percent of time with CGM glucose between 4.0 and 9.9 mmol/L
percent of time in hypoglycemia
amount of time spent with CGM glucose equal to or less than 3.9 mmol/L
percent of time in hyperglycemia
amount of time spent with CGM glucose equal to or greater than 10.0 mmol/L
Full Information
NCT ID
NCT05188014
First Posted
December 8, 2021
Last Updated
October 3, 2023
Sponsor
University of Alberta
Collaborators
Women and Children's Health Research Institute, Canada
1. Study Identification
Unique Protocol Identification Number
NCT05188014
Brief Title
Exercise and the Menstrual Cycle in Type 1 Diabetes
Official Title
Effects of the Menstrual Cycle on Blood Glucose Changes During Exercise in Women With Type 1 Diabetes Using Oral Contraceptives
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Women and Children's Health Research Institute, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Experimental
Arm Description
All participants will be in a single study arm.
Intervention Type
Behavioral
Intervention Name(s)
Luteal Phase Aerobic Exercise
Intervention Description
Participants will perform 45 minutes of moderate (60% VO2peak) aerobic exercise on a cycle ergometer during the last week of active pill consumption.
Intervention Type
Behavioral
Intervention Name(s)
Follicular Phase Aerobic Exercise
Intervention Description
Participants will perform 45 minutes of moderate (60% VO2peak) aerobic exercise on a cycle ergometer within 5 days of starting their menses.
Primary Outcome Measure Information:
Title
Blood glucose
Description
Change in blood glucose, with samples drawn via IV catheter
Time Frame
Pre-exercise (0 minutes), post-exercise (45 minutes) and 1 hour post-exercise
Secondary Outcome Measure Information:
Title
Interstitial glucose (continuous glucose monitoring)
Description
Mean CGM glucose
Time Frame
6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Title
coefficient of variation (CV)
Description
measure of variability for continuous glucose monitoring data
Time Frame
6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Title
standard deviation (SD)
Description
measure of variability for continuous glucose monitoring data
Time Frame
6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Title
frequency of hypoglycemia
Description
number of times that CGM glucose is equal to or lower than 3.9 mmol/L
Time Frame
6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Title
frequency of hyperglycemia
Description
number of times that CMG glucose is equal to or greater than 10.0 mmol/L
Time Frame
6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Title
percent of time in range
Description
percent of time with CGM glucose between 4.0 and 9.9 mmol/L
Time Frame
6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Title
percent of time in hypoglycemia
Description
amount of time spent with CGM glucose equal to or less than 3.9 mmol/L
Time Frame
6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Title
percent of time in hyperglycemia
Description
amount of time spent with CGM glucose equal to or greater than 10.0 mmol/L
Time Frame
6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Other Pre-specified Outcome Measures:
Title
Carbohydrate supplementation
Description
Grams of carbohydrate provided to prevent hypoglycemia
Time Frame
Between 0 minutes and 45 minutes (during exercise)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
Alberta Diabetes Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane E Yardley, PhD
Phone
7806791688
Email
jane.yardley@ualberta.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise and the Menstrual Cycle in Type 1 Diabetes
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