Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes, Post-menopause
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aerobic Exercise
Resistance Exercise
No exercise
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes focused on measuring Exercise, Physical activity
Eligibility Criteria
Inclusion Criteria:
- type 1 diabetes, diagnosed for at least one year
- post-menopause (at least one year since last menstrual period), or have had a hysterectomy and bilateral salpingo oophorectomy
- able to perform aerobic and resistance exercise
- able to visit the lab in Edmonton, Alberta (University of Alberta)
Exclusion Criteria:
- HbA1c > 9.9 %
- frequent and unpredictable hypoglycemia
- change in insulin management strategy within the last 2 months
- blood pressure > 140 / 95
- severe peripheral neuropathy
- history of cardiovascular disease
- musculoskeletal injuries interfering with exercise performance
- use of medications (other than insulin) that affect glucose metabolism
- BMI > 30 kg/m2
- smoking
- moderate to high alcohol intake (> 2 drinks/day)
Sites / Locations
- Alberta Diabetes InstituteRecruiting
- Institut de recherches cliniques de MontréalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
All participants will take part in all three testing conditions
Outcomes
Primary Outcome Measures
Blood glucose
Change in blood glucose
Secondary Outcome Measures
mean continuous glucose monitoring (CGM) glucose
mean of all measurements over the selected time frames
coefficient of variation (CV) of CGM glucose
CV of CGM glucose over the selected time frames
standard deviation (SD)
SD of CGM glucose over the selected time frames
frequency of hypoglycemia
number of times that CGM glucose is equal to or less than 3.9 mmol/L
frequency of hyperglycemia
number of times that CGM glucose is equal to or greater than 10.0 mmol/L
percent time spent in hyperglycemia
percentage of time spent with CGM glucose equal to or greater than 10.0 mmol/L
percent time spent in hypoglycemia
percentage of time spent with CGM glucose equal to or lower than 3.9 mmol/L
percent time spent in range
percent of time spent with CGM glucose between 4.0 and 9.9 mmol/L
carbohydrate supplementation
grams of carbohydrate provided during exercise to prevent hypoglycemia
Full Information
NCT ID
NCT05188027
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
NCT05188027
Brief Title
Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
Official Title
Acute Glycemic Effects of Aerobic and Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (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
Participants will be asked to wear a continuous glucose monitor for at least three days on three separate occasions. One testing session will be a no-exercise resting control session (90 minutes). One will be a moderate aerobic exercise session (30 minutes of exercise, 60 minutes of recovery), and the third will be a moderate weight-lifting session (~30 minutes of exercise, 60 minutes of recovery).The investigators will measure changes in blood glucose during exercise by drawing blood during and after exercise. Post-exercise glucose trends will be examined using continuous glucose monitoring.
Detailed Description
Pre-test measures: Interested participants will be invited to either the Exercise Physiology laboratory the Augustana campus of the University of Alberta, or the Physical Activity and Diabetes Laboratory on the main campus of the University of Alberta. They will be asked questions related to menopause, PA levels, and medication. Blood pressure and heart rate will also be measured. Where participants are eligible, anthropometric characteristics will be measured using standard protocols. A blood sample will be drawn for assessment of HbA1c. Those who meet all eligibility criteria and complete informed consent forms will be asked to complete the initial exercise tests. Participants will perform a maximal aerobic capacity test with ECG monitoring, under the supervision of a certified exercise physiologist. Indirect calorimetry will be used to assess oxygen consumption and carbon dioxide production and will be used to extrapolate the participant's aerobic capacity. Participants will undergo a strength test for each of the ten exercises involved in the study, in order to estimate the their 1 repetition maximum. Participants will also be asked to undergo a dual energy x-ray absorptiometry (DXA) scan for body composition in the Clinical Research Unit at the Alberta Diabetes Institute. While this procedure generally requires proof of a negative pregnancy test, participants will be provided with a waiver in order to decline this test (in light of their menopausal status).
Testing sessions: Participants will be asked to arrive at the lab at around 4:00 pm for all three sessions, which will be randomly assigned. During the sessions, participants will be asked to perform one of the three activities: 1) seated rest 2) aerobic exercise (walking on a treadmill at 50% of the participant's pre-determined VO2max) or 3) resistance exercise consisting of 1 set of 10 repetitions of 10 different exercises with 90 seconds rest between sets. Blood samples will be drawn at baseline, after 10, 20 and 30 minutes of exercise, along with 30- and 60-minutes post-exercise via an IV catheter. Indirect calorimetry will be used to ensure that the participant is exercising at the appropriate intensity. 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. The investigators will provide them with log sheets to assist in this task. They will also be asked to avoid strenuous exercise and alcohol intake.
A 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, or on the back of the arm of the participant, approximately 2 days prior to the first testing session. The Dexcom G6 CGM receiver will store glucose data every 5 minutes for up to 10 days. The participant will be instructed on how to remove their sensor at least 24 hours after the exercise session, and will be asked to return the receiver to enable the upload of their data to Dexcom Clarity by the study team.
Interviews: During the third and final testing session, study participants will be invited to answer questions about their study participation experience, exercise preferences, barriers to exercise, and other information they feel may improve their exercise experience. These interviews will be audio recorded and transcribed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Post-menopause
Keywords
Exercise, Physical activity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Experimental
Arm Description
All participants will take part in all three testing conditions
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
Walking at 60% of maximal aerobic capacity on a treadmill
Intervention Type
Other
Intervention Name(s)
Resistance Exercise
Intervention Description
Performing one set of 10 repetitions of 10 different weight-lifting exercises
Intervention Type
Other
Intervention Name(s)
No exercise
Intervention Description
Participants will rest in a supine position for 30 minutes.
Primary Outcome Measure Information:
Title
Blood glucose
Description
Change in blood glucose
Time Frame
From 0 minutes to 45 minutes (beginning to the end of exercise/control) and then for 60 minutes after exercise
Secondary Outcome Measure Information:
Title
mean continuous glucose monitoring (CGM) glucose
Description
mean of all measurements over the selected time frames
Time Frame
6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
Title
coefficient of variation (CV) of CGM glucose
Description
CV of CGM glucose over the selected time frames
Time Frame
6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
Title
standard deviation (SD)
Description
SD of CGM glucose over the selected time frames
Time Frame
6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
Title
frequency of hypoglycemia
Description
number of times that CGM glucose is equal to or less than 3.9 mmol/L
Time Frame
6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
Title
frequency of hyperglycemia
Description
number of times that CGM glucose is equal to or greater than 10.0 mmol/L
Time Frame
6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
Title
percent time spent in hyperglycemia
Description
percentage of time spent with CGM glucose equal to or greater than 10.0 mmol/L
Time Frame
6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
Title
percent time spent in hypoglycemia
Description
percentage of time spent with CGM glucose equal to or lower than 3.9 mmol/L
Time Frame
6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
Title
percent time spent in range
Description
percent of time spent with CGM glucose between 4.0 and 9.9 mmol/L
Time Frame
6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise
Title
carbohydrate supplementation
Description
grams of carbohydrate provided during exercise to prevent hypoglycemia
Time Frame
from 0 minutes to 45 minutes (during exercise)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 1 diabetes, diagnosed for at least one year
post-menopause (at least one year since last menstrual period), or have had a hysterectomy and bilateral salpingo oophorectomy
able to perform aerobic and resistance exercise
able to visit the lab in Edmonton, Alberta (University of Alberta)
Exclusion Criteria:
HbA1c > 9.9 %
frequent and unpredictable hypoglycemia
change in insulin management strategy within the last 2 months
blood pressure > 140 / 95
severe peripheral neuropathy
history of cardiovascular disease
musculoskeletal injuries interfering with exercise performance
use of medications (other than insulin) that affect glucose metabolism
BMI > 30 kg/m2
smoking
moderate to high alcohol intake (> 2 drinks/day)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jane E Yardley, PhD
Phone
780-679-1688
Email
jane.yardley@ualberta.ca
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
Facility Name
Institut de recherches cliniques de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Yardley, PhD
Email
jane.yardley@ircm.qc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
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