Repeatability of Blood Glucose Responses to Resistance Exercise in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fasted morning resistance exercise
Afternoon resistance 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
- aged 18 to 55 years
Exclusion Criteria:
- HbA1c > 9.9%
- frequent and unpredictable hypoglycemia
- change in insulin management strategy within two months of study
- using closed-loop insulin delivery
- injuries that would contraindicate resistance exercise
- blood pressure > 140/95
- severe peripheral neuropathy
- a history of cardiovascular disease
- severe proliferative retinopathy
Sites / Locations
- Alberta Diabetes InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
There is only one study arm consisting of all participants.
Outcomes
Primary Outcome Measures
Capillary glucose (change during exercise)
Using test strips and a hand-held glucometer to test blood from a finger poke
Secondary Outcome Measures
Mean CGM glucose
mean CGM glucose
CGM coefficient of variation (CV)
coefficient of variation of continuous glucose monitoring data
CGM standard deviation (SD)
Standard deviation of CGM glucose
frequency of hypoglycemia
number of hypoglycemic events measured by CGM
frequency of hyperglycemia
number of hyperglycemic events measured by CGM
percent time in range
percent of time spent between 4.0 and 9.9 mmol/L
percent time in hyperglycemia
percent of time spent over 10.0 mmol/L
percent time in hypoglycemia
percent of time spent below 3.9 mmol/L
Full Information
NCT ID
NCT05168488
First Posted
November 22, 2021
Last Updated
January 10, 2023
Sponsor
University of Alberta
Collaborators
DexCom, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05168488
Brief Title
Repeatability of Blood Glucose Responses to Resistance Exercise in Type 1 Diabetes
Official Title
Repeatability of Blood Glucose Responses to Fasted and Fed Resistance Exercise in Individuals 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 16, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
DexCom, Inc.
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
This study proposes to examine the impact of time of day (morning versus afternoon) on the variability of blood glucose responses to high resistance exercise in a single group of patients with type 1 diabetes. Participants will be asked to wear a continuous glucose monitor during the 3 weeks of testing. During the six exercise sessions (three in the morning while fasted and three in the afternoon), participants will complete the same resistance exercise protocol.
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 physical activity levels and medication, and blood pressure will be measured to assess their eligibility. Where participants are eligible, anthropometric characteristics will be measured using standard protocols, as will blood pressure. A blood sample will be drawn for assessment of HbA1c. Participants will be introduced to the weight lifting equipment and the proper lifting techniques associated with each exercise prior to performing a standardized test to determine the maximum weight they can safely lift eight times while maintaining proper form (8 repetition maximum - 8RM).
Testing sessions: Participants will be asked to arrive at the lab either between 7 and 8 am in a fasting state, or between 4 pm and 5 pm. The three morning and three afternoon testing sessions will have identical exercise protocols. Participants will be asked to perform three sets of eight repetitions of seven different exercises (bench press leg press, shoulder press, leg curl, lat pulldown, abdominal crunches, seated row) at their pre-determined 8RM. Participants will be asked to match their food and insulin intake as closely as possible on testing days to avoid having these as confounders.
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 the first testing session. CGM will store glucose data every 5 minutes for up to 7 days. During this time, participants will be asked to wear an accelerometer to allow for the objective assessment of background physical activity and sleep quality. Along with this device, they will fill out an activity and sleep log to improve the analysis of the data.
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
There is only one study arm consisting of all participants.
Intervention Type
Behavioral
Intervention Name(s)
Fasted morning resistance exercise
Intervention Description
On three separate occasions, participants will perform a standardized resistance exercise protocol in the morning while fasting.
Intervention Type
Behavioral
Intervention Name(s)
Afternoon resistance exercise
Intervention Description
On three separate occasions participants will perform a standardized resistance exercise protocol in the afternoon after eating their regular lunch
Primary Outcome Measure Information:
Title
Capillary glucose (change during exercise)
Description
Using test strips and a hand-held glucometer to test blood from a finger poke
Time Frame
0 minutes (exercise start), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes
Secondary Outcome Measure Information:
Title
Mean CGM glucose
Description
mean CGM glucose
Time Frame
6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
Title
CGM coefficient of variation (CV)
Description
coefficient of variation of continuous glucose monitoring data
Time Frame
6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
Title
CGM standard deviation (SD)
Description
Standard deviation of CGM glucose
Time Frame
6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
Title
frequency of hypoglycemia
Description
number of hypoglycemic events measured by CGM
Time Frame
6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
Title
frequency of hyperglycemia
Description
number of hyperglycemic events measured by CGM
Time Frame
6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
Title
percent time in range
Description
percent of time spent between 4.0 and 9.9 mmol/L
Time Frame
6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
Title
percent time in hyperglycemia
Description
percent of time spent over 10.0 mmol/L
Time Frame
6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
Title
percent time in hypoglycemia
Description
percent of time spent below 3.9 mmol/L
Time Frame
6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 1 diabetes diagnosed for at least 1 year
aged 18 to 55 years
Exclusion Criteria:
HbA1c > 9.9%
frequent and unpredictable hypoglycemia
change in insulin management strategy within two months of study
using closed-loop insulin delivery
injuries that would contraindicate resistance exercise
blood pressure > 140/95
severe peripheral neuropathy
a history of cardiovascular disease
severe proliferative retinopathy
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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Repeatability of Blood Glucose Responses to Resistance Exercise in Type 1 Diabetes
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