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Repeatability of Blood Glucose Responses to Resistance Exercise in Type 1 Diabetes

Repeatability of Blood Glucose Responses to Fasted and Fed Resistance Exercise in Individuals With Type 1 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05168488
Enrollment
27
Registered
2021-12-23
Start date
2021-11-16
Completion date
2023-12-16
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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.

Interventions

BEHAVIORALFasted morning resistance exercise

On three separate occasions, participants will perform a standardized resistance exercise protocol in the morning while fasting.

BEHAVIORALAfternoon resistance exercise

On three separate occasions participants will perform a standardized resistance exercise protocol in the afternoon after eating their regular lunch

Sponsors

DexCom, Inc.
CollaboratorINDUSTRY
University of Alberta
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Capillary glucose (change during exercise)0 minutes (exercise start), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutesUsing test strips and a hand-held glucometer to test blood from a finger poke

Secondary

MeasureTime frameDescription
CGM coefficient of variation (CV)6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercisecoefficient of variation of continuous glucose monitoring data
CGM standard deviation (SD)6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exerciseStandard deviation of CGM glucose
frequency of hypoglycemia6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercisenumber of hypoglycemic events measured by CGM
Mean CGM glucose6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercisemean CGM glucose
percent time in range6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercisepercent of time spent between 4.0 and 9.9 mmol/L
percent time in hyperglycemia6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercisepercent of time spent over 10.0 mmol/L
percent time in hypoglycemia6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercisepercent of time spent below 3.9 mmol/L
frequency of hyperglycemia6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercisenumber of hyperglycemic events measured by CGM

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 16, 2026