Type 1 DiabetesNCT05168488
Repeatability of Blood Glucose Responses to Resistance Exercise in Type 1 Diabetes
A study testing Fasted morning resistance exercise and Afternoon resistance exercise in people with Type 1 Diabetes, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Fasted morning resistance exercise and Afternoon resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 16 Nov 2021to 16 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- type 1 diabetes diagnosed for at least 1 year
- aged 18 to 55 years
Who cannot join
- 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
Show all 9Show fewer
- severe peripheral neuropathy
- a history of cardiovascular disease
- severe proliferative retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repeatability of Blood Glucose Responses to Fasted and Fed Resistance Exercise in Individuals With Type 1 Diabetes
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Fasted morning resistance exercise, Afternoon resistance exercise
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasted morning resistance exerciseBehavioural
On three separate occasions, participants will perform a standardized resistance exercise protocol in the morning while fasting.
Afternoon resistance exerciseBehavioural
On three separate occasions participants will perform a standardized resistance exercise protocol in the afternoon after eating their regular lunch
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | There is only one study arm consisting of all participants. Receives: Behavioral: Fasted morning resistance exercise; Behavioral: Afternoon resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary glucose (change during exercise)
Using test strips and a hand-held glucometer to test blood from a finger poke
Measured: 0 minutes (exercise start), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes
Secondary outcomes (8)
Mean CGM glucose
mean CGM glucose
Measured: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
CGM coefficient of variation (CV)
coefficient of variation of continuous glucose monitoring data
Measured: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
CGM standard deviation (SD)
Standard deviation of CGM glucose
Measured: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
frequency of hypoglycemia
number of hypoglycemic events measured by CGM
Measured: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
frequency of hyperglycemia
number of hyperglycemic events measured by CGM
Measured: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
percent time in range
percent of time spent between 4.0 and 9.9 mmol/L
Measured: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
percent time in hyperglycemia
percent of time spent over 10.0 mmol/L
Measured: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
percent time in hypoglycemia
percent of time spent below 3.9 mmol/L
Measured: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start16 Nov 2021
- Primary completion16 Dec 2023
- Study completion16 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168488
- Sponsor's protocol ID
- Pro00082031
- Status last verified
- Jan 2024
- First submitted
- 22 Nov 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McClure RD, Carr ALJ, Boule NG, Yardley JE. The glycaemic response to morning fasted resistance exercise is more consistent than the response to afternoon fed resistance exercise for adults with type 1 diabetes: a randomised crossover comparison. Diabetologia. 2026 Jul;69(7):1782-1791. doi: 10.1007/s00125-026-06713-6. Epub 2026 Mar 14.
PubMed 41831023
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability of Blood Glucose Responses to Fasted and Fed Resistance Exercise in Individuals With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05168488
- Acronym / sponsor ID
- Pro00082031
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 16 Dec 2023 (actual)
- Study completion
- 16 Dec 2023 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Behavioral: Fasted morning resistance exercise, Behavioral: Afternoon resistance exerciseThere is only one study arm consisting of all participants. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- type 1 diabetes diagnosed for at least 1 year
- aged 18 to 55 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasted morning resistance exerciseOn three separate occasions, participants will perform a standardized resistance exercise protocol in the morning while fasting. | Behavioural | All participants |
| Afternoon resistance exerciseOn three separate occasions participants will perform a standardized resistance exercise protocol in the afternoon after eating their regular lunch | Behavioural | All participants |
Primary outcome
Capillary glucose (change during exercise)
Time frame: 0 minutes (exercise start), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes
Using test strips and a hand-held glucometer to test blood from a finger poke
8 secondary outcomes
Mean CGM glucose
Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
CGM coefficient of variation (CV)
Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
CGM standard deviation (SD)
Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
frequency of hypoglycemia
Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
frequency of hyperglycemia
Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
percent time in range
Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
percent time in hyperglycemia
Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
percent time in hypoglycemia
Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 41831023McClure RD, Carr ALJ, Boule NG, Yardley JE. The glycaemic response to morning fasted resistance exercise is more consistent than the response to afternoon fed resistance exercise for adults with type 1 diabetes: a randomised crossover comparison. Diabetologia. 2026 Jul;69(7):1782-1791. doi: 10.1007/s00125-026-06713-6. Epub 2026 Mar 14.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasted morning resistance exercise and Afternoon resistance exercise in people with Type 1 Diabetes, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary glucose (change during exercise) (time frame: 0 minutes (exercise start), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05168488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.