Diabetes Mellitus, Type 1HOME T1DNCT05740514
Healthy Outcomes for Muscle with Exercise in T1D
A study testing Exercise and De-training in people with Diabetes Mellitus, Type 1, run by McMaster University at 1 site in Canada.
Trial summary
Over 300,000 people in Canada suffer from Type 1 Diabetes (T1D), a chronic condition whose incidence rate has been increasing in Canada every year by 5.1% (higher than the global average). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Exercise and De-training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2023to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18-30 or 45-65
- Sedentary or recreationally active, as defined by self-reported activity levels below the recommended 150-minute minimum of moderate-to-vigorous intensity physical activity per week
Who cannot join
- Chronic use of anti-inflammatory, glucocorticoid, or other pain-relief medication
- History of daily cannabis, tobacco, or nicotine use within six months of study initiation
- BMI >30kg/m2
- Prediabetes
- Type 2 diabetes
- Health conditions that put the subject at risk to participate in exercise during this study
- Atypical or Grade 2b diabetic sensorimotor polyneuropathy
- More than one lifetime event of hospitalization for diabetic ketoacidosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4L8
Rebecca Leone, 905-525-9140, rleone@mcmaster.ca
Thomas J Hawke, PhD
About this study
Official title: Targeting Vascular and Skeletal Muscle Health to Improve Quality of Life in Males and Females with Type 1 Diabetes
Over 300,000 people in Canada suffer from Type 1 Diabetes (T1D), a chronic condition whose incidence rate has been increasing in Canada every year by 5.1% (higher than the global average). While exogenous insulin injections allow those with T1D to live, it is not a cure, and those with T1D develop severe complications (kidney failure, cardiovascular disease). Strategies to regress the development of these complications, minimize healthcare system burden, and save the lives of Canadians are urgently needed.
Undertaking regular exercise is an obvious strategy for those with T1D and has many well-established health benefits. Despite these benefits, adults with T1D exercise less frequently due to fear of severe hypoglycemia and a lack of knowledge of effective exercise strategies. Adding to this complexity, the investigators have recently shown that males and females elicit differential impairments in skeletal muscle metabolism in response to T1D. These differences may extend to the peripheral microvasculature and may lead to sexual dimorphism in the health benefits of exercise for those with T1D. Ultimately, developing a healthy muscle mass, including microvasculature, will help mitigate dysglycemic and dyslipidemic fluctuations and improve insulin sensitivity.
The overarching purpose of this proposed study is to determine the impact of T1D on human skeletal muscle and its microvasculature over the lifespan in males and females, and its responses to exercise training and detraining.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Exercise, De-training
- 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.
ExerciseBehavioural
Exercise training.
De-trainingBehavioural
Exercise de-training via unilateral knee immobilization.
| Study group | Role | What they receive |
|---|---|---|
| Twelve-week Exercise | Experimental | Study participants will participate in an exercise program consisting of aerobic and resistance exercise. This arm will last twelve weeks. Receives: Behavioral: Exercise |
| One-week Detraining | Experimental | Study participants will undergo unilateral knee immobilization for a one-week period. Receives: Behavioral: De-training |
| Four-week Re-training | Experimental | Study participants will once again participate in an exercise program consisting of aerobic and resistance exercise. This arm will last four weeks. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description)
Individuals with T1D as well as their age, sex, and BMI-matched control counterparts will undergo various physiological assessments to evaluate their muscle health: strength/aerobic fitness testing, compartmental body composition assessment, blood analysis, glucose monitoring, muscle biopsy, motor neuron function evaluation, and assessments of muscle microvascular structure and function. All metrics will be compared between individuals with T1D and their non-T1D counterparts.
Measured: At time of study start (baseline characteristics)
Secondary outcomes (3)
The effect of twelve weeks of exercise on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)
Following baseline assessments, study participants will undergo a combined aerobic and resistance training program for twelve weeks. Following twelve weeks of participation in this exercise program, all study participants will undergo various physiological assessments to evaluate their muscle health: strength/aerobic fitness testing, compartmental body composition assessment, blood analysis, glucose monitoring, muscle biopsy, motor neuron function evaluation, and assessments of muscle microvascular structure and function.
Measured: Twelve weeks following study initiation
The acute effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)
Following completion of the aforementioned twelve week exercise program, study participants will undergo a seven-day detraining period consisting of unilateral knee immobilization using a hinged knee-joint immobilization brace. Immediately following this immobilization period, all study participants will undergo various physiological assessments to evaluate their muscle health: strength/aerobic fitness testing, compartmental body composition assessment, blood analysis, glucose monitoring, muscle biopsy, motor neuron function evaluation, and assessments of muscle microvascular structure and function.
Measured: Thirteen weeks following study initiation
The effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)
Following completion of the aforementioned twelve week exercise program, study participants will undergo a seven-day detraining period consisting of unilateral knee immobilization using a hinged knee-joint immobilization brace. Four weeks after this immobilization period, all study participants will undergo various physiological assessments to evaluate their muscle health: strength/aerobic fitness testing, compartmental body composition assessment, blood analysis, glucose monitoring, muscle biopsy, motor neuron function evaluation, and assessments of muscle microvascular structure and function.
Measured: Seventeen weeks following study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Oct 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
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 Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Study subjects will participate in a twelve-week exercise program. Following this time, a one-week detraining period will ensue. Following this detraining period, study subjects will re-engage in a four-week exercise program.
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Hawke, McMaster University
- Investigators
- Thomas J Hawke, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740514
- Sponsor's protocol ID
- 15516
- Acronym
- HOME T1D
- Status last verified
- Dec 2024
- First submitted
- 25 Jan 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data - after deidentification.
Publications
Rebalka IA, Noguchi KS, Bulyovsky KR, Badour MI, Juracic ES, Barrett K, Brahmbhatt A, Al-Khazraji B, Punthakee Z, Perry CGR, Kumbhare DA, MacDonald MJ, Hawke TJ. Targeting skeletal muscle health with exercise in people with type 1 diabetes: A protocol for HOMET1D, a prospective observational trial with matched controls. PLoS One. 2024 May 22;19(5):e0303448. doi: 10.1371/journal.pone.0303448. eCollection 2024.
PubMed 38776307
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Vascular and Skeletal Muscle Health to Improve Quality of Life in Males and Females with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05740514
- Acronym / sponsor ID
- HOME T1D / 15516
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Feb 2023 (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.
Over 300,000 people in Canada suffer from Type 1 Diabetes (T1D), a chronic condition whose incidence rate has been increasing in Canada every year by 5.1% (higher than the global average). While exogenous insulin injections allow those with T1D to live, it is not a cure, and those with T1D develop severe complications (kidney failure, cardiovascular disease). Strategies to regress the development of these complications, minimize healthcare system burden, and save the lives of Canadians are urgently needed.
Undertaking regular exercise is an obvious strategy for those with T1D and has many well-established health benefits. Despite these benefits, adults with T1D exercise less frequently due to fear of severe hypoglycemia and a lack of knowledge of effective exercise strategies. Adding to this complexity, the investigators have recently shown that males and females elicit differential impairments in skeletal muscle metabolism in response to T1D. These differences may extend to the peripheral microvasculature and may lead to sexual dimorphism in the health benefits of exercise for those with T1D. Ultimately, developing a healthy muscle mass, including microvasculature, will help mitigate dysglycemic and dyslipidemic fluctuations and improve insulin sensitivity.
The overarching purpose of this proposed study is to determine the impact of T1D on human skeletal muscle and its microvasculature over the lifespan in males and females, and its responses to exercise training and detraining.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Study subjects will participate in a twelve-week exercise program. Following this time, a one-week detraining period will ensue. Following this detraining period, study subjects will re-engage in a four-week exercise program.
| Arm | Type | Receives |
|---|---|---|
| Twelve-week Exercise | Experimental | Behavioral: ExerciseStudy participants will participate in an exercise program consisting of aerobic and resistance exercise. This arm will last twelve weeks. |
| One-week Detraining | Experimental | Behavioral: De-trainingStudy participants will undergo unilateral knee immobilization for a one-week period. |
| Four-week Re-training | Experimental | Behavioral: ExerciseStudy participants will once again participate in an exercise program consisting of aerobic and resistance exercise. This arm will last four weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 18-30 or 45-65
- Sedentary or recreationally active, as defined by self-reported activity levels below the recommended 150-minute minimum of moderate-to-vigorous intensity physical activity per week
Key exclusion criteria (8 listed)
- Chronic use of anti-inflammatory, glucocorticoid, or other pain-relief medication
- History of daily cannabis, tobacco, or nicotine use within six months of study initiation
- BMI >30kg/m2
- Prediabetes
- Type 2 diabetes
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 |
|---|---|---|
| ExerciseExercise training. | Behavioural | Four-week Re-training, Twelve-week Exercise |
| De-trainingExercise de-training via unilateral knee immobilization. | Behavioural | One-week Detraining |
Primary outcome
The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description)
Time frame: At time of study start (baseline characteristics)
Individuals with T1D as well as their age, sex, and BMI-matched control counterparts will undergo various physiological assessments to evaluate their muscle health: strength/aerobic fitness testing, compartmental body composition assessment, blood analysis, glucose monitoring, muscle biopsy, motor neuron function evaluation, and assessments of muscle microvascular structure and function. All metrics will be compared between individuals with T1D and their non-T1D counterparts.
3 secondary outcomes
The effect of twelve weeks of exercise on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)
Time frame: Twelve weeks following study initiation
The acute effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)
Time frame: Thirteen weeks following study initiation
The effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)
Time frame: Seventeen weeks following study initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 38776307Rebalka IA, Noguchi KS, Bulyovsky KR, Badour MI, Juracic ES, Barrett K, Brahmbhatt A, Al-Khazraji B, Punthakee Z, Perry CGR, Kumbhare DA, MacDonald MJ, Hawke TJ. Targeting skeletal muscle health with exercise in people with type 1 diabetes: A protocol for HOMET1D, a prospective observational trial with matched controls. PLoS One. 2024 May 22;19(5):e0303448. doi: 10.1371/journal.pone.0303448. eCollection 2024.
- Individual participant dataSharing planned: Yes. Participant data - after deidentification.
Related trials for Diabetes Mellitus, Type 1
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.
Thomas J Hawke, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and De-training in people with Diabetes Mellitus, Type 1, run by McMaster University 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 8 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: looking for participants now, as of the sponsor's last update on 5 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas J Hawke, PhD (905-525-9140 ext. 22372, hawke@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description) (time frame: At time of study start (baseline characteristics)). 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 NCT05740514, 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 Dec 2024.