168 Participants Needed

Exercise for Type 1 Diabetes

(HOME T1D Trial)

TJ
IA
Overseen ByIrena A Rebalka, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use anti-inflammatory, glucocorticoid, or other pain-relief medications regularly.

What data supports the effectiveness of the treatment 'Exercise for Type 1 Diabetes'?

Research shows that exercise can improve insulin sensitivity, reduce the need for insulin, and help manage heart and nerve function in people with type 1 diabetes. Additionally, intense physical activity is linked to better blood sugar control, and adding resistance training to aerobic exercise may further improve health outcomes.12345

Is exercise safe for people with type 1 diabetes?

Exercise is generally safe for people with type 1 diabetes, but there is a risk of hypoglycemia (low blood sugar) during and after exercise. Strategies like glucose monitoring and insulin pump therapy can help manage this risk, allowing safe participation in physical activities.678910

How does exercise as a treatment for type 1 diabetes differ from other treatments?

Exercise is a unique treatment for type 1 diabetes because it is a non-drug approach that can improve insulin sensitivity, reduce insulin requirements, and enhance cardiovascular health. Unlike medications, exercise also offers psychological benefits and can be tailored to minimize the risk of low blood sugar episodes, making it a versatile and holistic option for managing the condition.111121314

What is the purpose of this trial?

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.

Research Team

TJ

Thomas J Hawke, PhD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for adults aged 18-30 or 45-65 with Type 1 Diabetes who are not very active, doing less than the recommended amount of weekly exercise. It's not for those hospitalized multiple times for diabetic ketoacidosis, on certain medications, overweight (BMI >30), recent users of cannabis/tobacco/nicotine, or with other health issues that make exercising risky.

Inclusion Criteria

I am either 18-30 or 45-65 years old.
You do not engage in at least 150 minutes of moderate-to-vigorous physical activity each week.

Exclusion Criteria

You have health problems that make it risky for you to take part in the study's exercise activities.
I have been diagnosed with prediabetes.
I have a specific type of nerve damage due to diabetes.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial physiological assessments to evaluate muscle health and establish baseline characteristics

At time of study start

Twelve-week Exercise

Participants undergo a combined aerobic and resistance training program

12 weeks
Regular visits for exercise sessions and monitoring

Detraining

Participants undergo a seven-day detraining period with unilateral knee immobilization

1 week
1 visit for immobilization setup

Four-week Re-training

Participants resume exercise program consisting of aerobic and resistance exercise

4 weeks
Regular visits for exercise sessions and monitoring

Follow-up

Participants are monitored for changes in muscle health and physiological parameters

4 weeks
2 visits for assessments

Treatment Details

Interventions

  • De-training
  • Exercise
Trial Overview The study looks at how Type 1 Diabetes affects muscle and blood vessels in men and women over time. It will test the effects of starting an exercise program and then stopping it ('de-training') to see what happens to their muscles and insulin sensitivity.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Twelve-week ExerciseExperimental Treatment1 Intervention
Study participants will participate in an exercise program consisting of aerobic and resistance exercise. This arm will last twelve weeks.
Group II: One-week DetrainingExperimental Treatment1 Intervention
Study participants will undergo unilateral knee immobilization for a one-week period.
Group III: Four-week Re-trainingExperimental Treatment1 Intervention
Study participants will once again participate in an exercise program consisting of aerobic and resistance exercise. This arm will last four weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Findings from Research

Exercise training significantly improves insulin sensitivity in patients with type 1 diabetes mellitus (T1DM), which can lead to a reduced need for insulin and better overall management of the condition.
Regular physical activity also helps mitigate autonomic and cardiovascular dysfunction in T1DM patients, highlighting the importance of incorporating exercise into their treatment plans.
[Physiological effects of exercise training in patients with type 1 diabetes].De Angelis, K., da Pureza, DY., Flores, LJ., et al.[2022]
Exercise training in adults with type 1 diabetes led to significant improvements in body mass, body mass index (BMI), peak oxygen uptake (Peak VO2), and low-density lipoprotein (LDL) cholesterol, indicating enhanced physical health and metabolic control.
In children with type 1 diabetes, exercise resulted in reduced insulin doses, waist circumference, LDL cholesterol, and triglycerides, suggesting that physical activity can positively influence diabetes management in younger populations.
Clinical outcomes to exercise training in type 1 diabetes: A systematic review and meta-analysis.Ostman, C., Jewiss, D., King, N., et al.[2018]
In a study of 130 adult patients with type 1 diabetes, those who engaged in more than 150 minutes of intense physical activity per week had significantly lower HbA1c levels, indicating better metabolic control.
No significant improvements in metabolic control were observed for patients who participated in moderate physical activity, suggesting that intense exercise may be more beneficial for managing blood sugar levels in type 1 diabetes.
Intense physical activity is associated with better metabolic control in patients with type 1 diabetes.Carral, F., Gutiรฉrrez, JV., Ayala, Mdel C., et al.[2018]

References

[Physiological effects of exercise training in patients with type 1 diabetes]. [2022]
Clinical outcomes to exercise training in type 1 diabetes: A systematic review and meta-analysis. [2018]
Intense physical activity is associated with better metabolic control in patients with type 1 diabetes. [2018]
Resistance Exercise in Already-Active Diabetic Individuals (READI): study rationale, design and methods for a randomized controlled trial of resistance and aerobic exercise in type 1 diabetes. [2022]
A Systematic Review of Physical Activity and Exercise on Physiological and Biochemical Outcomes in Children and Adolescents With Type 1 Diabetes. [2020]
Physical Activity in Youth With Type 1 Diabetes: a Review. [2018]
Exercise strategies for hypoglycemia prevention in individuals with type 1 diabetes. [2022]
Why should people with type 1 diabetes exercise regularly? [2022]
Exercise modes and their association with hypoglycemia episodes in adults with type 1 diabetes mellitus: a systematic review. [2022]
No Disadvantage to Insulin Pump Off vs Pump On During Intermittent High-Intensity Exercise in Adults With Type 1 Diabetes. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Exercise for type 1 diabetes mellitus management: General considerations and new directions. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Exercise interventions for patients with type 1 diabetes mellitus: A narrative review with practical recommendations. [2023]
Cardiovascular Health Benefits of Exercise Training in Persons Living with Type 1 Diabetes: A Systematic Review and Meta-Analysis. [2020]
Exercise management in type 1 diabetes: a consensus statement. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity