Exercise for Type 1 Diabetes

(HOME T1D Trial)

Overseen By Irena A Rebalka, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Anti-inflammatories, Glucocorticoids, Pain-relievers

Disqualifiers: Type 2 diabetes, Prediabetes, BMI >30, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the effects of exercise on individuals with Type 1 Diabetes (T1D) and their muscle health. Researchers seek to understand how exercise training and breaks from exercise (de-training) impact men and women with T1D differently. The study will evaluate various exercise programs to determine which improves muscle and blood vessel health, enhancing insulin sensitivity and reducing blood sugar issues. The trial seeks adults with T1D who engage in less than 150 minutes of moderate-to-vigorous exercise weekly and are not on certain medications or have specific health conditions. As an unphased trial, this study offers a unique opportunity to contribute to understanding how exercise can improve health outcomes for people with T1D.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that exercise is generally safe for people with Type 1 Diabetes (T1D). Studies indicate that aerobic exercise can improve heart and lung health, reduce insulin resistance, and improve blood fat levels. These benefits help prevent complications like heart disease.

Exercise also strengthens the immune system and enhances overall health for those with T1D. No strong evidence suggests serious negative effects when people with T1D exercise regularly. However, managing blood sugar levels carefully is important to avoid low blood sugar.

In summary, exercise is well-tolerated and beneficial for people with T1D. Following safe exercise guidelines and monitoring blood sugar levels is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of structured exercise programs on managing Type 1 Diabetes, which traditionally relies on insulin therapy and dietary management. Unlike conventional treatments, this trial examines how different exercise regimens—ranging from a short detraining period to extended aerobic and resistance training—might influence blood sugar control, muscle strength, and overall health. By investigating these specific exercise protocols, researchers hope to uncover how physical activity can complement existing therapies, potentially leading to more holistic and personalized diabetes management strategies.

What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?

Research shows that exercise can greatly benefit people with Type 1 Diabetes (T1D). Activities like aerobic and resistance training make the body more responsive to insulin, enhancing its effectiveness. Exercise also increases the number of mitochondria, the energy producers in cells, leading to higher energy levels and better muscle function. Studies have found that exercise aids in weight loss and lowers the risk of heart disease. Additionally, physical activity can reduce the amount of insulin needed and improve overall fitness and health in adults with T1D. These benefits suggest that exercise is a promising way to manage T1D complications and enhance quality of life. This trial will explore these benefits further by comparing different exercise regimens, including a twelve-week exercise program and a four-week re-training program, against a one-week detraining period. ^{1 6 7 8 9}

Who Is on the Research Team?

Thomas J Hawke, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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

I have been diagnosed with prediabetes.

You have health problems that make it risky for you to take part in the study's exercise activities.

I have a specific type of nerve damage due to diabetes.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Twelve-week Exercise Experimental Treatment 1 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 Detraining Experimental Treatment 1 Intervention

Study participants will undergo unilateral knee immobilization for a one-week period.

Group III: Four-week Re-training Experimental Treatment 1 Intervention

Study participants will once again participate in an exercise program consisting of aerobic and resistance exercise. This arm will last four weeks.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Exercise training, particularly a combination of strength exercises and high-intensity interval training, may help reduce the risk of hypoglycemia in individuals with Type 1 diabetes mellitus (T1DM) compared to continuous aerobic exercise.

This proposed training regimen, performed three times a week, aims to improve long-term health markers and reduce the risk of complications associated with T1DM by enhancing glycemic control and overall physical fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for type 1 diabetes mellitus management: General considerations and new directions. Farinha, JB., Krause, M., Rodrigues-Krause, J., et al.[2022]

Regular exercise is crucial for individuals with type 1 diabetes as it can enhance overall health, improve body composition, and help achieve glycaemic control, yet many do not engage in sufficient physical activity due to various barriers.

This review offers updated guidelines on managing exercise for those with type 1 diabetes, including recommended glucose targets and necessary adjustments in nutrition and insulin doses to prevent complications like hypoglycaemia during physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise management in type 1 diabetes: a consensus statement. Riddell, MC., Gallen, IW., Smart, CE., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physiological effects of exercise training in patients with type 1 diabetes]. De Angelis, K., da Pureza, DY., Flores, LJ., et al.[2022]

The READI trial involved 131 physically active adults with type 1 diabetes and aimed to determine if adding a 6-month resistance training program would improve glycemic control compared to aerobic exercise alone.

This study is significant as it is the first to assess the additional health benefits of resistance training in individuals with type 1 diabetes who are already engaged in aerobic exercise, potentially influencing future exercise recommendations for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Yardley, JE., Kenny, GP., Perkins, BA., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense physical activity is associated with better metabolic control in patients with type 1 diabetes. Carral, F., Gutiérrez, JV., Ayala, Mdel C., et al.[2018]

A systematic review of 15 studies involving adults with type 1 diabetes found that different modes of exercise, particularly intermittent high-intensity exercise (IHE), did not significantly differ in their effects on hypoglycemia compared to continuous exercise.

While IHE may be safer due to a lesser decline in blood glucose levels, more research is needed to confirm whether this translates to fewer hypoglycemic episodes during or after exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise modes and their association with hypoglycemia episodes in adults with type 1 diabetes mellitus: a systematic review. Hasan, S., Shaw, SM., Gelling, LH., et al.[2022]

In a study involving 12 adults with type 1 diabetes, exercising with the insulin pump turned off resulted in higher blood glucose levels at the start of high-intensity exercise compared to when the pump was on, but both conditions had similar glucose levels by the end of the exercise.

There was no significant difference in the incidence of hypoglycemia during the exercise between the two conditions, but participants were better at estimating their glucose levels when the pump was on, suggesting improved awareness of their glycemic status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No Disadvantage to Insulin Pump Off vs Pump On During Intermittent High-Intensity Exercise in Adults With Type 1 Diabetes. Zaharieva, DP., Cinar, A., Yavelberg, L., et al.[2020]

A systematic review of 24 studies found that exercise training significantly improves cardiovascular risk factors in individuals with type 1 diabetes, including increased aerobic power and reduced levels of glycated hemoglobin (HbA1c) and daily insulin dosage.

Exercise training was associated with a better lipid profile, as indicated by a decrease in total cholesterol, but did not consistently affect body mass index, blood pressure, or other cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Health Benefits of Exercise Training in Persons Living with Type 1 Diabetes: A Systematic Review and Meta-Analysis. Wu, N., Bredin, SSD., Guan, Y., et al.[2020]

Exercise offers significant protective health benefits for individuals with type 1 diabetes, yet many do not meet recommended activity levels due to concerns about blood glucose management and hypoglycemia.

Advancements in glucose monitoring and insulin pump therapy have improved the ability of people with type 1 diabetes to engage in regular physical activity, and new training methods show promise in enhancing these benefits beyond just insulin regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why should people with type 1 diabetes exercise regularly? Codella, R., Terruzzi, I., Luzi, L.[2022]

Regular moderate to vigorous physical activity (MVPA) is more effective than habitual physical activity in improving body fat and cardiorespiratory fitness in children and adolescents with type 1 diabetes (T1D), based on a systematic review of 27 studies.

While MVPA can enhance insulin sensitivity and reduce daily insulin requirements, the impact on glycemic control remains unclear, with observational studies showing benefits while most interventional studies did not find significant associations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Physical Activity and Exercise on Physiological and Biochemical Outcomes in Children and Adolescents With Type 1 Diabetes. Aljawarneh, YM., Wardell, DW., Wood, GL., et al.[2020]

Anaerobic exercises, such as resistance training and high-intensity intervals, can help prevent drops in blood glucose levels during and after physical activity for individuals with type 1 diabetes.

The effectiveness of these exercises in managing blood glucose may differ based on factors like age, sex, and fitness level, highlighting the need for personalized approaches to exercise in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise strategies for hypoglycemia prevention in individuals with type 1 diabetes. Yardley, JE., Sigal, RJ.[2022]

Regular exercise is highly beneficial for individuals with Type 1 diabetes mellitus (T1DM), helping to prevent cardiovascular diseases and improve overall well-being, yet over 60% of these individuals do not engage in regular physical activity.

To maximize the benefits and minimize risks of exercise in T1DM patients, it is essential to create tailored exercise programs that consider specific factors like exercise mode, intensity, volume, and frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions for patients with type 1 diabetes mellitus: A narrative review with practical recommendations. Martin-Rivera, F., Maroto-Izquierdo, S., García-López, D., et al.[2023]

Regular physical activity is crucial for youth with type 1 diabetes to prevent cardiovascular disease and maintain good blood sugar control, yet families often face barriers such as fear of hypoglycemia.

Healthcare providers should actively encourage at least 60 minutes of physical activity three times a week for children with type 1 diabetes, emphasizing the health and psychosocial benefits to help overcome these barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity in Youth With Type 1 Diabetes: a Review. Tully, C., Aronow, L., Mackey, E., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6908414/

Physical Activity/Exercise and Diabetes: A Position ... Aerobic training increases mitochondrial density, insulin sensitivity, oxidative enzymes, compliance and reactivity of blood vessels, lung function, immune ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/10/1719/163447/Physical-Activity-Support-Can-Improve-Outcomes-in

Physical Activity Support Can Improve Outcomes in Youth ... Physical activity is associated with improved glycemic outcomes in newly diagnosed youth with type 1 diabetes: 4T Exercise Program . Diabetes ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12044773/

Quality of life and physical activity in type 1 diabetes - PMC The benefits of physical activity on quality of life in children with T1D is unclear with confounding effects of disease duration and co-morbidities in studies.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168822717311087

Clinical outcomes to exercise training in type 1 diabetes Exercise training improves some markers of type 1 diabetes severity; particularly body mass, BMI, Peak VO2 and LDL in adults and insulin dose, waist ...

5. mdpi.com mdpi.com/2227-9032/13/3/246

The Effects of Exercise Training on Body Composition and ... Conclusions: In patients with T1D, exercise training is effective for decreasing body weight and cardiometabolic risk factors. Keywords: type 1 diabetes; ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6508986/

Feasibility and Safety of a Group Physical Activity Program ... Many adolescents with type 1 diabetes do not achieve 60 minutes of daily moderate to vigorous physical activity (MVPA). Recognizing the importance of peer ...

7. diabetesjournals.org diabetesjournals.org/clinical/article/43/3/378/157802/Are-Regular-Aerobic-Exercisers-With-Type-1

Are Regular Aerobic Exercisers With Type 1 Diabetes ... This study surveyed 102 adults with type 1 diabetes who were a part of online communities for regular exercisers with type 1 diabetes.

8. wjgnet.com wjgnet.com/1948-9358/full/v13/i3/161.htm

Protective effects of physical activity against health risks ... Farinha et al[9] demonstrated that exercise training improves the body's defense systems and metabolic health in T1DM patients and induces ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213858717300141

Exercise management in type 1 diabetes: a consensus ... This Review provides an up-to-date consensus on exercise management for individuals with type 1 diabetes who exercise regularly.