High-Intensity Interval Training for Type 2 Diabetes

(FHT HIIT Trial)

Overseen By Michael Fernando, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Pregnant, Myocardial infarction, 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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a high-intensity interval training program, delivered through virtual care, in managing type 2 diabetes compared to regular exercise guidelines. It tests whether short bursts of intense exercise can better control blood sugar levels (measured by hemoglobin A1C) and reduce weight. Participants will either follow a specific high-intensity exercise plan or receive general exercise advice. This trial suits adults diagnosed with type 2 diabetes who can safely exercise and have not had a recent heart attack. As an unphased trial, it offers a unique opportunity to contribute to innovative diabetes management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that High-Intensity Interval Training is safe for individuals with Type 2 Diabetes?

Research has shown that high-intensity interval training (HIIT) is generally safe for people with type 2 diabetes. Studies have found that HIIT can help control blood sugar levels and improve heart health.

Previous studies report that most people tolerate HIIT well, with few adverse side effects. Many individuals with type 2 diabetes have experienced improvements in how their bodies handle sugar and fat, including better results in tests like HbA1c, which measures average blood sugar over time.

Overall, HIIT appears to be a safe and effective exercise choice for people with type 2 diabetes. However, as with any new exercise routine, starting slowly and consulting a healthcare provider if there are any concerns is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-intensity interval training (HIIT) for managing Type 2 Diabetes because it offers a fresh approach compared to traditional methods like medication and standard aerobic exercise. Unlike typical physical activity regimens, HIIT involves short bursts of intense effort followed by rest, which can be more effective in improving insulin sensitivity and cardiovascular health in less time. This makes HIIT a potentially more engaging and time-efficient option for patients. Additionally, the self-directed nature of the HIIT protocol empowers individuals to manage their own routines, fostering a sense of control and personal responsibility in their health journey.

What evidence suggests that High-Intensity Interval Training could be an effective treatment for Type 2 Diabetes?

Research has shown that high-intensity interval training (HIIT), included in the physical activity advice for participants in one arm of this trial, can greatly improve blood sugar control and heart health in people with type 2 diabetes. Studies have found that HIIT lowers hemoglobin A1C levels, a measure of average blood sugar over time, and enhances heart and lung fitness more effectively than other types of exercise. HIIT also aids the body in managing sugar and fat, crucial for diabetes control. In some cases, completing 48 HIIT sessions over 16 weeks significantly lowered fasting blood sugar levels. These findings suggest that HIIT could be a powerful method for managing type 2 diabetes. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 2 diabetes who can safely exercise and have their doctor's (Dr. Fernando) approval. They must be able to consent and should not be pregnant or have had a heart attack in the last three months.

Inclusion Criteria

Non-pregnant

Deemed capable and safe to exercise by their physician (Dr. Fernando)

I have not had a heart attack in the last three months.

Exclusion Criteria

I do not have type 2 diabetes.

Pregnant

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Data collection at baseline including weight, height, minutes of PA, HbA1C, and medication review

1 week

1 visit (virtual)

Intervention

Participants follow either a high-intensity interval training (HIIT) or population-based physical activity protocol

6 months

Self-directed with virtual support

Follow-up

Participants are monitored for changes in HbA1C, weight, and physical activity at 3-month and 6-month intervals

6 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• High-Intensity Interval Training Physical Activity (PA) Advice

Trial Overview The study tests if virtual care can effectively prescribe short, intense workouts to manage type 2 diabetes better than the standard advice of getting at least 150 minutes of physical activity per week.

How Is the Trial Designed?

Group I: High-Intensity Interval Training Physical Activity (PA) Advice Experimental Treatment 1 Intervention

This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a High-Intensity-Interval-Training (HIIT) handout (developed based on research from Dr. Martin Gibala) detailing their PA recommendations. Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone.

Group II: Population-Based Physical Activity (PA) Advice Active Control 1 Intervention

This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a CSEP handout (page 4\&5 from: http://csep.ca/CMFiles/Guidelines/CSEP\_PAGuidelines\_0-65plus\_en.pdf) detailing their PA recommendations.Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

East Elgin Family Health Team

Collaborator

Trials

2

Recruited

220+

Published Research Related to This Trial

A scoping review of 69 studies on high-intensity interval training (HIIT) in older adults found that HIIT protocols are generally well-tolerated and can provide significant health benefits, particularly in improving cardiorespiratory fitness.

Most research has focused on healthy older adults, highlighting a need for larger studies and more investigation into HIIT's effects on older adults with various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. Marriott, CFS., Petrella, AFM., Marriott, ECS., et al.[2021]

A 6-week high-intensity interval training (HIT) program, requiring less than 15 minutes per session, significantly improved key health markers in 189 sedentary adults with pre-existing risk factors for type 2 diabetes, including a 10% increase in fitness levels and a 16% reduction in insulin resistance.

The HIT protocol also effectively lowered mean arterial blood pressure by 3%, demonstrating that this time-efficient exercise regimen can be as effective as longer, traditional exercise programs in managing cardio-metabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Practical and Time-Efficient High-Intensity Interval Training Program Modifies Cardio-Metabolic Risk Factors in Adults with Risk Factors for Type II Diabetes. Phillips, BE., Kelly, BM., Lilja, M., et al.[2019]

A 12-week high-intensity interval training (HIIT) program significantly reduced heart rate at the onset and during specific intervals of exercise in patients with type 2 diabetes and hypertension, indicating improved cardiovascular efficiency.

Participants who adhered to the HIIT program experienced a notable decrease in heart rate during exercise intervals, suggesting enhanced cardiovascular recovery, while no significant changes were observed in body mass index or blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiovascular recovery during intermittent exercise in highly-adherent partic pants with hypertension and type 2 diabetes mellitus]. Cano-Montoya, J., Álvarez, C., Martínez, C., et al.[2017]

High-intensity aerobic interval training (HAIT) significantly improved aerobic fitness, as shown by a 21% increase in VO2max and a reduction in HbA1c by 0.58% in individuals with type 2 diabetes over 12 weeks.

HAIT also led to a reduction in body weight and body mass index, demonstrating its effectiveness in addressing multiple risk factors associated with type 2 diabetes compared to moderate-intensity training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity aerobic interval training improves aerobic fitness and HbA1c among persons diagnosed with type 2 diabetes. Støa, EM., Meling, S., Nyhus, LK., et al.[2022]

High-intensity training has been shown to significantly improve metabolic parameters in patients with pre-diabetes and type 2 diabetes, highlighting the importance of exercise therapy for glycemic control.

For patients unable to engage in traditional exercise due to complications, non-exercise activity thermogenesis (NEAT) can be beneficial, providing an alternative way to enhance metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Therapy for Patients With Type 2 Diabetes: A Narrative Review. Yanai, H., Adachi, H., Masui, Y., et al.[2020]

High-intensity interval training (HIIT) has been shown to significantly improve various health outcomes, including cardiorespiratory fitness, muscle mass, and mental health indicators like anxiety and depression, across diverse populations, as evidenced by 33 systematic reviews involving both healthy individuals and those with health complications.

HIIT is considered safe, with no reported acute injuries and high adherence rates exceeding 80%, suggesting it is a feasible exercise option for many people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. Martland, R., Mondelli, V., Gaughran, F., et al.[2023]

High-intensity interval training (HIIT) significantly improved glycemic control and cardiorespiratory fitness in patients with type 2 diabetes, showing reductions in body fat, hemoglobin A1c, and increased VO2peak compared to moderate-intensity training (MICT) and no training.

In a systematic review of 13 trials with 345 participants, HIIT led to greater reductions in body weight and body mass index than MICT, indicating that HIIT may be a more effective exercise strategy for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of high-intensity interval training on glycemic control and cardiorespiratory fitness in patients with type 2 diabetes: a systematic review and meta-analysis. Liu, JX., Zhu, L., Li, PJ., et al.[2022]

High-intensity interval training (HIIT) and sprint interval training (SIT) can significantly improve glycemic control in individuals with metabolic syndrome (MetS) and type 2 diabetes (T2D), potentially more effectively than traditional aerobic exercise.

These interval training methods require less time commitment, addressing common barriers to regular exercise, making them a practical option for enhancing glucose metabolism in patients with MetS and T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of high-intensity interval training and sprint interval training on peripheral markers of glycemic control in metabolic syndrome and type 2 diabetes. Jiménez-Maldonado, A., García-Suárez, PC., Rentería, I., et al.[2022]

A systematic review of 11 studies involving 156 clinically stable patients with cardiometabolic diseases found that high-intensity interval exercise (HIIE) can lead to adverse responses in about 8% of individuals, indicating a higher risk compared to moderate-intensity exercise.

It is recommended that patients with cardiometabolic diseases who wish to engage in HIIE should be clinically stable, have prior experience with moderate-intensity exercise, and exercise under supervision to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. Levinger, I., Shaw, CS., Stepto, NK., et al.[2022]

Sprint interval training (SIT) and combined aerobic + resistance training (COMB) significantly reduced HbA1c levels in participants with type 2 diabetes, with SIT showing a reduction of -1.82% and COMB -1.24% over 10 weeks, compared to no change in the control group.

Both SIT and COMB also led to significant improvements in insulin sensitivity, as indicated by reductions in HOMA-IR, with SIT showing a decrease of -4.89 and COMB -2.90, highlighting their efficacy as exercise interventions for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sprint interval training vs. combined aerobic + resistance training in overweight women with type 2 diabetes. Banitalebi, E., Mardaniyan Ghahfarrokhi, M., Faramarzi, M., et al.[2022]

Both low volume high intensity interval exercise (HIIE) and extremely low volume sprint interval exercise (SIE) improved aerobic capacity in individuals with type 2 diabetes, with HIIE showing a greater improvement in VO2peak and body fat percentage.

Despite these improvements in exercise capacity, neither HIIE nor SIE led to significant changes in glycemic control (HbA1c), suggesting that longer or more intensive exercise interventions may be necessary to impact blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Time Efficient Exercise Improve Cardiometabolic Risk Factors in Type 2 Diabetes? A Pilot Study. Revdal, A., Hollekim-Strand, SM., Ingul, CB.[2022]

A 12-week study involving 15 participants with type 2 diabetes showed that high intensity interval exercise (HI-IE) is as feasible as moderate intensity continuous exercise (MI-CE), with both groups maintaining high adherence rates of over 97%.

Both HI-IE and MI-CE effectively reduced total body fat and trunk fat, but neither intervention significantly changed glycated hemoglobin A1c (HbA1c) levels, indicating limited impact on blood sugar control in participants who were already well-managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of high intensity interval training in type 2 diabetes. Terada, T., Friesen, A., Chahal, BS., et al.[2022]

Citations

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Effectiveness and Safety of High-Intensity Interval Training ... IN BRIEF Recent research has shown that high-intensity interval training (HIIT) can promote improvements in glucose control and cardiovascular health in ...

2. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16220

Efficacy of high‐intensity interval training in individuals with ... The data indicated that HIIT significantly improves glycosylated haemoglobin and cardiorespiratory fitness compared with CON (weighted mean ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39910758/

An umbrella review of systematic reviews and meta-analyses The data indicated that HIIT significantly improves glycosylated haemoglobin and cardiorespiratory fitness compared with CON (weighted mean difference [WMD]: - ...

4. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1360998/full

Effects of high-intensity intermittent exercise on glucose ... Conclusions: HIIT has been shown to improve glucose and lipid metabolism in patients with type 2 diabetes, especially in HbA1c, TC, TG, and HDL.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0925443920301654

Impact of high-intensity interval training and sprint ... In line with the previous report, other studies showed that 48 sessions of HIIT (jogging/running) over 16 weeks reduced FPG in adults with T2D [118]. Finally, ...

6. diabetesjournals.org diabetesjournals.org/spectrum/article-abstract/28/1/39/32129/Effectiveness-and-Safety-of-High-Intensity

Effectiveness and Safety of High-Intensity Interval Training in ... Recent research has shown that high-intensity interval training (HIIT) can promote improvements in glucose control and cardiovascular health in individuals ...

7. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-025-01909-z

Comparative effectiveness of high-intensity interval training ... To evaluate the effects of high-intensity interval training (HIIT) on cardiometabolic health-related outcomes in patients with type 2 diabetes ...