Exercise for Type 2 Diabetes

(GUTFIT Trial)

Overseen By Martin Senechal, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of New Brunswick

Must not be taking: Heart rate affecting

Disqualifiers: Regular exercise, Cardiovascular disease, 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: Unknown

Duration: 16 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different types of exercise impact people with type 2 diabetes. Participants will engage in either moderate or high-intensity endurance and strength training for 16 weeks as part of a Combined Exercise Intervention. Researchers will compare these exercise routines to assess their effects on blood sugar levels and gut bacteria diversity. People with type 2 diabetes who aren't currently very active and have stable medication routines might be a good fit for this trial.

As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance exercise recommendations for managing type 2 diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not have changed your diabetes medications in the last three months to be eligible.

What prior data suggests that this exercise intervention 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. One study found that a specific HIIT routine, which includes short bursts of intense activity, was effective and well-tolerated. It improved blood sugar control and heart and lung fitness without causing significant side effects. Another study confirmed these results, showing similar improvements in blood sugar management and body composition over eight weeks.

Moderate-intensity exercise is also commonly recommended for those with type 2 diabetes. Regular moderate exercise has been shown to lower blood sugar levels, improve insulin use, and reduce blood pressure. It is considered safe and beneficial, with guidelines suggesting at least 150 minutes per week.

Both high-intensity and moderate-intensity exercises have proven safe and effective for managing type 2 diabetes. Participants in studies handled these exercises well, and no major safety issues were reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different intensities of exercise can help manage Type 2 Diabetes, potentially offering a natural and cost-effective alternative to medication. Unlike standard treatments that rely heavily on drugs to control blood sugar levels, this approach focuses on high-intensity and moderate-intensity aerobic and strength training exercises to improve insulin sensitivity and overall metabolic health. By comparing these two intensities, the trial aims to find out which is more effective, paving the way for personalized exercise recommendations as a primary strategy for diabetes management.

What evidence suggests that this trial's exercise interventions could be effective for type 2 diabetes?

Research has shown that combining different types of exercise can greatly benefit people with type 2 diabetes. Studies indicate that it helps control blood sugar, aids in weight loss, and enhances the body's use of insulin, thereby managing blood sugar levels more effectively. Exercise also improves cholesterol and overall health. In this trial, participants will follow different exercise regimens. Some will perform high-intensity aerobic and strength training exercises, while others will engage in moderate-intensity exercises. Some research suggests that high-intensity exercise can be as effective as moderate-intensity exercise for improving blood sugar and fat levels. Overall, regular combined exercise offers a promising way to support better health in type 2 diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Martin Senechal, Ph.D.

Principal Investigator

University of New Brunswick

Are You a Good Fit for This Trial?

Adults aged 19-64 with type 2 diabetes, not very active (less than 10,000 steps per day), stable on their current diabetes medications for the last three months, and have an HbA1c level of at least 7.5%. They should also be falling short of recommended physical activity levels.

Inclusion Criteria

My diabetes medication has been the same for the last 3 months.

I have been diagnosed with type 2 diabetes.

I walk less than 10,000 steps daily on average.

Exclusion Criteria

I have a condition that affects my red blood cells, like sickle cell.

I have a heart condition that makes it unsafe for me to exercise.

I have low iron or anemia, or am being treated for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a supervised exercise intervention of resistance and aerobic training for 16 weeks, performed at either high or moderate intensity

16 weeks

Regular supervised exercise sessions

Follow-up

Participants are monitored for changes in glycemic control and gut microbiome diversity after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Combined Exercise Intervention

Trial Overview The trial is testing how different exercise intensities affect gut bacteria and blood sugar control in people with type 2 diabetes. Participants will do either moderate or high-intensity endurance and strength training for 16 weeks to see which is more effective.

How Is the Trial Designed?

Group I: High intensity Experimental Treatment 1 Intervention

Participants will perform high-intensity aerobic and strength training exercises.

Group II: Moderate Intensity Active Control 1 Intervention

Participants will perform moderate-intensity aerobic and strength training exercises.

Who Is Running the Clinical Trial?

University of New Brunswick

Lead Sponsor

Trials

25

Recruited

2,700+

Laval University

Collaborator

Trials

439

Recruited

178,000+

Published Research Related to This Trial

Regular physical exercise is crucial for both preventing and treating type 2 diabetes, leading to benefits such as improved insulin sensitivity, better glycemic control, and enhanced cardiovascular health.

Before starting an exercise program, individuals with type 2 diabetes should undergo a thorough medical evaluation to assess their cardiovascular health and any complications, ensuring a safe and effective exercise plan that gradually increases in intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and exercise in type 2 diabetes mellitus. Hamdy, O., Goodyear, LJ., Horton, ES.[2019]

Structured endurance exercise can significantly improve glycemic control, insulin sensitivity, and cardiovascular risk factors in individuals with Type 2 diabetes, showing effects comparable to standard medications.

While exercise is beneficial, adherence to structured programs can be challenging, and more research is needed to understand the impact of lifestyle-based physical activity and the specific types and amounts of exercise that are most effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting the role of physical activity and exercise in the treatment of type 2 diabetes. Tudor-Locke, CE., Bell, RC., Meyers, AM.[2019]

Both endurance and resistance exercises are equally effective in improving metabolic control for patients with Type 2 diabetes, highlighting the importance of incorporating both types into treatment plans.

Exercise interventions should be tailored to individual patient needs, considering factors like disease stage and fitness level, to maximize benefits and ensure long-term adherence to the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the therapeutic benefits of exercise in Type 2 diabetes. Praet, SF., van Loon, LJ.[2022]

Physical activity is crucial for managing type 2 diabetes, improving metabolic control and quality of life for patients.

Successful physical activity interventions require assessing patients' physical capabilities and motivations, setting clear goals, and regularly adapting plans to fit their needs and support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity as a therapeutic tool in type 2 diabetes: practical aspects]. Oppert, JM.[2019]

Regular physical activity can significantly reduce insulin resistance, helping to prevent and manage type 2 diabetes mellitus.

Before starting an exercise program, patients with type 2 diabetes should undergo a clinical assessment, especially those over 35 or with additional cardiovascular risks, to ensure safety and effectiveness in their exercise regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and type 2 diabetes: tailoring exercise to optimize fitness and glycemic control. Bhaskarabhatla, KV., Birrer, R.[2010]

Physical activity plays a crucial role in the management of type 2 diabetes, highlighting the need for exercise as part of a comprehensive treatment plan.

To effectively motivate patients, healthcare providers should create personalized therapy plans that incorporate regular exercise into their daily routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diabetes, sport and exercise]. Fischer, H.[2012]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A meta-analysis of 10 randomized controlled trials involving 978 participants showed that combined exercise significantly improved glycaemic control, as indicated by a reduction in hemoglobin A1c levels by 0.16%.

Participants also experienced notable weight loss and enhanced insulin sensitivity, with reductions in body mass index and serum insulin levels, highlighting the effectiveness of combined exercise for managing type 2 diabetes in individuals with overweight or obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of combined exercise in people with type 2 diabetes and concurrent overweight/obesity: a systematic review and meta-analysis. Zhao, X., He, Q., Zeng, Y., et al.[2021]

Physical activity is a crucial and effective therapy for improving outcomes in patients with type 2 diabetes mellitus (T2DM), yet it is often underutilized due to inadequate emphasis from healthcare professionals.

An effective exercise prescription for T2DM should be personalized, considering the type, frequency, intensity, duration, and progression of activities to ensure safety and optimize patient compliance and health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise prescription and the patient with type 2 diabetes: a clinical approach to optimizing patient outcomes. Waryasz, GR., McDermott, AY.[2010]

Physical activity is crucial for preventing and managing type 2 diabetes and cardiovascular risks, but individuals with diabetes face higher risks of injury during exercise due to complications associated with the disease.

To ensure safe exercise for people with type 2 diabetes, it is important to tailor exercise programs to individual health conditions and complications, such as diabetic foot and retinopathy, while implementing preventative measures to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. Mendes, R., Sousa, N., Reis, VM., et al.[2013]

A study involving 40 newly diagnosed type 2 diabetes patients showed that combining exercise with psychological interventions significantly improved adherence to exercise programs and physiological outcomes compared to exercise alone.

The psychological component not only enhanced immediate results in body fat and strength but also led to better long-term adherence to the exercise regimen, highlighting its importance in managing type 2 diabetes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of psychological intervention on exercise adherence in type 2 diabetic subjects. Martinus, R., Corban, R., Wackerhage, H., et al.[2006]

Structured exercise is crucial for managing Type 2 diabetes, as it helps improve glycemic control and reduces cardiovascular risks, aligning with current clinical guidelines that support exercise as a therapeutic intervention.

Patients with Type 2 diabetes should engage in tailored exercise programs, with a focus on addressing cardiovascular and musculoskeletal issues, as well as motivational factors, to enhance long-term adherence and treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy in type 2 diabetes. Praet, SF., van Loon, LJ.[2021]

Physical exercise plays a crucial role in disease prevention at all levels, particularly in enhancing insulin sensitivity, which is most beneficial for primary prevention and early-stage disease management.

There is emerging evidence that exercise can improve metabolic control and may help prevent or delay complications in individuals with type II diabetes, but further trials are necessary to evaluate the long-term efficacy of exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of type II diabetes by physical training. Epidemiological considerations and study methods. King, H., Kriska, AM.[2022]

Citations

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Effectiveness of Combined Aerobic and Resistance ... Combined aerobic and resistance exercise effectively improves cognition, ameliorates metabolic health, enhances physical function, and increases physical HRQoL ...

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Effectiveness of a Community-Based Structured Physical ... The thrice-weekly exercise intervention was effective in improving HbA1c in individuals reaching at least 50% adherence to the structured ...

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Comparing the impacts of different exercise interventions ... Some studies have demonstrated that HIIT is equally effective in patients with T2DM (16), and can improve blood glucose and lipid levels in ...

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Effectiveness and Safety of High-Intensity Interval Training ... One low-volume HIIT protocol that has shown preliminary effectiveness in patients with type 2 diabetes involves 10 × 1-minute vigorous intensity efforts at ∼90% ...

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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 ...

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The importance of exercise for glycemic control in type 2 ... Recent work also shows high-intensity interval training is successful at lowering blood glucose, as is breaking up sedentary behavior with short-bouts of light ...

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Low-volume combined aerobic and resistance high ... Low-volume C-HIIT (78 min/week) and C-MICT (210 min/week) improved glycaemic control, body composition and exercise capacity similarly over 8 weeks in people ...

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Physical Activity/Exercise and Type 2 Diabetes This meta-analysis provides support for higher-intensity aerobic exercise in people with type 2 diabetes as a means of improving HbA1c. The analysis, however, ...