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?

The goal of this experimental trial is to learn about the changes in bacterial diversity in individuals with type 2 diabetes who perform endurance and strength training at different intensities. Participants with type 2 diabetes will be randomly assigned to 16 weeks of either moderate-intensity endurance and strength training or high-intensity endurance and strength training. Researchers will compare the moderate-intensity and high-intensity exercise groups for differences in glycemia and bacterial diversity.

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.

Is exercise safe for people with type 2 diabetes?

Exercise is generally safe for people with type 2 diabetes if certain precautions are taken, such as adapting the exercise to individual health conditions and starting slowly. While there is a risk of minor injuries, like muscle strains, serious adverse events are rare when proper screening and gradual progression are followed. ^{1 2 3 4 5}

How is the Combined Exercise Intervention treatment unique for managing Type 2 Diabetes?

The Combined Exercise Intervention is unique because it integrates both endurance and resistance exercises tailored to individual needs, focusing on improving metabolic control and muscle strength, especially in patients with different stages of Type 2 diabetes. This personalized approach, often supervised, aims to enhance long-term health benefits and compliance, unlike standard treatments that may not offer such customization. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Combined Exercise Intervention for Type 2 Diabetes?

Research shows that physical activity is crucial for managing type 2 diabetes, improving blood sugar control, and enhancing quality of life. Exercise therapy is recognized as a key part of treatment, helping to improve heart health and overall fitness in people with type 2 diabetes. ^{7 11 12 13 14}

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 am not on medication that affects heart rate monitor accuracy.

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

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effect of psychological intervention on exercise adherence in type 2 diabetic subjects. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. France pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

Exercise therapy in type 2 diabetes. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Prevention of type II diabetes by physical training. Epidemiological considerations and study methods. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Diet and exercise in type 2 diabetes mellitus. [2019]

9. United States 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. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Revisiting the role of physical activity and exercise in the treatment of type 2 diabetes. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Optimizing the therapeutic benefits of exercise in Type 2 diabetes. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Physical activity and type 2 diabetes: tailoring exercise to optimize fitness and glycemic control. [2010]

13. Germany pubmed.ncbi.nlm.nih.gov

[Diabetes, sport and exercise]. [2012]

14. England 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. [2021]