Exercise for Type 2 Diabetes

Recruiting at 2 trial locations

Overseen By Steven K Malin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Metformin, GLP-1 agonists

Must not be taking: Vasoactive medications

Disqualifiers: Morbid obesity, Hypertension, Smoking, 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

Duration: 16 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how exercise affects blood flow and metabolic health in people with type 2 diabetes, focusing on tiny particles called extracellular vesicles (EVs) that may influence heart health. The researchers will determine if exercise can alter how EVs impact individuals with type 2 diabetes, potentially aiding in the development of better treatments for heart disease linked to diabetes. Ideal participants include those with type 2 diabetes who are overweight and not currently exercising more than 150 minutes a week. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to improved heart health treatments for those with 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, but it excludes participants who are taking certain medications like vasoactive drugs. If you're on medications like metformin or GLP-1 agonists, you must have been on them for at least a year to participate.

What prior data suggests that exercise is safe for people with type 2 diabetes?

Research has shown that exercise is generally safe and beneficial for people with type 2 diabetes. Studies indicate that various types of exercise, such as aerobic activities (like walking or cycling) and resistance training (like lifting weights), can enhance strength, lower blood pressure, and improve insulin use. This is crucial for managing diabetes.

For individuals with obesity who have normal blood sugar levels, exercise remains safe and advantageous. Regular aerobic exercise can reduce body fat and waist size, enhancing overall health and lowering the risk of heart and blood vessel issues.

These findings suggest that exercise is a safe and effective way to improve health for both groups. Reports of serious side effects are rare, making it a promising option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise as a treatment for type 2 diabetes because it provides a non-pharmaceutical approach that can enhance overall health while managing the condition. Unlike current treatments like metformin or insulin, which focus on regulating blood sugar levels through medication, exercise improves insulin sensitivity and glucose metabolism naturally. Additionally, engaging in regular, high-intensity workouts, as proposed in this trial, can help with weight management and cardiovascular health, which are crucial for individuals with diabetes. By potentially reducing reliance on medications, this approach offers a holistic way to manage diabetes and improve quality of life.

What evidence suggests that exercise might be an effective treatment for type 2 diabetes?

This trial will evaluate the effects of exercise on different participant groups. Studies have shown that exercise can be very effective for people with type 2 diabetes. Participants with obesity and type 2 diabetes in this trial will engage in supervised exercise sessions. Regular aerobic exercise, like walking or cycling, helps control blood sugar levels. Strength exercises, such as weight lifting, improve how the body uses insulin, which is important for managing blood sugar. Research also shows that exercise aids weight loss and improves how the body processes fat in people with obesity. Overall, exercise is an important tool for managing both type 2 diabetes and obesity. ^{2 4 6 7 8}

Who Is on the Research Team?

Steven K Malin, PhD

Principal Investigator

Rutgers University - New Brunswick

Are You a Good Fit for This Trial?

This trial is for individuals with Type 2 Diabetes and obesity, aiming to understand how extracellular vesicles (EVs) affect cardiovascular disease related to diabetes. Participants should be interested in how exercise might influence their blood flow and metabolic health.

Inclusion Criteria

Not currently engaged in >90 min/wk of exercise

I have been diagnosed with Type 2 Diabetes or my tests show high blood sugar.

I am between 40 and 70 years old.

Exclusion Criteria

Intolerance to insulin

I have been prescribed diabetes medication in the past year.

I have type 1 diabetes and need insulin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo supervised exercise training sessions at 85% VO2max, expending approximately 400 kcal per session

16 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study focuses on the role of EVs in vascular insulin action and examines whether regular exercise can modify the effects of EVs on metabolism and cardiovascular health in people with Type 2 Diabetes.

How Is the Trial Designed?

Group I: Obesity with Type 2 Diabetes Experimental Treatment 1 Intervention

Participants with obesity and type 2 diabetes will participate in 3 supervised exercise training sessions at 85% VO2max that expends \~400 kcal for 16 weeks.

Group II: Obesity with Normal Glucose Tolerance Experimental Treatment 1 Intervention

Participants with obesity and normal glucose tolerance will participate in 3 supervised exercise training sessions at 85% VO2max that expends \~400 kcal for 16 weeks.

Group III: Lean with Normal Glucose Tolerance Active Control 1 Intervention

Participants will not receive the study intervention and will be healthy controls.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

Regular aerobic exercise is a safe and effective non-pharmacological treatment for type 2 diabetes, helping to improve metabolic risk factors and lower mortality risk, especially when not limited by other health issues.

Recent evidence suggests that resistance training may be even more effective than aerobic exercise for improving glycemic control in patients with type 2 diabetes, highlighting its importance in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

May the force be with you: why resistance training is essential for subjects with type 2 diabetes mellitus without complications. Codella, R., Ialacqua, M., Terruzzi, I., et al.[2019]

Exercise training is essential for preventing and managing type 2 diabetes mellitus (T2DM), as highlighted by updated guidelines from major health organizations, including the American College of Sports Medicine and the American Diabetes Association.

Individualized exercise training programs are crucial for T2DM patients, focusing on tailored aerobic and resistance training prescriptions to ensure safety and effectiveness in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Individualized exercise training prescription for patients with type 2 diabetes mellitus]. Chang, CQ.[2011]

Regular physical activity can significantly reduce the risk of developing type 2 diabetes (T2D) by 50% in individuals with high metabolic risk and improve glycemic control by lowering HbA1c levels by an average of 0.7%.

The benefits of physical activity extend beyond just one-time exercise sessions, as consistent training leads to long-term improvements in blood pressure, lipid profiles, and insulin resistance, with recommendations tailored to fit individual preferences and lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and type 2 diabetes. Recommandations of the SFD (Francophone Diabetes Society) diabetes and physical activity working group. Duclos, M., Oppert, JM., Verges, B., et al.[2013]

Regular physical exercise significantly improves glycaemic control and insulin sensitivity in individuals with type 2 diabetes, leading to better management of the condition.

Despite the known benefits of exercise, there is still uncertainty about the optimal type, frequency, and intensity of exercise for diabetic patients, which contributes to low levels of physical activity among them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity as a therapeutic tool in type 2 diabetes: the rationale]. Gautier, JF.[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]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

Exercise can greatly benefit people with diabetes, but it's crucial to measure glucose levels before starting to ensure safety during workouts.

Guidelines have been developed to help exercise specialists determine when to start or stop exercise based on glucose levels, with specific contraindications such as low glucose (<4.0 mmol/L) or high glucose (>15.0 mmol/L with symptoms).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resources to Guide Exercise Specialists Managing Adults with Diabetes. Turner, G., Quigg, S., Davoren, P., et al.[2020]

Physical activity is crucial for diabetes management, providing benefits like improved blood sugar control, reduced risk of related health issues, and enhanced quality of life for patients with both type 1 and type 2 diabetes.

Caregivers often lack knowledge about exercise recommendations for diabetic patients, which can lead to either unnecessary restrictions on physical activity or increased risk of adverse reactions; therefore, proper assessment of health conditions and safety measures is essential before starting an exercise program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise prescription for diabetics: more than a general recommendation]. Constantini, N., Harman-Boehm, I., Dubnov, G.[2008]

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]

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]

Regular physical activity is essential for managing blood glucose levels and improving overall health in individuals with diabetes, as it reduces cardiovascular risk and aids in weight loss.

A personalized exercise program that combines aerobic and resistance training can enhance the benefits of physical activity while minimizing the risk of exercise-related complications in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Individualized Exercise Prescription in Type 2 Diabetes Mellitus Management. Doupis, J., Karras, K., Avramidis, K.[2022]

Regular physical activity is crucial for individuals with type 2 diabetes, as it helps maintain improved glucose tolerance and insulin sensitivity, which can deteriorate within 72 hours after the last exercise session.

A minimum of 1,000 kcal per week from physical activities is recommended, with a focus on comfortable exercise intensity and potential modifications for those with diabetes complications, to enhance overall fitness and reduce cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American College of Sports Medicine position stand. Exercise and type 2 diabetes. Albright, A., Franz, M., Hornsby, G., 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]

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