Exercise for Type 2 Diabetes

(RESIST Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

Must be taking: Anti-diabetic medications

Must not be taking: Insulin, TZDs, GLP-1 agonists

Disqualifiers: Hypertension, Alcohol abuse, Cancer, 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: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some people with type 2 diabetes don't fully benefit from exercise. Participants will engage in aerobic exercise for ten weeks, with their results compared to a control group of young athletes. The trial targets adults with type 2 diabetes who do not follow a regular exercise program and are willing to exercise daily during the study. This research could improve exercise recommendations for those with type 2 diabetes. As an unphased trial, participants contribute to valuable research that may enhance exercise guidelines for better diabetes management.

Will I have to stop taking my current medications?

If you are currently taking anti-diabetic medications, you must be willing to stop using them for the duration of the study. If you are on other medications, the trial protocol does not specify whether you need to stop them.

What prior data suggests that exercise is safe for individuals with Type 2 Diabetes?

Research has shown that exercise is generally safe for people with type 2 diabetes. Studies indicate that regular aerobic exercise helps control blood sugar levels and improves the body's use of sugar by enhancing insulin sensitivity.

Many studies support these benefits. For instance, one study found that regular exercise, combined with some weight loss, can lower the risk of developing type 2 diabetes by up to 58% in people at high risk. Another large study demonstrated that low fitness levels are linked to a higher chance of heart disease, so being active can help reduce that risk.

Most people tolerate exercise well, and serious side effects are rare. It's a natural activity. However, consulting a doctor before starting any new exercise program is always advisable, especially for those with existing health issues. Overall, evidence supports exercise as a safe and effective way to manage type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike conventional treatments for Type 2 Diabetes, which often include medications like metformin or insulin therapy, the exercise regimen in question focuses on a non-pharmacological approach. Researchers are excited about this because aerobic exercise could improve insulin sensitivity and help manage blood sugar levels without the side effects associated with medication. Additionally, this approach promotes overall cardiovascular health and can enhance quality of life, offering a holistic benefit beyond just managing diabetes symptoms.

What evidence suggests that exercise might be an effective treatment for Type 2 Diabetes?

This trial will compare the effects of aerobic exercise with an active control group of young athletes. Research has shown that exercise can greatly benefit people with type 2 diabetes. Regular aerobic exercise, which participants in this trial will perform, helps regulate blood sugar levels, crucial for managing this condition. Studies have found that planned exercise routines increase the body's sensitivity to insulin, aiding in blood sugar control. Additionally, strength training can improve muscle strength and lower blood pressure. Overall, staying active is associated with significant health benefits for those with type 2 diabetes. ^{1 2 3 4 6}

Who Is on the Research Team?

Lauren M Sparks, PhD

Principal Investigator

Translational Research Institute for Metabolism and Diabetes

Are You a Good Fit for This Trial?

This trial is for adults aged 30-65 with Type 2 Diabetes, who are not currently exercising regularly. Participants can be on certain diabetes medications like metformin but must stop them during the study. They should have an HbA1c level that reflects moderate blood sugar control and be willing to exercise daily for the study period.

Inclusion Criteria

My HbA1c level is between 6.0% and 8.5%, or it's 8.5% or below if I'm on diabetes medication.

I am willing to stop my diabetes medication during the study.

My latest HbA1c level is between 5.7% and 8.8%, or below 8.9% if I'm on diabetes medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 10 weeks of aerobic exercise to study exercise resistance

10 weeks

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 trial is studying how exercise affects individuals with Type 2 Diabetes. Researchers want to understand why some people don't get the usual benefits from physical activity. Participants will engage in a prescribed exercise routine throughout the study.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 1 Intervention

10 weeks of aerobic exercise

Group II: Active Control Active Control 1 Intervention

Young athletes as a trained control

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials

41

Recruited

3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8802999/

Exercise/Physical Activity in Individuals with Type 2 Diabetes Resistance exercise training in adults with T2D typically results in 10-15% improvements in strength, bone mineral density, blood pressure, lipid profiles, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2992225/

Exercise and Type 2 Diabetes - PubMed Central - NIH Structured interventions combining PA and modest weight loss have been shown to lower type 2 diabetes risk by up to 58% in high-risk populations. Most benefits ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2799803

Effectiveness of a Community-Based Structured Physical ... This randomized clinical trial examines the effectiveness of providing varying frequencies of weekly structured exercise sessions to improve ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667036423000018

The importance of exercise for glycemic control in type 2 ... Habitual aerobic exercise helps manage blood glucose. Resistance exercise benefits insulin sensitivity in those with type 2 diabetes.

5. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2025.1495131/full

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 ...

6. diabetesjournals.org diabetesjournals.org/spectrum/article/18/2/88/1853/Physical-Activity-Exercise-and-Type-2-Diabetes

Physical Activity/Exercise and Type 2 Diabetes Large cohort studies showing that low aerobic fitness and low physical activity level predict increased risk of overall and cardiovascular disease(CVD) ...