Cardiovascular Exercise for Type 2 Diabetes

(REACH Trial)

Recruiting at 1 trial location

Overseen By Zhenqi Liu, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Beta blockers, Calcium channel blockers

Disqualifiers: Cardiovascular disease, Hypertension, Asthma, 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: 15 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cardiovascular exercise improves heart and muscle function in people with type 2 diabetes by enhancing insulin use. It involves two groups: participants with type 2 diabetes and healthy individuals who are overweight. The study seeks individuals who exercise less than an hour a week and have a BMI between 25 and 40. Participants should not have heart disease, asthma, or use certain medications like insulin. As an unphased trial, this study offers a unique opportunity to contribute to understanding the benefits of exercise for diabetes management.

Will I have to stop taking my current medications?

The trial requires that participants do not take certain medications, including beta blockers, calcium channel blockers, insulin, or Thiazolidinediones (TZD). If you are on these medications, you may need to stop taking them to participate.

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

Research shows that regular exercise is generally safe for people with type 2 diabetes. Studies have found that exercise helps control blood sugar levels and reduces the risk of heart disease. It also aids in weight loss and improves overall well-being.

Exercise is safe for most people and is a natural activity with rare serious side effects. Some might experience muscle soreness or tiredness, but these effects are usually mild and temporary. Large studies confirm that physical activity benefits heart health and lowers the risk of diabetes-related complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cardiovascular exercise trial for type 2 diabetes because it focuses on a non-pharmaceutical approach to managing the condition. Unlike standard treatments, such as metformin or insulin therapy, which concentrate on controlling blood sugar levels through medication, cardiovascular exercise aims to improve overall metabolic health by enhancing cardiovascular fitness. This method could lead to better long-term health outcomes, including weight management and improved insulin sensitivity, without the side effects associated with medication. Additionally, incorporating exercise as a treatment empowers patients to take an active role in managing their health, potentially leading to more sustainable lifestyle changes.

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

Research has shown that cardiovascular exercise, such as jogging or cycling, can greatly benefit people with type 2 diabetes. In this trial, participants with type 2 diabetes will engage in cardiovascular exercise to evaluate its effects. Studies have found that this type of exercise helps control blood sugar and lower blood pressure. It can also reduce waist size and improve cholesterol levels. Regular exercise strengthens the heart and reduces the risk of heart problems. Overall, exercise is a powerful way to manage type 2 diabetes and improve health. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for sedentary adults with a BMI of 25-40, who may or may not have type 2 diabetes. It's not suitable for those with uncontrolled high blood pressure, taking certain heart and diabetes medications, smokers, or people with cardiovascular disease, lung conditions like asthma, severe nerve damage in limbs (peripheral neuropathy), anemia, liver or kidney disease.

Inclusion Criteria

You do not engage in physical activity for at least 1 hour per week.

Your weight in relation to your height falls within a certain range.

I may or may not have type 2 diabetes.

Exclusion Criteria

I am currently taking medication such as beta blockers, calcium channel blockers, insulin, or TZDs.

You have smoked in the past year.

I have a physical condition that limits my ability to exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo exercise training to assess its impact on insulin resistance and muscle perfusion

15 weeks

Regular exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiovascular exercise

Trial Overview The study investigates if cardiovascular exercise can improve heart and muscle function by overcoming insulin resistance in muscles—a condition common in type 2 diabetes. Participants will undergo exercise training to see if it helps their bodies use insulin better and increases blood flow to the heart and muscles.

How Is the Trial Designed?

Group I: Type 2 Diabetes Experimental Treatment 1 Intervention

Participants aged 30-55 with type 2 diabetes

Group II: Healthy overweight control Experimental Treatment 1 Intervention

Participants aged 30-55 with BMI 25-40 without type 2 diabetes

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

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

Exercise training can significantly improve cardiovascular health in individuals with type 2 diabetes and hypertension, particularly enhancing endothelial function and left ventricular diastolic function, based on a review of various studies from 1985 to 2002.

While the evidence for exercise's impact on arterial stiffness and inflammation is less robust, it suggests that exercise also aids in reducing body fat, which in turn improves insulin sensitivity and blood pressure, indicating broader benefits beyond just glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training and the cardiovascular consequences of type 2 diabetes and hypertension: plausible mechanisms for improving cardiovascular health. Stewart, KJ.[2022]

Chronic aerobic exercise training significantly improves cardiovascular disease (CVD) risk factors in individuals with diabetes mellitus (DM), enhancing glycemic control, vascular function, and cardiorespiratory fitness.

Higher intensity and volume of aerobic exercise lead to greater improvements in lipid profiles and overall cardiovascular health, although the effects on inflammation markers require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Chronic Aerobic Exercise on Cardiovascular Risk Factors in Persons with Diabetes Mellitus. Miele, EM., Headley, SAE.[2018]

A study of 56 Japanese males with Type 2 diabetes showed they had lower exercise capacity compared to healthy individuals, with significantly reduced oxygen consumption and work rate during exercise tests.

The findings suggest that exercise prescriptions for Type 2 diabetes should be adjusted to 60% of maximum heart rate, 30% of heart rate reserve, and a rating of perceived exertion of 12, especially for older patients and those with diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-evaluation of exercise prescription for Japanese type 2 diabetic patients by ventilatory threshold. Kunitomi, M., Takahashi, K., Wada, J., et al.[2022]

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]

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]

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]

Exercise plays a crucial role in preventing and treating cardiovascular disease (CVD), type 2 diabetes (T2D), and metabolic syndrome, supported by numerous observational and intervention studies.

Both aerobic and resistance exercises provide significant health benefits and improve risk markers for CVD and T2D, regardless of weight loss, highlighting the importance of incorporating various types of physical activity into exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for prevention and treatment of cardiovascular disease, type 2 diabetes, and metabolic syndrome. Gaesser, GA.[2022]

Exercise is essential for managing diabetes and recent research is uncovering how cardiovascular fitness affects long-term diabetes management and the prevention of type 2 diabetes.

Healthcare providers have tools and guidelines to prescribe cardiovascular activities for individuals with type 2 diabetes, but the challenge remains in helping patients safely implement and maintain these exercise routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular fitness and type 2 diabetes. Mullooly, C.[2019]

In a study of 60 patients with type 2 diabetes and coronary artery disease, aerobic exercise significantly reduced plasma glucose levels, demonstrating its efficacy in managing hyperglycemia.

The study highlighted that aerobic exercise capacity was low in these patients, but using cardiopulmonary exercise testing (CPX) can help tailor effective exercise prescriptions to improve their health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Aerobic Exercise Intensity in Patients with Coronary Artery Disease and Type 2 Diabetes Mellitus. Schwaab, B., Windmöller, M., König, IR., et al.[2020]

In a study involving 52 patients with type 2 diabetes, both long interval high-intensity training (L-HIIT) and short interval high-intensity interval training (S-HIIT) significantly improved cardiorespiratory capacity (V̇O2max) more than moderate intensity continuous training (MICT).

L-HIIT specifically led to significant reductions in glycated hemoglobin (HbA1c) and resting systolic blood pressure, highlighting its potential as an effective exercise protocol for improving cardiometabolic health in individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of three different low-volume aerobic training protocols on cardiometabolic parameters of type 2 diabetes patients: A randomized clinical trial. Gentil, P., Silva, LRBE., Antunes, DE., et al.[2023]

Long-term combined aerobic and strength training programs significantly improve cardiovascular risk factors, morbidity, and mortality in patients with type 2 diabetes and heart failure.

This type of exercise training is an efficient and cost-effective therapy that should be widely offered to patients in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aerobic and strength training in patients with diabetes mellitus type 2 and heart failure]. Niederseer, D., Niebauer, J.[2021]

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/PMC3114506/

Effects of Exercise on Cardiovascular Risk Factors in Type ... Aerobic exercise alone or combined with RT improves glycemic control, SBP, triglycerides, and waist circumference.

3. mdpi.com mdpi.com/2673-4540/6/5/38

Comparative Analysis of Cardiovascular Outcomes in Type ... This systematic review aims to evaluate the effects of aerobic, resistance, and combined training on CVD in individuals with T2D.

4. diabetesjournals.org diabetesjournals.org/care/article/39/11/2065/37249/Physical-Activity-Exercise-and-Diabetes-A-Position

Physical Activity/Exercise and Diabetes: A Position Statement ... Exercise improves blood glucose control in type 2 diabetes, reduces cardiovascular risk factors, contributes to weight loss, and improves well- ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.125.325526

Epidemiology and Cardiovascular Benefits of Physical ... In this review, we focus on the beneficial effects of routine physical activity (PA) on the cardiovascular system, the different ways we can achieve and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6908414/

Physical Activity/Exercise and Diabetes: A Position ... Exercise improves blood glucose control in type 2 diabetes, reduces cardiovascular risk factors, contributes to weight loss, and improves well-being (1,2).

7. 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) ...