Aerobic Exercise for Type 2 Diabetes

(EPC-DM Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baltimore VA Medical Center

Disqualifiers: Heart disease, Stroke, 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: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aerobic exercise might improve blood vessel health in people with type 2 diabetes. Researchers examine specific cells, called endothelial progenitor cells, to determine if exercise enhances their function and overall blood sugar control. The study includes three groups: individuals with type 2 diabetes, those with normal blood sugar levels, and those with slightly elevated blood sugar. This trial may suit non-smoking, postmenopausal women or men aged 50 to 80 without heart disease, stroke history, or other serious conditions. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on exercise and diabetes management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that aerobic exercise is a safe and effective way to manage type 2 diabetes and high blood sugar levels. Studies have found that regular aerobic exercise can lower blood sugar and improve overall health for individuals with these conditions.

For those with type 2 diabetes, aerobic exercise not only helps control blood sugar but also increases the body's sensitivity to insulin, allowing more effective use of sugar. Regular exercise can reduce the risk of developing type 2 diabetes by up to 58% in high-risk individuals.

For people with high blood sugar levels, exercise can enhance fitness and muscle strength, which are linked to better blood sugar control.

Overall, aerobic exercise is safe and well-tolerated for managing blood sugar levels. It also provides additional health benefits, making it an excellent option for individuals with type 2 diabetes or high blood sugar. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about aerobic exercise training for managing Type 2 Diabetes because it offers a natural and accessible approach to improving blood sugar control. Unlike standard medications like Metformin or insulin injections, aerobic exercise enhances insulin sensitivity and glucose metabolism through physical activity, rather than pharmacological means. This treatment is distinctive because it not only targets blood sugar levels but also promotes overall cardiovascular health and can be integrated into daily routines, offering a holistic benefit that medications alone might not provide.

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

Research has shown that aerobic exercise can effectively manage type 2 diabetes. Studies have found that regular aerobic exercise lowers blood sugar levels and increases the body's insulin sensitivity. This helps control blood sugar and improves heart health. In this trial, participants with type 2 diabetes, impaired glucose tolerance, or normal glucose tolerance will engage in aerobic exercise to evaluate its effects on blood sugar management. These findings suggest that aerobic exercise is not just a healthy habit but also an effective way to manage blood sugar issues. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for non-smoking adults aged 50-80 with type 2 diabetes, particularly those who are sedentary. Women must be postmenopausal for over a year. It's not suitable for individuals with kidney or liver diseases, uncontrolled high blood pressure or cholesterol levels, or a history of cancer, heart disease, or stroke.

Inclusion Criteria

You do not smoke cigarettes.

I am a woman who has been postmenopausal for more than a year.

I am between 50 and 80 years old.

Exclusion Criteria

My blood pressure or cholesterol levels are not well-managed.

I have had cancer in the past.

I have a kidney or liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo aerobic exercise training to assess its efficacy on EPC dysfunction in T2DM

12 weeks

Weekly exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise Training

Trial Overview The study is testing whether aerobic exercise training can improve the function and number of endothelial progenitor cells (EPCs) in older adults with type 2 diabetes. The goal is to see if this leads to better blood vessel health and glucose metabolism.

How Is the Trial Designed?

Group I: T2DM Experimental Treatment 1 Intervention

Type 2 Diabetes Mellitus

Group II: IGT Experimental Treatment 1 Intervention

Impaired Glucose Tolerance

Group III: NGT Active Control 1 Intervention

Normal Glucose Tolerance

Who Is Running the Clinical Trial?

Baltimore VA Medical Center

Lead Sponsor

Trials

33

Recruited

3,000+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0531556525002694

Aerobic exercise training improves blood glucose ... Aerobic exercise training is an effective treatment strategy to improve blood glucose regulation in obese and diabetic populations (Gregory et al., 2019; ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1871609/

The role of physical activity in the management of impaired ... The aim of this systematic review is to establish the effectiveness of physical activity independent of other variables at reducing the risk of diabetes.

3. mdpi.com mdpi.com/2075-1729/15/1/32

Effect of Aerobic Exercise on Blood Glucose Among Those ... Moderate exercise enhances insulin sensitivity, lowers body weight, decreases blood glucose levels, and concurrently improves cardiovascular health.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12278098/

Intervention effect of combined resistance and aerobic ... Combined resistance and aerobic exercise intervention significantly improved fasting blood glucose, LDL-C, HDL-C, TG, and TC levels in patients ...

5. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.107.490391

Treadmill Aerobic Training Improves Glucose Tolerance ... Fifty-eight percent of T-AEX participants with abnormal baseline OGTT (7 of 12) improved glucose tolerance status at 2 hours compared with <10% (1 of 11) of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10015470/

CLINICAL OUTCOMES FOLLOWING EXERCISE ... Evidence has shown that exercise training, inclusive of aerobic and resistance regimens and education, improves outcomes, including exercise capacity, upper and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0168822722008920

Exercise, aerobic fitness, and muscle strength in relation to ... We tested aerobic fitness and isometric strength of five muscle groups after GDM. Muscle strength was strongly associated with changes in glycemic measurements.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11918971/

Aerobic Exercise Improves the Overall Outcome of Type 2 ... Aerobic exercise improves the overall outcome of type 2 diabetes mellitus among people with mental disorders.

9. liebertpub.com liebertpub.com/doi/full/10.1089/dia.2025.8809.dpz

Advances in Exercise and Nutrition as Therapy in Diabetes The diet-plus-exercise intervention was significantly associated with a decreased risk of all-cause death [HR 0.64, 95% CI (0.48–0.84)], CVD ...

10. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07116-3

Effect of resistance vs. aerobic exercise in pre-diabetes: an RCT Aerobic exercise decreases blood glucose levels through weight loss. However, the effect of resistance exercise might not be mediated via weight ...