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

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The discovery of the role of endothelial progenitor cells (EPCs) and their involvement in the cardiovascular complications of type 2 diabetes (T2DM) would quickly have a significant impact on the millions of Americans who have T2DM. This project is designed to 1) determine the mechanisms underlying EPC dysfunction in older, sedentary adults with T2DM compared those with normal glucose metabolism and impaired glucose metabolism, and 2) determine if aerobic exercise training is an efficacious therapy for EPC dysfunction in T2DM, and whether improvement in EPC number and function translates to improved endothelial function, increased capillarization, and improved glucose metabolism in T2DM.

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.

Is aerobic exercise generally safe for humans?

Aerobic exercise is generally considered safe for humans, including those with type 2 diabetes, as it can improve heart health and help control blood sugar levels. It is recommended as part of diabetes care guidelines and has been shown to be safe and beneficial when not limited by other health conditions. ^{1 2 3 4 5}

How is aerobic exercise training unique as a treatment for type 2 diabetes?

Aerobic exercise training is unique because it focuses on improving insulin resistance and cardiovascular health through activities like walking, cycling, and swimming, which enhance the insulin-signaling pathway. Unlike some other treatments, it can be combined with resistance training to further increase muscle strength and improve quality of life. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Aerobic Exercise Training for Type 2 Diabetes?

Research shows that aerobic exercise improves blood sugar control and overall health in people with type 2 diabetes. Studies found that combining aerobic exercise with resistance training is even more effective than doing either type alone. ^{9 10 11 12 13}

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

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]

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]

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. Germany pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise, resistance exercise or both, on patient-reported health status and well-being in type 2 diabetes mellitus: a randomised trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of aerobic physical exercise in the elderly with type 2 diabetes mellitus. [2019]

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

Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Aerobic and resistance training effects compared to aerobic training alone in obese type 2 diabetic patients on diet treatment. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Aerobic Training Variables Progression on Glycemic Control of Patients with Type 2 Diabetes: a Systematic Review with Meta-analysis. [2023]

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

The Effects of Chronic Aerobic Exercise on Cardiovascular Risk Factors in Persons with Diabetes Mellitus. [2018]

7. United States 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. [2019]

8. Japan pubmed.ncbi.nlm.nih.gov

[Exercise therapy for the aged diabetics]. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Aerobic Exercise Intensity in Patients with Coronary Artery Disease and Type 2 Diabetes Mellitus. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of interventions that include diet, aerobic and resistance training components for type 2 diabetes prevention: a systematic review with meta-analysis. [2022]

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

Moving beyond cardio: the value of resistance training, balance training, and other forms of exercise in the management of diabetes. [2020]

12. China pubmed.ncbi.nlm.nih.gov

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

13. Ireland pubmed.ncbi.nlm.nih.gov

Re-evaluation of exercise prescription for Japanese type 2 diabetic patients by ventilatory threshold. [2022]