150 Participants Needed

Cardiovascular Exercise for Type 2 Diabetes

(REACH Trial)

Recruiting at 1 trial location
DR
BJ
Overseen ByBenjamin Juckett, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Cardiovascular Exercise for Type 2 Diabetes?

Research shows that aerobic exercise can improve blood sugar control and reduce heart disease risk factors in people with type 2 diabetes. Exercise, including both aerobic and resistance training, is effective in managing diabetes and heart health, often comparable to medication.12345

Is cardiovascular exercise safe for people with type 2 diabetes?

Cardiovascular exercise is generally safe for people with type 2 diabetes if certain precautions are taken, such as adapting the exercise to individual health conditions and monitoring for potential complications like diabetic foot or cardiovascular issues.16789

How does cardiovascular exercise differ from other treatments for type 2 diabetes?

Cardiovascular exercise is unique because it is a non-drug treatment that improves insulin sensitivity and reduces cardiovascular risk factors, such as high blood pressure and cholesterol, through regular physical activity. Unlike medications, it also helps with weight management and overall fitness, making it a holistic approach to managing type 2 diabetes.1791011

What is the purpose of this trial?

The goal of this two-site grant proposal is to determine the role of the decreased insulin-mediated muscle perfusion found in type 2 diabetes in contributing to the development of cardiac and skeletal muscle dysfunction and subsequent functional exercise impairment. In addition, it is also our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance.

Eligibility Criteria

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.
See 11 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Type 2 DiabetesExperimental Treatment1 Intervention
Participants aged 30-55 with type 2 diabetes
Group II: Healthy overweight controlExperimental Treatment1 Intervention
Participants aged 30-55 with BMI 25-40 without type 2 diabetes

Find a Clinic Near You

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+

Findings from Research

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.
The Effects of Chronic Aerobic Exercise on Cardiovascular Risk Factors in Persons with Diabetes Mellitus.Miele, EM., Headley, SAE.[2018]
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.
[Aerobic and strength training in patients with diabetes mellitus type 2 and heart failure].Niederseer, D., Niebauer, J.[2021]
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.
Exercise for prevention and treatment of cardiovascular disease, type 2 diabetes, and metabolic syndrome.Gaesser, GA.[2022]

References

The Effects of Chronic Aerobic Exercise on Cardiovascular Risk Factors in Persons with Diabetes Mellitus. [2018]
[Aerobic and strength training in patients with diabetes mellitus type 2 and heart failure]. [2021]
Exercise for prevention and treatment of cardiovascular disease, type 2 diabetes, and metabolic syndrome. [2022]
The effects of three different low-volume aerobic training protocols on cardiometabolic parameters of type 2 diabetes patients: A randomized clinical trial. [2023]
Revisiting the role of physical activity and exercise in the treatment of type 2 diabetes. [2019]
Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. [2013]
Re-evaluation of exercise prescription for Japanese type 2 diabetic patients by ventilatory threshold. [2022]
Evaluation of Aerobic Exercise Intensity in Patients with Coronary Artery Disease and Type 2 Diabetes Mellitus. [2020]
May the force be with you: why resistance training is essential for subjects with type 2 diabetes mellitus without complications. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Cardiovascular fitness and type 2 diabetes. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Exercise training and the cardiovascular consequences of type 2 diabetes and hypertension: plausible mechanisms for improving cardiovascular health. [2022]
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