60 Participants Needed

Exercise for Type 2 Diabetes

Recruiting at 2 trial locations
EM
SK
Overseen BySteven K Malin, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
Must be taking: Metformin, GLP-1 agonists
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 does not specify if you need to stop taking your current medications, but it excludes participants who are taking certain medications like vasoactive drugs. If you're on medications like metformin or GLP-1 agonists, you must have been on them for at least a year to participate.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for Type 2 Diabetes?

Research shows that regular exercise can significantly improve blood sugar control, reduce the risk of heart problems, and enhance overall health in people with Type 2 diabetes. Exercise is as effective as some medications in managing diabetes, and combining aerobic and resistance exercises can maximize these benefits.12345

Is exercise safe for people with type 2 diabetes?

Exercise is generally safe for people with type 2 diabetes if certain precautions are taken, such as monitoring glucose levels and considering individual health conditions like diabetic foot or cardiovascular risks. It's important to adapt exercise routines to each person's needs and consult healthcare providers to minimize the risk of injury or adverse events.678910

How does exercise as a treatment for type 2 diabetes differ from other treatments?

Exercise is unique for type 2 diabetes because it is a non-drug treatment that improves insulin sensitivity and glycemic control, reduces body fat, and enhances cardiovascular fitness. Unlike medications, exercise requires regular physical activity to maintain its benefits and can be tailored to individual needs, making it a flexible and cost-effective option.911121314

What is the purpose of this trial?

Extracellular vesicles (EVs) play a role in obesity-induced insulin resistance and likely impact the development of cardiovascular disease. However, little is known on how EVs affect vascular insulin action in people. The purpose of this study is to understand how EVs play a role in type 2 diabetes related cardiovascular disease. This research will also study if exercise can change how EVs impact blood flow and metabolic health. This study will contribute to designing precision medicine to treat/prevent cardiovascular disease in type 2 diabetes.

Research Team

SK

Steven K Malin, PhD

Principal Investigator

Rutgers University - New Brunswick

Eligibility Criteria

This trial is for individuals with Type 2 Diabetes and obesity, aiming to understand how extracellular vesicles (EVs) affect cardiovascular disease related to diabetes. Participants should be interested in how exercise might influence their blood flow and metabolic health.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes or my tests show high blood sugar.
Not currently engaged in >90 min/wk of exercise
I am between 40 and 70 years old.
See 4 more

Exclusion Criteria

I have been prescribed diabetes medication in the past year.
Intolerance to insulin
I have type 1 diabetes and need insulin.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo supervised exercise training sessions at 85% VO2max, expending approximately 400 kcal per session

16 weeks
3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Exercise
Trial Overview The study focuses on the role of EVs in vascular insulin action and examines whether regular exercise can modify the effects of EVs on metabolism and cardiovascular health in people with Type 2 Diabetes.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Obesity with Type 2 DiabetesExperimental Treatment1 Intervention
Participants with obesity and type 2 diabetes will participate in 3 supervised exercise training sessions at 85% VO2max that expends \~400 kcal for 16 weeks.
Group II: Obesity with Normal Glucose ToleranceExperimental Treatment1 Intervention
Participants with obesity and normal glucose tolerance will participate in 3 supervised exercise training sessions at 85% VO2max that expends \~400 kcal for 16 weeks.
Group III: Lean with Normal Glucose ToleranceActive Control1 Intervention
Participants will not receive the study intervention and will be healthy controls.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

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

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.
Revisiting the role of physical activity and exercise in the treatment of type 2 diabetes.Tudor-Locke, CE., Bell, RC., Meyers, AM.[2019]
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.
Exercise therapy in type 2 diabetes.Praet, SF., van Loon, LJ.[2021]
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.
Exercise prescription and the patient with type 2 diabetes: a clinical approach to optimizing patient outcomes.Waryasz, GR., McDermott, AY.[2010]

References

Revisiting the role of physical activity and exercise in the treatment of type 2 diabetes. [2019]
Exercise therapy in type 2 diabetes. [2021]
Exercise prescription and the patient with type 2 diabetes: a clinical approach to optimizing patient outcomes. [2010]
Physical activity and type 2 diabetes. Recommandations of the SFD (Francophone Diabetes Society) diabetes and physical activity working group. [2013]
The Role of Individualized Exercise Prescription in Type 2 Diabetes Mellitus Management. [2022]
Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. [2013]
Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]
Resources to Guide Exercise Specialists Managing Adults with Diabetes. [2020]
Diet and exercise in type 2 diabetes mellitus. [2019]
[Exercise prescription for diabetics: more than a general recommendation]. [2008]
11.United Statespubmed.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]
[Individualized exercise training prescription for patients with type 2 diabetes mellitus]. [2011]
[Physical activity as a therapeutic tool in type 2 diabetes: the rationale]. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
American College of Sports Medicine position stand. Exercise and type 2 diabetes. [2022]
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