Exercise rehabilitation in peripheral artery disease: functional impact and mechanisms of benefits.
Naomi M Hamburg, Gary J Balady
https://pubmed.ncbi.nlm.nih.gov/21200015/Actively Recruiting
Led by University of Virginia · Updated on 2026-08-12
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are investigating how exercise training, liraglutide treatment, or a combination of both affect blood flow in small vessels, large blood vessel function, and insulin action in adults with Type 2 diabetes. The study aims to see if activating the GLP-1 receptor with liraglutide or exercising can improve muscle blood flow, promote new blood vessel growth, and enhance insulin response, potentially leading to better oxygen and nutrient delivery and higher exercise tolerance. Participants will be randomly assigned to one of three groups exercise training alone, liraglutide treatment alone, or both exercise training plus liraglutide. Each group will undergo 16 weeks of their assigned intervention. The treatments involve sustained activation of the GLP-1 receptor or exercise training to evaluate their effects on vascular and metabolic function. During the study, participants will be assessed at the start and after 16 weeks of intervention. Researchers will measure changes in microvascular blood volume as the primary outcome. Secondary outcomes include various measures of blood vessel function and insulin sensitivity. The study includes monitoring vascular health and metabolic responses to understand the benefits of the interventions in adults aged 21 to 60 with Type 2 diabetes.
CONDITIONS
Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)
L
Lee Hartline, MEd
L
Linda Jahn, RN, MEd
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University of Virginia
Lead Sponsor
American Diabetes Association
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Exercise Alone | Liraglutide Alone | Exercise + Liraglutide |
|---|---|---|---|
| What it is | A supervised exercise program over 16 weeks added to usual diabetes medication. | Liraglutide therapy for 16 weeks, added to stable oral hypoglycemic agents for type 2 diabetes. | Combination of supervised exercise with liraglutide, both for 16 weeks alongside existing background diabetes medication. |
| Role in trial | Used to test whether exercise improves microvascular function and insulin sensitivity over standard medication. | Evaluates the effect of liraglutide on vascular and metabolic outcomes compared to background medication. | Tests whether combining exercise with liraglutide has additional effects on vascular function and insulin sensitivity. |
| Primary use | Improving microvascular blood volume and insulin sensitivity by supervised exercise in adults with type 2 diabetes. | Testing liraglutide’s effects on vascular function and metabolic control in people with type 2 diabetes. | Evaluating whether combining exercise with liraglutide provides additive improvement in vascular function and insulin sensitivity. |
| How it is given or performed | Participants attend supervised exercise sessions as part of the intervention for 16 weeks. | Liraglutide is administered for 16 weeks, with no exercise intervention. | Both supervised exercise and liraglutide are delivered together throughout the 16-week study period. |
| Evidence status | Robust external evidence supports that exercise increases skeletal muscle capillarization and improves insulin sensitivity among adults with type 2 diabetes. | Published preclinical evidence shows glucagon-like peptide-1 agonists like liraglutide directly enhance myocardial contractility and glucose uptake; larger human studies have demonstrated improved glycemic control. | Combined exercise and liraglutide therapy is under trial investigation to determine potential additive effects. No direct published results yet for this regimen in adults with type 2 diabetes. |
| Important limitations | The effect of exercise can be impacted by participant adherence and supervised session quality. Not all patients are able or willing to participate in structured exercise programs. | Long-term effects of liraglutide on microvascular outcomes are still being studied. Common limitations include GLP-1RA ineligibility due to prior exposure, contraindications, or intolerance. | Combined therapy’s benefits and risks have not been established; the factorial trial aims to clarify these outcomes. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 16 weeks
Participants receive either exercise training, liraglutide injections, or both for 16 weeks as assigned.
Regular visits during the 16 weeks
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/3301899/University of Virginia
Lead Sponsor
American Diabetes Association
Collaborating Sponsor