Examining the effects of exercise and liraglutide on blood vessel function in Type 2 diabetes
Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)
PHASE4 · University of Virginia · NCT03883412
This study is testing whether exercise, a diabetes medication called liraglutide, or a mix of both can improve blood flow and how well the body uses insulin in people with Type 2 diabetes.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | University of Virginia (other) |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT03883412 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of exercise training, liraglutide treatment, or a combination of both on vascular function and insulin sensitivity in individuals with Type 2 diabetes. Participants will be randomly assigned to one of three groups: exercise only, liraglutide only, or both interventions. The study aims to determine if these treatments can enhance blood flow and improve metabolic responses in muscle over a 16-week period. The primary outcomes include changes in cardiac and muscle capillary blood volume and overall vascular function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-60 with Type 2 diabetes who have not previously used GLP-1 receptor agonists or DPP-4 inhibitors.
Not a fit: Patients currently taking insulin or with significant cardiovascular or metabolic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for enhancing vascular health and insulin sensitivity in patients with Type 2 diabetes.
How similar studies have performed: Previous studies have shown promising results with exercise and GLP-1 receptor agonists in improving metabolic health, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 21-60 * A1C ≤ 8.5% * Never on GLP-1RA (eg: exenatide, liraglutide) or DPP4I ( eg: Sitaglipton) * On stable dose of oral hypoglycemic agents \>4 months * On stable dose of other medications for \>4 months Exclusion Criteria: * Taking Insulin * Smoking presently or in the past 6 months * BP \>160/90 * BMI \>35 * Family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome * History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease. * Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease * Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI). * Pregnant or breastfeeding. * Known hypersensitivity to perflutren (contained in Definity)
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Zhenqi Liu, MD — University of Virginia, Department of Endocrinoolgy
- Study coordinator: Lee Hartline, MEd
- Email: lmh9d@virginia.eud
- Phone: 434-924-5247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type2 Diabetes