Type2 Diabetes
Conditions
Brief summary
The primary objective of this study is to examine whether exercise training alone, liraglutide treatment alone or exercise training plus liraglutide treatment increases cardiac and muscle capillary blood volume, improves vascular function in the larger conduit vessels, and enhances insulin's metabolic action in humans with Type 2 diabetes. Subjects will be randomized to one of the three groups: exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 16 weeks of intervention.
Detailed description
Our hypothesis is that sustained activation of the GLP-1 receptor with Liraglutide or exercise training will enhance microvascular perfusion, promote angiogenesis, and improve microvascular response to insulin in muscle, leading to increased muscle delivery of oxygen and nutrients and increased exercise tolerance in subjects with type 2 diabetes.
Interventions
OTHERExercise
16 weeks of treatment
DRUGLiraglutide
16 weeks of Liraglutide
Sponsors
University of Virginia
American Diabetes Association
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microvascular Blood Volume - change from baseline | 16 weeks | measured at baseline and 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Augmentation Index - change from baseline | 16 weeks | measured at baseline and 16 weeks |
| Flow Mediated Dilation - change from baseline | 16 weeks | measured at baseline and 16 weeks |
| Pulse Wave Velocity - change from baseline | 16 weeks | measured at baseline and 16 weeks |
| Post Ischemic Flow Velocity-Change from baseline | 16 weeks | measured at baseline and 16 weeks |
| Insulin Sensitivity-Change from baseline | 16 weeks | measured at baseline and 16 weeks |
Countries
United States
Contacts
CONTACTLee Hartline, MEd
CONTACTLinda Jahn, RN, MEd
PRINCIPAL_INVESTIGATORZhenqi Liu, MD
University of Virginia, Department of Endocrinoolgy
Outcome results
None listed