Metabolic Syndrome
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 skeletal muscle microvascular blood volume, improves vascular function of the conduit vessels, and enhances insulin's metabolic action in humans with Metabolic Syndrome. Subjects will be randomized to one of the 4 groups: control, exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 24 weeks of intervention.
Detailed description
Our hypothesis is that sustained activation of the GLP-1 receptor with Liraglutide and exercise training each will enhance microvascular insulin responses and angiogenesis in both cardiac and skeletal muscle to increase muscle insulin delivery and action and the combination of both is more effective than either alone in adults with metabolic syndrome.
Interventions
DRUGLiraglutide
24 weeks of Liraglutide
OTHERExercise training
24 weeks of Exercise training
DRUGLiraglutide + Exercise training
24 weeks of Liraglutide + Exercise training
Sponsors
University of Virginia
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
* Male or female ≥21 and ≤60 years old. * Body mass index \>25 and ≤35 kg/m2 and is weight stable (\<5 kg weight change in the past 6 months). BMI is limited to ≤35 kg/m2 for easier vascular access and cardiac imaging. * Meet 3 of 5 National Cholesterol Education Program Adult Treatment Panel III Metabolic Syndrome criteria: * Increased waist circumference (≥102 cm in men; ≥88 cm in women) * Elevated triglycerides (≥150 mg/dl) * Reduced HDL-cholesterol (\<40mg/dl in men, \<50 mg/dl in women) * High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic) * Elevated fasting glucose (≥100 mg/dl) * Subject may participate if on the following drugs, provided the drug doses have been stable for at least 3 months. * Ace inhibitor * ARB * HMG CoA reductase inhibitor * Beta blocker * Calcium channel blockers * Alpha-adrenergic antagonist * Statin
Exclusion criteria
* A diagnosis of any type of diabetes or history of diabetes medication use * Recently active (\>20 min of moderate/high intensity exercise, 2 times/week) * Subjects who are smokers or who have quit smoking \<5 years * Subjects with hypertriglyceridemia (\>400 mg/dl) or hypercholesterolemia (\>260 mg/dl) * Subjects with BP\>160/90 * Subjects with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or malignancy * Pregnant (as evidenced by positive pregnancy test) or nursing women * Subjects with contraindications to participation in an exercise training program * Allergic to perflutren * A prior use of Liraglutide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microvascular Blood Volume - change from baseline | 24 weeks | measured at baseline and 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Augmentation Index - change from baseline | 24 weeks | measured at baseline and 24 weeks |
| Flow Mediated Dilation | 24 weeks | measured at baseline and 24 weeks |
| Pulse Wave Velocity | 24 weeks | measured at baseline and 24 weeks |
| Post Ischemic Flow Velocity - change from baseline | 24weeks | measured at baseline and 24 weeks |
| Insulin Sensitivity - change from baseline | 24 weeks | measured at baseline and 24 weeks |
Countries
United States
Contacts
CONTACTLee Hartline, MEd
CONTACTLinda Jahn, MEd
PRINCIPAL_INVESTIGATORZhenqi Liu, MD
Division of Endocrinology and Metabolism, University of Virginia
Outcome results
None listed