DRUG
Liraglutide
24 weeks of Liraglutide
Status
Recruiting
Phase
Phase 4
Enrollment
80
Locations
1
Results
Not posted
Publications
12
Study 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.
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
DRUG
24 weeks of Liraglutide
OTHER
24 weeks of Exercise training
DRUG
24 weeks of Liraglutide + Exercise training
Timeline
First posted
Oct 5, 2020
Study start
Nov 1, 2020
Primary completion
Apr 30, 2027
Study completion
Apr 30, 2027
Results posted
Not reported
Registry updated
May 6, 2026
Outcomes
Microvascular Blood Volume - change from baseline
Time frame · 24 weeks
measured at baseline and 24 weeks
Augmentation Index - change from baseline
Time frame · 24 weeks
measured at baseline and 24 weeks
Flow Mediated Dilation
Time frame · 24 weeks
measured at baseline and 24 weeks
Pulse Wave Velocity
Time frame · 24 weeks
measured at baseline and 24 weeks
Post Ischemic Flow Velocity - change from baseline
Time frame · 24weeks
measured at baseline and 24 weeks
Insulin Sensitivity - change from baseline
Time frame · 24 weeks
measured at baseline and 24 weeks
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Virginia
Charlottesville, Virginia, United States
Publications
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