ZQL008

RecruitingPhase 4

Effects of Exercise and GLP-1 Agonism on Muscle Microvascular Perfusion and Insulin Action in Adults With Metabolic Syndrome

Lead sponsor

University of Virginia

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Metabolic syndrome, Obesity / overweight

Key I/E criterion

•BMI 25-35

Primary endpoint

•Microvascular Blood Volume - change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04575844

Secondary IDR01DK125330

Timeline

Milestones

Study first posted2020-10-05actual

Study start2020-11-01actual

Last update posted2026-05-06actual

Primary completion2027-04-30estimated

Study completion2027-04-30estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Metabolic syndromeObesity / overweight

Eligibility

Who can enroll

Minimum age21 Years

Maximum age60 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Insulin Sensitivity - change from baseline

Time frame:24 weeks

HOMA-IR (insulin sensitivity)