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

NCT ID: NCT04575844

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise Alone

24 weeks of treatment

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

24 weeks of Exercise training

Liraglutide Alone

24 weeks of treatment

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

24 weeks of Liraglutide

Exercise + Liraglutide

24 weeks f treatment

Group Type EXPERIMENTAL

Liraglutide + Exercise training

Intervention Type DRUG

24 weeks of Liraglutide + Exercise training

Interventions

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Liraglutide

24 weeks of Liraglutide

Intervention Type DRUG

Exercise training

24 weeks of Exercise training

Intervention Type OTHER

Liraglutide + Exercise training

24 weeks of Liraglutide + Exercise training

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Zhenqi Liu

Professor, Division of Endocrinology and Metabolism

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhenqi Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology and Metabolism, University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lee Hartline, MEd

Role: CONTACT

434-924-5247

Linda Jahn, MEd

Role: CONTACT

434-924-1134

Facility Contacts

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Zhenqi Liu, MD

Role: primary

434-243-2603

Eugene Barrett, MD, PhD

Role: backup

434-924-1175

References

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Other Identifiers

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R01DK125330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

200065

Identifier Type: -

Identifier Source: org_study_id

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