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

NCT04575844 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 200065R01DK125330
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Microvascular Blood Volume - change from baseline

  measured at baseline and 24 weeks

  24 weeks

Secondary Outcomes (5)

• Augmentation Index - change from baseline

  24 weeks

• Flow Mediated Dilation

  24 weeks

• Pulse Wave Velocity

  24 weeks

• Post Ischemic Flow Velocity - change from baseline

  24weeks

• Insulin Sensitivity - change from baseline

  24 weeks

Study Arms (3)

Exercise Alone

EXPERIMENTAL

24 weeks of treatment

Other: Exercise training

Liraglutide Alone

EXPERIMENTAL

24 weeks of treatment

Drug: Liraglutide

Exercise + Liraglutide

EXPERIMENTAL

24 weeks f treatment

Drug: Liraglutide + Exercise training

Interventions

Liraglutide DRUG

24 weeks of Liraglutide

Liraglutide Alone

Exercise training OTHER

24 weeks of Exercise training

Exercise Alone

Liraglutide + Exercise training DRUG

24 weeks of Liraglutide + Exercise training

Exercise + Liraglutide

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22906, United States

RECRUITING

Related Publications (38)

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MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Liraglutide; Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zhenqi Liu, MD

  Division of Endocrinology and Metabolism, University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Hartline, MEd

CONTACT

434-924-5247; lmh9d@virginia.edu

Linda Jahn, MEd

CONTACT

434-924-1134; las6e@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Endocrinology and Metabolism

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 5, 2020
• Study Start: November 1, 2020
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)