RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-11-01

Study Completion:2025-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04575844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Lee Hartline, MEd

CONTACT

434-924-5247

lmh9d@virginia.edu

Linda Jahn, MEd

CONTACT

434-924-1134

las6e@virginia.edu

Principal Investigator

Zhenqi Liu, MD

PRINCIPAL_INVESTIGATOR

Division of Endocrinology and Metabolism, University of Virginia

Study Locations (Sites)

University of Virginia

Charlottesville, Virginia, 22906

United States

Collaborators and Investigators

Sponsor: University of Virginia

Zhenqi Liu, MD, PRINCIPAL_INVESTIGATOR, Division of Endocrinology and Metabolism, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-01

Study Completion Date2025-04-01

Study Record Updates

Study Start Date2020-11-01

Study Completion Date2025-04-01

Terms related to this study

Additional Relevant MeSH Terms

Metabolic Syndrome