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Trial · Interventional

RecruitingPhase 4Registry data

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

Short name ZQL008

NCTNCT04575844 (opens ClinicalTrials.gov in a new tab)Other id200065Other idR01DK125330
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
80 participants (estimated)
Sponsor
University of Virginia · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
1 Nov 2020
Primary completion
30 Apr 2027 (estimated)
Completion
30 Apr 2027 (estimated)
First posted
5 Oct 2020
Last update posted
6 May 2026
Conditions
Metabolic Syndrome

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20202022202420262028
  1. Ph 4

    ZQL008

    NCT04575844

    1 Nov 2020 to est. 30 Apr 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • Exercise trainingOther
  • Liraglutide + Exercise trainingDrug

Arms3

  • Experimental

    Exercise Alone

    24 weeks of treatment

  • Experimental

    Liraglutide Alone

    24 weeks of treatment

  • Experimental

    Exercise + Liraglutide

    24 weeks f treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Microvascular Blood Volume - change from baseline

    Time frame · 24 weeks

    Registry description

    measured at baseline and 24 weeks

Secondary outcomes(5)

  1. Augmentation Index - change from baseline

    Time frame · 24 weeks

    Registry description

    measured at baseline and 24 weeks

  2. Flow Mediated Dilation

    Time frame · 24 weeks

    Registry description

    measured at baseline and 24 weeks

  3. Pulse Wave Velocity

    Time frame · 24 weeks

    Registry description

    measured at baseline and 24 weeks

  4. Post Ischemic Flow Velocity - change from baseline

    Time frame · 24weeks

    Registry description

    measured at baseline and 24 weeks

  5. Insulin Sensitivity - change from baseline

    Time frame · 24 weeks

    Registry description

    measured at baseline and 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

8 results

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,535

PMID 27295427PMC4985288DOI 10.1056/nejmoa1603827PUB-27295427

Rights unknown8 results
Source linkSee results (8)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2017

Corrected

3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial.

le Roux et al. 2017Lancet (London, England)cited by 618

PMID 28237263DOI 10.1016/s0140-6736(17)30069-7PUB-28237263

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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