Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)

Short name ZQL007

NCTNCT03883412Other id20320

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 60 participants (estimated)
Sponsor: University of Virginia · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 28 Feb 2019
Primary completion: Jun 2027 (estimated)
Completion: Dec 2027 (estimated)
First posted: 20 Mar 2019
Last update posted: 12 Aug 2026
Conditions: Type2 Diabetes

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20202022202420262028

Ph 4
ZQL007
NCT03883412
28 Feb 2019 to est. Dec 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 muscle capillary blood volume, improves vascular function in the larger conduit vessels, and enhances insulin's metabolic action in humans with Type 2 diabetes. Subjects will be randomized to one of the three groups: exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 16 weeks of intervention.

Interventions

ExerciseOther
LiraglutideDrug

Arms3

Experimental
Exercise Alone
16 weeks of treatment
Experimental
Liraglutide alone
16 weeks of treatment
Experimental
Exercise + Liraglutide
16 weeks of treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

Microvascular Blood Volume - change from baseline
Time frame · 16 weeks
Registry description
measured at baseline and 16 weeks

Secondary outcomes(5)

Augmentation Index - change from baseline
Time frame · 16 weeks
Registry description
measured at baseline and 16 weeks
Flow Mediated Dilation - change from baseline
Time frame · 16 weeks
Registry description
measured at baseline and 16 weeks
Pulse Wave Velocity - change from baseline
Time frame · 16 weeks
Registry description
measured at baseline and 16 weeks
Post Ischemic Flow Velocity-Change from baseline
Time frame · 16 weeks
Registry description
measured at baseline and 16 weeks
Insulin Sensitivity-Change from baseline
Time frame · 16 weeks
Registry description
measured at baseline and 16 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

Studies0

Studies that cite this trial.

No study cites this trial.

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: * Age 21-60 * A1C ≤ 8.5% * Never on GLP-1RA (eg: exenatide, liraglutide) or DPP4I ( eg: Sitaglipton) * On stable dose of oral hypoglycemic agents \>4 months * On stable dose of other medications for \>4 months Exclusion Criteria: * Taking Insulin * Smoking presently or in the past 6 months * BP \>160/90 * BMI \>35 * Family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome * History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease. * Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease * Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI). * Pregnant or breastfeeding. * Known hypersensitivity to perflutren (contained in Definity)

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