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NCT Number: NCT03883412

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

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.

Recruiting

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Key information

Conditions

Type2 Diabetes

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

Our hypothesis is that sustained activation of the GLP-1 receptor with Liraglutide or exercise training will enhance microvascular perfusion, promote angiogenesis, and improve microvascular response to insulin in muscle, leading to increased muscle delivery of oxygen and nutrients and increased exercise tolerance in subjects with type 2 diabetes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Other

16 weeks of treatment

liraglutide

Drug

16 weeks of Liraglutide

Primary outcomes

  1. Microvascular Blood Volume - change from baseline

    Time frame: 16 weeks

    measured at baseline and 16 weeks

Secondary outcomes

  1. Augmentation Index - change from baseline

    Time frame: 16 weeks

    measured at baseline and 16 weeks

  2. Flow Mediated Dilation - change from baseline

    Time frame: 16 weeks

    measured at baseline and 16 weeks

  3. Pulse Wave Velocity - change from baseline

    Time frame: 16 weeks

    measured at baseline and 16 weeks

  4. Post Ischemic Flow Velocity-Change from baseline

    Time frame: 16 weeks

    measured at baseline and 16 weeks

  5. Insulin Sensitivity-Change from baseline

    Time frame: 16 weeks

    measured at baseline and 16 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Lee Hartline, MEd

CONTACT

[email protected]

434-924-5247

Linda Jahn, RN, MEd

CONTACT

[email protected]

434-924-1134

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • American Diabetes Association
  • National Institutes of Health (NIH)

Registry information

Acronym: ZQL007

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2019
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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