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

Last updated: December 19, 2023
Sponsor: University of Virginia
Overall Status: Active - Recruiting

Phase

4

Condition

Stress

Hormone Deficiencies

Hypertriglyceridemia

Treatment

Liraglutide

Exercise

Clinical Study ID

NCT03883412
20320
  • Ages 21-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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.

Eligibility Criteria

Inclusion

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

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 vasculardisease
  • Presence of an intracardiac or intrapulmonary shunt (we will screen for this byauscultation during the physical exam by PI).
  • Pregnant or breastfeeding.
  • Known hypersensitivity to perflutren (contained in Definity)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Liraglutide
Phase: 4
Study Start date:
February 28, 2019
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • University of Virginia

    Charlottesville, Virginia 22906
    United States

    Active - Recruiting

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