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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-60
SponsorUniversity of Virginia

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Taking Insulin

Smoking presently or in the past 6 months

BP >160/90

BMI >35

Trial design

Design model

Factorial

Treatments tested in this trial

  • Exercise

    Other intervention

    16 weeks of treatment

  • Liraglutide

    Drug

    16 weeks of Liraglutide

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Exercise AloneExperimental treatment 1 intervention
Group B: Liraglutide aloneExperimental treatment 1 intervention
Group C: Exercise + LiraglutideExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Microvascular Blood Volume - change from baseline

measured at baseline and 16 weeks

Time frame
16 weeks

Secondary outcomes

1

Augmentation Index - change from baseline

measured at baseline and 16 weeks

Time frame
16 weeks
2

Flow Mediated Dilation - change from baseline

measured at baseline and 16 weeks

Time frame
16 weeks
3

Pulse Wave Velocity - change from baseline

measured at baseline and 16 weeks

Time frame
16 weeks
4

Post Ischemic Flow Velocity-Change from baseline

measured at baseline and 16 weeks

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

American Diabetes Association

Collaborator

National Institutes of Health (NIH)

Collaborator