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

Sponsor
University of Virginia (Other)
Overall Status
Recruiting
CT.gov ID
NCT03883412
Collaborator
American Diabetes Association (Other), National Institutes of Health (NIH) (NIH)
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3
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Study Details

Study Description

Brief 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.
Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)
Actual Study Start Date :
Feb 28, 2019
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise Alone

16 weeks of treatment

Other: Exercise
16 weeks of treatment

Experimental: Liraglutide alone

16 weeks of treatment

Drug: Liraglutide
16 weeks of Liraglutide

Experimental: Exercise + Liraglutide

16 weeks of treatment

Other: Exercise
16 weeks of treatment

Drug: Liraglutide
16 weeks of Liraglutide

Outcome Measures

Primary Outcome Measures

  1. Microvascular Blood Volume - change from baseline [16 weeks]

    measured at baseline and 16 weeks

Secondary Outcome Measures

  1. Augmentation Index - change from baseline [16 weeks]

    measured at baseline and 16 weeks

  2. Flow Mediated Dilation - change from baseline [16 weeks]

    measured at baseline and 16 weeks

  3. Pulse Wave Velocity - change from baseline [16 weeks]

    measured at baseline and 16 weeks

  4. Post Ischemic Flow Velocity-Change from baseline [16 weeks]

    measured at baseline and 16 weeks

  5. Insulin Sensitivity-Change from baseline [16 weeks]

    measured at baseline and 16 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Virginia Charlottesville Virginia United States 22906

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Zhenqi Liu, MD, University of Virginia, Department of Endocrinoolgy

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zhenqi Liu, Professor and Chief, Division of Endocrinology and Metabolism, University of Virginia
ClinicalTrials.gov Identifier:
NCT03883412
Other Study ID Numbers:
  • 20320
First Posted:
Mar 20, 2019
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022