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

December 19, 2023 updated by: Zhenqi Liu, University of Virginia
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22906
        • Recruiting
        • University of Virginia
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microvascular Blood Volume - change from baseline
Time Frame: 16 weeks
measured at baseline and 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Augmentation Index - change from baseline
Time Frame: 16 weeks
measured at baseline and 16 weeks
16 weeks
Flow Mediated Dilation - change from baseline
Time Frame: 16 weeks
measured at baseline and 16 weeks
16 weeks
Pulse Wave Velocity - change from baseline
Time Frame: 16 weeks
measured at baseline and 16 weeks
16 weeks
Post Ischemic Flow Velocity-Change from baseline
Time Frame: 16 weeks
measured at baseline and 16 weeks
16 weeks
Insulin Sensitivity-Change from baseline
Time Frame: 16 weeks
measured at baseline and 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institutes of Health (NIH)
American Diabetes Association

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2019

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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