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

Primary Purpose

Type2 Diabetes

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exercise
Liraglutide
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Exercise Alone

Liraglutide alone

Exercise + Liraglutide

Arm Description

16 weeks of treatment

16 weeks of treatment

16 weeks of treatment

Outcomes

Primary Outcome Measures

Microvascular Blood Volume - change from baseline
measured at baseline and 16 weeks

Secondary Outcome Measures

Augmentation Index - change from baseline
measured at baseline and 16 weeks
Flow Mediated Dilation - change from baseline
measured at baseline and 16 weeks
Pulse Wave Velocity - change from baseline
measured at baseline and 16 weeks
Post Ischemic Flow Velocity-Change from baseline
measured at baseline and 16 weeks
Insulin Sensitivity-Change from baseline
measured at baseline and 16 weeks

Full Information

First Posted
March 18, 2019
Last Updated
March 7, 2022
Sponsor
University of Virginia
Collaborators
American Diabetes Association, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03883412
Brief Title
Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)
Acronym
ZQL007
Official Title
Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
American Diabetes Association, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Alone
Arm Type
Experimental
Arm Description
16 weeks of treatment
Arm Title
Liraglutide alone
Arm Type
Experimental
Arm Description
16 weeks of treatment
Arm Title
Exercise + Liraglutide
Arm Type
Experimental
Arm Description
16 weeks of treatment
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
16 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
16 weeks of Liraglutide
Primary Outcome Measure Information:
Title
Microvascular Blood Volume - change from baseline
Description
measured at baseline and 16 weeks
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Augmentation Index - change from baseline
Description
measured at baseline and 16 weeks
Time Frame
16 weeks
Title
Flow Mediated Dilation - change from baseline
Description
measured at baseline and 16 weeks
Time Frame
16 weeks
Title
Pulse Wave Velocity - change from baseline
Description
measured at baseline and 16 weeks
Time Frame
16 weeks
Title
Post Ischemic Flow Velocity-Change from baseline
Description
measured at baseline and 16 weeks
Time Frame
16 weeks
Title
Insulin Sensitivity-Change from baseline
Description
measured at baseline and 16 weeks
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Hartline, MEd
Phone
434-924-5247
Email
lmh9d@virginia.eud
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Jahn, RN, MEd
Phone
434-924-1134
Email
las6e@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenqi Liu, MD
Organizational Affiliation
University of Virginia, Department of Endocrinoolgy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenqi Liu, MD
Phone
434-243-2603
Email
zl3e@virginia.edu
First Name & Middle Initial & Last Name & Degree
Eugene Barrett, MD, PhD
Phone
434-924-1175
Email
ejb8x@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)

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