Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)
NCT ID: NCT03883412
Last Updated: 2023-12-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-02-28
Study Completion Date
2025-12-31
Brief Summary
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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
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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.
Conditions
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Type2 Diabetes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Exercise Alone
16 weeks of treatment
Group Type
EXPERIMENTAL
Exercise
Intervention Type
OTHER
16 weeks of treatment
Liraglutide alone
16 weeks of treatment
Group Type
EXPERIMENTAL
Liraglutide
Intervention Type
DRUG
16 weeks of Liraglutide
Exercise + Liraglutide
16 weeks of treatment
Group Type
EXPERIMENTAL
Exercise
Intervention Type
OTHER
16 weeks of treatment
Liraglutide
Intervention Type
DRUG
16 weeks of Liraglutide
Interventions
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Exercise
16 weeks of treatment
Intervention Type
OTHER
Liraglutide
16 weeks of Liraglutide
Intervention Type
DRUG
Eligibility Criteria
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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
* 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)
* 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)
Minimum Eligible Age
21 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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American Diabetes Association
OTHER
Sponsor Role
collaborator
National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
University of Virginia
OTHER
Sponsor Role
lead
Responsible Party
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Zhenqi Liu
Professor and Chief, Division of Endocrinology and Metabolism
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Zhenqi Liu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia, Department of Endocrinoolgy
Locations
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University of Virginia
Charlottesville, Virginia, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Zhenqi Liu, MD
Role: primary
Eugene Barrett, MD, PhD
Role: backup
References
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Other Identifiers
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20320
Identifier Type: -
Identifier Source: org_study_id