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)

Enrollment

Location

Arms

57.1

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

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
Type2 Diabetes	Other: Exercise Drug: Liraglutide	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

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

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

Secondary Outcome Measures

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

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Insulin Resistance

Liraglutide

Study Results

No Results Posted as of Mar 8, 2022