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

Type2 Diabetes Clinical Trial

— ZQL007  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03883412
• Other study ID #: 20320
• Status: Recruiting
• Phase: Phase 4
• Start date: February 28, 2019
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: University of Virginia
• Contact: Lee Hartline, MEd
• Phone: 434-924-5247
• Email: lmh9d[@]virginia.eud
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type2 Diabetes

Intervention

Other:
• Exercise
16 weeks of treatment

Drug:
• Liraglutide
16 weeks of Liraglutide

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	American Diabetes Association, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular Blood Volume - change from baseline	measured at baseline and 16 weeks	16 weeks
Secondary	Augmentation Index - change from baseline	measured at baseline and 16 weeks	16 weeks
Secondary	Flow Mediated Dilation - change from baseline	measured at baseline and 16 weeks	16 weeks
Secondary	Pulse Wave Velocity - change from baseline	measured at baseline and 16 weeks	16 weeks
Secondary	Post Ischemic Flow Velocity-Change from baseline	measured at baseline and 16 weeks	16 weeks
Secondary	Insulin Sensitivity-Change from baseline	measured at baseline and 16 weeks	16 weeks