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

Phase 4

Recruiting

• Conditions: Type2 Diabetes
• Interventions: Other: Exercise; Drug: Liraglutide

• Registration Number: NCT03883412
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study Start: 2019-02-28
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Exercise + Liraglutide	Liraglutide	16 weeks of treatment
Exercise + Liraglutide	Exercise	16 weeks of treatment
Liraglutide alone	Liraglutide	16 weeks of treatment
Exercise Alone	Exercise	16 weeks of treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Insulin Sensitivity-Change from baseline	16 weeks	measured at baseline and 16 weeks
Augmentation Index - 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

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States