Effects of Empagliflozin on Cardiac Microvasculature and Insulin Sensitivity in Subjects With Type 2 Diabetes

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT04203927
Phase
EARLY_PHASE1
Status
Unknown

Conditions

  • Insulin Sensitivity
  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The aim is to test in T2DM patients, whether, compared to placebo, 12 weeks of SGLT-2 inhibitor improves post-absorptive, post-insulin infusion or postprandial insulin action to enhance Cardiac Muscle vascular function and whether changes correlate with improved GV or postprandial hyperglycemia

Key Dates

Start date
Feb 1, 2020
Status verified
Feb 2022
Primary completion
Oct 30, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Empagliflozin + insulin infusion
    vascular measurements in overnight fasted state and during insulin infusion
  • Active Comparator: Empagliflozin + mixed meal
    vascular measurements in overnight fasted state and 2 hours after mixed meal 10kcal/kg body weight ( 55% Cho, 30%Fat, 20% Pro)

Primary Outcome Measure

Myocardial microvascular perfusion [ Time Frame: Between baseline and 12 weeks treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22906
Eugene Barrett, MD, PhD
[email protected]
434-924-1175
Zhenqi Liu, MD
[email protected]

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By research site
University of Virginia· Charlottesville, VA

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