Recruiting
Early Phase 1

Empagliflozin

Sponsor:

University of Virginia

Code:

NCT04203927

Conditions

Type2 Diabetes

Insulin Sensitivity

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 25 MG

Study Details

Brief summary:

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

Conditions

Type2 Diabetes

Insulin Sensitivity

Study ID

NCT04203927

Start date

Feb 1, 2020

Status verified date

Feb, 2022

Completion date

Nov 30, 2023

Anticipated

Primary completion date

Oct 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A1C > 6.5 and <9%
  • Never on SGLT-2i (eg: Jardiance, Invokana, Farxiga, Steglatro)
  • On stable dose of oral hypoglycemic agents >3 months
  • On stable dose of other medications for >3 months
  • BMI-<35

Exclusion Criteria:

  • • Smoking presently or in the past 6 months

  • Taking insulin
  • BP >160/90
  • BMI >35
  • 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
  • History of cancer or psychiatric 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)
  • Screening O2 saturation <90%
  • History of recurrent UTI/bladder/kidney infections-eGFR is below 45 mL/min/1.73.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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)

Interventions

Empagliflozin 25 MG

SGLT-2 inhibitor

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Eugene J Barrett, MD PhD

434-924-1263ejb8x@virginia.edu

Lee Hartline, MEd

434-924-5247lmh9d@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22906

Contacts

Eugene Barrett, MD, PhD

434-924-1175ejb8x@virginia.edu

Zhenqi Liu, MD

zl3e@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Feb 10, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2022-02-10.