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

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Empagliflozin; Insulin

Criteria

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.