Effects of Empagliflozin on Cardiac Microvasculature and Insulin Sensitivity in Subjects With Type 2 Diabetes (EJB051)

February 9, 2022 updated by: Eugene Barrett, University of Virginia
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will study 32 T2DM subjects measuring cardiac muscle vascular function before and after a 4 hour insulin clamp ( protocol A) and before and after a mixed meal (protocol B). Then subjects will be randomized into 2 groups: Group 1 will undergo a 12 week intervention of Empagliflozin, and Group 2 will do 12 weeks of Placebo. The intervention will be single blinded. At the end of the 12 week intervention subjects will repeat protocol A and B.

The study's primary objective is to assess whether, compared to placebo, 12 weeks of Empagliflozin improves post-absorptive or postprandial insulin action to enhance myocardial perfusion (MP) and whether changes of MP correlate with improved glucose variability or postprandial hyperglycemia

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Empagliflozin + insulin infusion
vascular measurements in overnight fasted state and during insulin infusion
Drug: Empagliflozin 25 MG
SGLT-2 inhibitor
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)
Drug: Empagliflozin 25 MG
SGLT-2 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial microvascular perfusion
Time Frame: Between baseline and 12 weeks treatment
Vascular measure of myocardial perfusion
Between baseline and 12 weeks treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow Mediated Dilation (FMD) Vascular measure of conduit artery stiffness Change in Flow Mediated Dilation (FMD) between baseline and after 2 hour insulin clamp Vascular measure of conduit artery stiffness Flow Mediated Dilation ( FMD)
Time Frame: Between baseline and 12 weeks of treatment.
Vascular measure of conduit artery stiffness
Between baseline and 12 weeks of treatment.
Augmentation Index ( AI)
Time Frame: Between baseline and 12 weeks of treatment.
Measurement of central artery stiffness
Between baseline and 12 weeks of treatment.
Pulse Wave Velocity ( PWV)
Time Frame: Between baseline and 12 weeks of treatment
Measurement of central artery stiffness
Between baseline and 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Eugene J Barrett, MD PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Anticipated)

October 30, 2023

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 18, 2019

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21403
  • 1R01HL142250-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type2 Diabetes

Clinical Trials on Empagliflozin 25 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe