Empagliflozin, Hepatic Glucose Production, and SNS in Type 2 Diabetes

This study is investigating how empagliflozin (a medication for type 2 diabetes) affects the body's sugar production (Endogenous Glucose Production or EGP), fat breakdown (lipolysis), and ketone production in people with type 2 diabetes. Researchers want to understand if different processes control these effects and if another medication, pioglitazone, can prevent some of these changes. They will also look at the role of the sympathetic nervous system (SNS) by comparing empagliflozin alone versus empagliflozin with propranolol. You may be eligible if you are 30-75 years old, have type 2 diabetes, and meet certain health criteria, including an HbA1c between 7.0-11% and an eGFR (a measure of kidney function) greater than 60. The main goal is to measure EGP at 0 and 300 minutes. The current status of this study is unclear.

Study design
This interventional study plans to enroll 22 participants with type 2 diabetes. Participants will be randomized to receive empagliflozin.
What's involved
You would participate in two studies performed in random order, involving infusions to measure glucose production, fat breakdown, and ketone production, as well as blood tests and an EKG.
Compensation
Not stated in the trial record.
Follow-up
Measurements for the primary endpoint (Endogenous Glucose Production) are taken at 0 and 300 minutes after empagliflozin administration.

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NCT07053293

SGLT2i, Hepatic Glucose Production, and SNS

Recruiting
EARLY_PHASE1Ages 30–75InterventionalBasic science
The University of Texas Health Science Center at San Antonio
~22 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Empagliflozin 25 MG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Endogenous Glucose Production (EGP)
Measured over 0 and 300 minutes
Type 2 Diabetes
1 sites across 1 states
Texas1
  • Ralph DeFronzo, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

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Eligibility criteria

Inclusion

Ages 30-75
BMI (Body Mass Index) 21-45 kg/m2
HbA1c = 7.0-11%
eGFR (estimated glomerular filtration rate)\> 60 ml/min/1.73m2
Blood Pressure (BP)≤160/90 mmHg
Participants must be in general good health based on medical history, physical exam, screening blood chemistries, CBC (Complete Blood Count), TSH/T4 (thyroid/thyroxine hormone), EKG (electrocardiogram), and urinalysis (UA)
Stable body weight (±1.5 kg) over the last 3 months and must not participate in an excessively heavy exercise program
Patients treated with diet, Sulfonylureas, Metformin, or Sulfonylureas/Metformin (Sulfo/MET)
Participants receiving a Glucagon like peptide -1 receptor agonist (GLP1-RA) must be on a stable dose for at least three months prior to study enrollment.
Participants receiving a Dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitor) must be on a stable dose for at least two months prior to study enrollment.
SGLT2 inhibitors must be discontinued at least two months prior to study enrollment.

Exclusion

Patients treated with Thiazolidinediones (TZDs), or Insulin are excluded.
Patients taking medications other than Sulfonylureas/Metformin (SU/MET), stable dose of GLP1-RA and DPP4i known to affect glucose metabolism are excluded. Patients taking SGLT2i within 2 months of screening visit will be excluded from participating in this study, however they may be asked whether they would agree to discontinue the medication for two months to become eligible. (Please see clarification below.) \*
Subjects with evidence of proliferative retinopathy or estimated glomerular filtration rate (eGFR) \< 60 are excluded
Women of childbearing potential are excluded unless they are taking/using appropriate contractive medications/devices \* Only participants who are taking SGLT2 inhibitors during the prescreening period will be asked to discontinue the medication at least two months prior to the screening visit. If they agree, they will return for an HbA1c measurement four weeks after stopping the SGLT2 inhibitor.
  • Endogenous Glucose Production (EGP)0 and 300 minutes

    Measurement of Endogenous Glucose Production (EGP) using stable isotope (6,6, D2- glucose infusion).