Actively Recruiting
SGLT2i, Hepatic Glucose Production, and SNS
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-07-11
22
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this study, PI will test the hypothesis that distinct mechanisms account for the SGLT2i-induced stimulation of ketogenesis and lipolysis versus endogenous (hepatic) glucose production in patients with type 2 diabetes (T2D) that the increases in ketone production and lipolysis can be prevented by concomitant administration of the thiazolidinedione pioglitazone. Principal Investigator (PI) will conduct five distinct experiments to test this hypothesis in patients with T2D. To examine the role of the SNS on the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D by comparing the effect of empagliflozin versus empagliflozin plus propranolol.
CONDITIONS
Official Title
SGLT2i, Hepatic Glucose Production, and SNS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 30 to 75 years
- Diagnosis of type 2 diabetes
- Body mass index (BMI) between 21 and 45 kg/m2
- Hemoglobin A1C (HbA1c) between 7.0% and 11%
- Estimated glomerular filtration rate (eGFR) greater than 60 ml/min/1.73m2
- Blood pressure less than 160/90 mmHg
- General good health based on medical history, physical exam, blood tests, thyroid tests, electrocardiogram, and urinalysis
- Stable body weight (±1.5 kg) over the last 3 months and no participation in excessively heavy exercise programs
- Treated with diet, sulfonylurea, metformin, or combination of sulfonylurea and metformin
- Stable statin therapy for at least 3 months if applicable
You will not qualify if you...
- Treated with glucagon-like peptide 1 receptor agonists (GLP-1 RA), dipeptidyl peptidase IV inhibitors (DPP-4i), thiazolidinediones (TZD), or insulin
- Taking medications other than sulfonylurea or metformin that affect glucose metabolism
- Evidence of proliferative retinopathy
- Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2
- Women of childbearing potential not using appropriate contraceptive methods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Texas Diabetes Institute/UH
San Antonio, Texas, United States, 78229-3900
Actively Recruiting
Research Team
R
Ralph DeFronzo, MD
CONTACT
A
Aurora Merovci, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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