Actively Recruiting

Phase 1
Age: 30Years - 75Years
All Genders
NCT05960656

SGLTi, Hepatic Glucose Production and Ketogenesis

Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-07-01

30

Participants Needed

1

Research Sites

194 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, we 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) and type 1 diabetes (T1D), and that the increases in ketone production and lipolysis can be prevented by concomitant administration of the thiazolidinedione pioglitazone. We will conduct five distinct experiments to test this hypothesis in patients with T2D and T1D. MAIN STUDY: To examine the effect of empagliflozin versus empagliflozin/pancreatic clamp on EGP (6,6, D2-glucose), gluconeogenesis (D2O), lipolysis (U-2H-glycerol), ketogenesis (13C-palmitate conversion to 3-betahydroxybuyrate), and norepinephrine turnover (3H-NE) in type 2 diabetes subjects.

CONDITIONS

Official Title

SGLTi, Hepatic Glucose Production and Ketogenesis

Who Can Participate

Age: 30Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 30 to 75 years
  • Body Mass Index (BMI) between 21 and 45 kg/m2
  • Hemoglobin A1C (HbA1c) between 7.0% and 11%
  • Estimated glomerular filtration rate (eGFR) above 60 ml/min/1.73m2
  • Blood pressure below 160/90 mmHg
  • General good health based on medical history, physical exam, blood tests, thyroid tests, EKG, and urinalysis
  • Stable body weight within ±1.5 kg over the last 3 months
  • Not participating in excessively heavy exercise programs
  • Treated with diet, sulfonylurea (SU), metformin (MET), or combination SU/MET
  • Stable statin therapy dose for at least 3 months if applicable
Not Eligible

You will not qualify if you...

  • Treated with GLP-1 receptor agonists, DPP-4 inhibitors, thiazolidinediones, or insulin
  • Taking medications other than SU/MET that affect glucose metabolism
  • Evidence of proliferative retinopathy or eGFR below 60 ml/min/1.73m2
  • Women of childbearing potential not using appropriate contraceptive methods

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Texas Diabetes Institute/UH

San Antonio, Texas, United States, 78229-3900

Actively Recruiting

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Research Team

R

Ralph DeFronzo, MD

CONTACT

A

Aurora Merovci, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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