Actively Recruiting

Phase 1
Age: 30Years - 75Years
All Genders
NCT07053319

SGLT2i, Pioglitazone, and Ketone Production in T2D

Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-05-12

64

Participants Needed

1

Research Sites

59 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

To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).

CONDITIONS

Official Title

SGLT2i, Pioglitazone, and Ketone Production in T2D

Who Can Participate

Age: 30Years - 75Years
All Genders

Eligibility Criteria

Eligible

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 below 145/85 mmHg
  • General good health based on medical history, physical exam, blood tests, thyroid function, electrocardiogram, and urinalysis
  • Stable body weight within ±1.5 kg over the last 3 months
  • Not participating in an excessively heavy exercise program
  • Currently treated with diet, sulfonylurea, metformin, or both sulfonylurea and metformin
  • If on statin therapy, dose must be stable for at least 3 months
Not Eligible

You will not qualify if you...

  • Treatment with glucagon-like peptide 1 receptor agonists, dipeptidyl peptidase IV inhibitors, thiazolidinediones, or insulin
  • Use of 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
  • Presence of blood in urine (hematuria)
  • Women of childbearing potential not using appropriate contraceptive methods

AI-Screening

AI-Powered Screening

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

4

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