RecruitingPhase 1NCT07053306

SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia

Protocol III: SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

29 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To examine the 2-HIT hypothesis that the SGLT2i-induced stimulation of EGP, lipolysis, and ketone production requires the combination of volume depletion plus insulinopenia in T2D individuals.


Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at a rare but serious side effect of SGLT2 inhibitor medications (used for diabetes and heart failure) called diabetic ketoacidosis (DKA) — a dangerous buildup of acids in the blood. Researchers want to understand how factors like low insulin and dehydration contribute to this risk so it can be better prevented. **You may be eligible if...** - You are taking or have taken an SGLT2 inhibitor medication for diabetes or heart failure - You are willing to participate in study procedures to measure ketone and insulin levels - You meet the age and health requirements **You may NOT be eligible if...** - You have type 1 diabetes - You have severe kidney disease - You have conditions that make the study procedures unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 25 MG

A medication used in the management and treatment of type 2 diabetes mellitus. It is in the sodium-glucose co-transporter (SGLT-2) class of medications.


Locations(1)

Texas Diabetes Institute/UH

San Antonio, Texas, United States

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NCT07053306


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