RecruitingPhase 1NCT05960656

SGLTi, Hepatic Glucose Production and Ketogenesis

Protocol l: SGLT2 Inhibitors, Ketogenesis, and Ketoacidosis

Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

30 participants

Start Date

Oct 5, 2023

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

Summary

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.

Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how a class of diabetes medications called SGLT2 inhibitors (also called gliflozins, such as empagliflozin or dapagliflozin) affect the liver's production of glucose and the body's production of ketones (fats used as fuel). Understanding these mechanisms may help improve diabetes treatment. **You may be eligible if...** - You are 30 to 75 years old with Type 2 diabetes - Your HbA1c (blood sugar average) is between 7.0% and 11% - Your kidney function is adequate (eGFR above 60) - You manage your diabetes with diet, metformin, or a sulfonylurea - Your weight has been stable and you do not do intense exercise **You may NOT be eligible if...** - You use GLP-1 agonists (e.g., semaglutide, liraglutide), DPP-4 inhibitors, thiazolidinediones, or insulin - You have significant kidney disease or advanced eye complications from diabetes - You are a woman of childbearing potential not using contraception 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.

OTHERPlacebo

Inert tablet