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RECRUITING
NCT05960656
PHASE1

SGLTi, Hepatic Glucose Production and Ketogenesis

Sponsor: The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

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.

Official title: Protocol l: SGLT2 Inhibitors, Ketogenesis, and Ketoacidosis

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-10-05

Completion Date

2027-06-30

Last Updated

2025-07-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Empagliflozin 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.

OTHER

Placebo

Inert tablet

Locations (1)

Texas Diabetes Institute/UH

San Antonio, Texas, United States