Clinical Trial

SGLTi, Hepatic Glucose Production and Ketogenesis

Recruiting Phase 1
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-07-21; most recent amendment 2026-07-15.
Status change: Not Yet Recruiting → Recruiting 2023-10-18
Trial Details
NCT Number NCT05960656
Lead Sponsor The University of Texas Health Science Center at San Antonio
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type 2 Diabetes
Enrollment 30 participants
Start Date 2023-10-05
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-17