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Type 2 DiabetesGut healthMetabolicDrugPhase 1

What this study is

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.

What's being tested

  • Empagliflozin 25 MG

    Intervention · DRUG

    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.

  • Placebo

    Intervention · OTHER

    Inert tablet

Study details

Official title
Protocol l: SGLT2 Inhibitors, Ketogenesis, and Ketoacidosis
Sponsor
The University of Texas Health Science Center at San Antonio
Conditions
Type 2 Diabetes
Enrolling
30 people
Starts
2023-10-05
Est. completion
2027-06-30
Design
Triple-blind, randomized, parallel groups, Phase 1
Record
View on ClinicalTrials.gov ↗