SGLT2 Inhibitors, Ketogenesis, & Ketoacidosis

Status Recruiting

Clinical Trial Summary

The purpose of this study is to examine the effect of empagliflozin, with and without pancreatic clamp, on endogenous (hepatic) glucose production (EGP, or 6,6, D2-glucose), gluconeogenesis (D2O), lipolysis (U-2H-glycerol), ketogenesis (13C-palmitate conversion to 3-betahydroxybutyrate), and norepinephrine turnover (3H-NE) in type 2 diabetes subjects.

Clinical Trial Description

After confirming eligibility, subjects will be randomized to receive empagliflozin (n=20) or placebo (n=10) in 2:1 ratio. Subject stratification will be done according to the following parameters: age (> or < 50 y), BMI (> or < 30 kg/m2), eGFR (> or < 80 ml/min/1.73 m2), HbA1c (> or < 8.5%). Each subject will participate in two studies performed in random order with 10-21 day interval between studies. Background medications (MET and/or SU) will be withheld on the morning of study. In Study 1, EGP will be measured with a prime-continuous 6,6, D2-glucose infusion and lipolysis will be measured with prime-continuous infusion of U-2H-glycerol. The rate of ketogenesis will be determined by infusion of 13C palmitate and quantitating the enrichment of 13C in 3-hydroxybutyrate (b-OHB). Total body NE turnover will be measured with 3H-norepinephrine (3H-NE) infusion before and after empagliflozin administration. Study 2 will be similar to Study 1 with one exception. EGP, lipolysis, and ketogenesis, and NE turnover will be measured under pancreatic clamp conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05960656
Study type	Interventional
Source	The University of Texas Health Science Center at San Antonio
Contact	Ralph DeFronzo, MD
Phone	210-567-6691
Email	defronzo@uthscsa.edu
Status	Recruiting
Phase	Early Phase 1
Start date	October 5, 2023
Completion date	June 30, 2027

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SGLT2 Inhibitors, Ketogenesis, and Ketoacidosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms