SGLT2 Inhibitors, Ketogenesis, and Ketoacidosis

• Status: Recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Ages 30-75 years

• Body Mass Index (BMI) 21-45 kg/m2

• Hemoglobin A1C (HbA1c) = 7.0-10%

• Estimated glomerular filtration rate (eGFR) > 60 ml/min/1.73m2

• Blood Pressure (BP) < 145/85 mmHg

• Participants must be in general good health based on medical history, physical exam, screening blood chemistries, complete blood chemistry (CBC), thyroid stimulating hormone/thyroxine (TSH/T4), electrocardiogram (EKG), and urinalysis

• Stable body weight (±1.5 kg) over the last 3 months and must not participate in an excessively heavy exercise program

• Patients treated with diet, sulfonylurea (SU), metformin (MET), or SU/MET

• Statin therapy is permissible if the dose has been stable for at least 3 months

Exclusion Criteria:

• Patients treated with Glucagon-like peptide 1 receptor agonists (GLP-1 RA), Dipeptidyl Peptidase IV inhibitors (DPP-4i), Thiazolidinediones (TZD), or insulin are excluded

• Patients taking medications (other than SU/MET) known to affect glucose metabolism are excluded

• Subjects with evidence of proliferative retinopathy or eGFR < 60 are excluded

• Women of childbearing potential are excluded unless they are taking/using appropriate contractive medications/devices