RecruitingPhase 1NCT07053306

SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia

Protocol III: SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia

Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

29 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

Summary

To examine the 2-HIT hypothesis that the SGLT2i-induced stimulation of EGP, lipolysis, and ketone production requires the combination of volume depletion plus insulinopenia in T2D individuals.

Eligibility

Min Age: 30 YearsMax Age: 75 Years

Inclusion Criteria10

Patients with T2D
Ages 30-75 years
Body Mass Index (BMI) 21-45 kg/m2
Hemoglobin A1C (HbA1c) = 7.0-11%
Estimated glomerular filtration rate (eGFR) \> 60 ml/min/1.73m2
Blood Pressure (BP) \< 160/90 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 Criteria4

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

Interventions

DRUGEmpagliflozin 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.