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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
Texas Diabetes Institute/UH
RECRUITING
San Antonio
Contact Information
Primary
Ralph DeFronzo, MD
defronzo@uthscsa.edu
210-567-6691
Backup
Aurora Merovci, MD
merovci@uthscsa.edu
210-567-6691
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 29
Treatments
Experimental: Empagliflozin
Empagliflozin 25 mg/day
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov