SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia
Part of paid clinical trials in San Antonio, Texas.
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Study ID
- NCT07053306
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Empagliflozin 25 MG — DRUGA 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.
Study Details
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.
Key Dates
- Start date
- Apr 29, 2025
- Status verified
- Jul 2025
- Primary completion
- Jun 1, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 29 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: EmpagliflozinEmpagliflozin 25 mg/day
Primary Outcome Measure
Ketone Body Turnover (ketogenesis) [ Time Frame: 0 and 300 minutes ]
Central Contacts
- Ralph DeFronzo, MD210-567-6691
- Aurora Merovci, MD210-567-6691
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Texas Diabetes Institute/UH | San Antonio | Texas | 78229-3900 | Ralph DeFronzo, MD (PRINCIPAL_INVESTIGATOR) |
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