Actively Recruiting
SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-07-11
29
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with type 2 diabetes
- Ages 30 to 75 years
- Body Mass Index (BMI) between 21 and 45 kg/m2
- Hemoglobin A1C (HbA1c) between 7.0% and 11%
- Estimated glomerular filtration rate (eGFR) greater than 60 ml/min/1.73m2
- Blood pressure below 160/90 mmHg
- General good health based on medical history, physical exam, blood tests, thyroid tests, ECG, and urinalysis
- Stable body weight within ±1.5 kg over the last 3 months
- Not participating in heavy exercise programs
- Currently treated with diet, sulfonylurea, metformin, or combination of sulfonylurea/metformin
- Stable statin therapy for at least 3 months if applicable
You will not qualify if you...
- Treatment with GLP-1 receptor agonists, DPP-4 inhibitors, thiazolidinediones, or insulin
- Use of medications other than sulfonylurea or metformin that affect glucose metabolism
- Evidence of proliferative retinopathy
- Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2
- Women of childbearing potential not using appropriate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Texas Diabetes Institute/UH
San Antonio, Texas, United States, 78229-3900
Actively Recruiting
Research Team
R
Ralph DeFronzo, MD
CONTACT
A
Aurora Merovci, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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