How a diabetes pill affects ketones and the risk of ketoacidosis
SGLT2 Inhibitors, Ketogenesis, and Ketoacidosis
Researchers will look at how the diabetes medicine empagliflozin changes ketone production and liver glucose release in adults with diabetes and whether adding pioglitazone can prevent those effects.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Texas Hlth Science Center NIH-funded |
| Lab location | 1 site (San Antonio, United States) |
| Project ID | NIH-11137783 on NIH RePORTER |
What this research studies
If you take part, you'll receive empagliflozin and have blood tests that measure ketone levels and how much glucose your liver makes using safe isotope tracers. The team will run several short inpatient or outpatient protocols to track changes in ketones and hepatic glucose production over time. In later parts, participants may also receive pioglitazone to see if it prevents the rise in ketones and liver glucose output caused by empagliflozin. Visits will include blood draws, medication dosing, and monitoring for any signs of ketoacidosis.
Who could benefit from this research
Good fit: Adults with type 1 or type 2 diabetes who are willing to take empagliflozin (and possibly pioglitazone), undergo blood draws, and attend study visits at the clinical site would be ideal candidates.
Not a fit: People without diabetes, pregnant individuals, those with severe kidney disease, or those unwilling to undergo frequent blood testing and clinic visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: This work could make SGLT2 inhibitor treatment safer by reducing the risk of ketoacidosis and allow more people with diabetes to benefit from these drugs.
How similar studies have performed: SGLT2 inhibitors already show clear heart and kidney benefits, but using isotope tracer techniques to pinpoint why they raise ketones and testing whether pioglitazone blocks that effect is a relatively new and more detailed approach.
Where this research is happening
San Antonio, United States
- University of Texas Hlth Science Center — San Antonio, United States (Active)
Researchers
- Principal investigator: Defronzo, Ralph a — University of Texas Hlth Science Center
- Study coordinator: Defronzo, Ralph a
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.