RecruitingPhase 1

SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia

United States29 participantsStarted 2025-04-29

Plain-language 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.

Who can participate

Age range

30 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patients with T2D Inclusion Criteria: * Ages 30-75 * BMI (Body Mass Index) 21-45 kg/m2 * HbA1c = 7.0-11% * eGFR (estimated glomerular filtration rate)\> 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, CBC (Complete Blood Count), TSH/T4 (thyroid/thyroxine hormone), EKG (electrocardiogram), and urinalysis (UA) * 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, Sulfonylureas, Metformin, or Sulfonylureas/Metformin (Sulfo/MET) * Participants receiving a Glucagon like peptide -1 receptor agonist (GLP1-RA) must be on a stable dose for at least three months prior to study enrollment. * Participants receiving a Dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitor) must be on a stable dose for at least two months prior to study enrollment. * SGLT2 inhibitors must be discontinued at least two months prior to study enrollment. * Statin therapy is permissible if the dose has been stable for at least 3 months EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: * Patients treated with Thiazolidinediones (TZDs), or Insulin are excluded. * Patients taking medications other than Sulfonylureas/Metformin (SU/MET), stable dose of GLP1-RA and DPP4i known to affect glucose metabolism are excluded. Patients taki…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 1 trial studying how SGLT2 inhibitors affect ketone production in people with Type 2 diabetes — what does that mean for my safety, and what is still unknown at this early stage?
2The trial is specifically looking at ketoacidosis risk, which can be a serious condition — given my current diabetes management, am I at higher risk of developing ketoacidosis if I participate?
3The study involves something called 'volume contraction' and 'insulinopenia,' which sound like they involve intentional fluid or insulin changes — what exactly would be done to my body during this study, and what monitoring would be in place?
4Since this is a research study measuring ketone body turnover rather than testing a treatment meant to benefit me directly, would participating add anything to my own care, or would standard treatment be a better focus for me right now?
5The trial is actively recruiting — if I were to discuss joining with you, how would my current SGLT2 inhibitor use or insulin regimen affect whether this study would even be appropriate for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ketone Body Turnover (ketogenesis)

Timeframe: 0 and 300 minutes

Trial details

NCT IDNCT07053306

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Ralph DeFronzo, MD

210-567-6691 defronzo@uthscsa.edu

View on ClinicalTrials.gov More Type 2 Diabetes trials

Who can participate

Age range

30 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.