NCT07053293 SGLT2i, Hepatic Glucose Production, and SNS
| NCT ID | NCT07053293 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 22 participants in total. It began in 2025-01-07 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study, PI will test the hypothesis that distinct mechanisms account for the SGLT2i-induced stimulation of ketogenesis and lipolysis versus endogenous (hepatic) glucose production in patients with type 2 diabetes (T2D) that the increases in ketone production and lipolysis can be prevented by concomitant administration of the thiazolidinedione pioglitazone. Principal Investigator (PI) will conduct five distinct experiments to test this hypothesis in patients with T2D. To examine the role of the SNS on the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D by comparing the effect of empagliflozin versus empagliflozin plus propranolol.
Eligibility Criteria
Patients with T2D Inclusion Criteria: * 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 Exclusion Criteria: * Patients treated with Glucagon-like peptide 1 receptor agonists (GLP-1 RA), Dipeptidyl Peptidase IV inhibitors (DPP-4i), Thiazolidinediones (TZD), or insulin are excluded * Patients taking medications (other than SU/MET) known to affect glucose metabolism are excluded * Subjects with evidence of proliferative retinopathy or eGFR \< 60 are excluded * Women of childbearing potential are excluded unless they are taking/using appropriate contractive medications/devices
Contact & Investigator
Ralph DeFronzo, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT07053293 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07053293 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07053293 currently recruiting?
Yes, NCT07053293 is actively recruiting participants. Contact the research team at defronzo@uthscsa.edu for enrollment information.
Where is the NCT07053293 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT07053293 clinical trial?
NCT07053293 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Ralph DeFronzo, MD at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 22 participants.
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