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NCT05960656 · ClinicalTrials.gov registry record · Phase 1
SGLTi, Hepatic Glucose Production and Ketogenesis
A Phase 1 study of Type 2 Diabetes, sponsored by The University of Texas Health Science Center at San Antonio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05960656 is a Phase 1 study of Type 2 Diabetes that is actively recruiting participants, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 30 participants, below the 1,103-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05960656, a Phase 1 study of Type 2 Diabetes, is actively recruiting participants, sponsored by The University of Texas Health Science Center at San Antonio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, we 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) and type 1 diabetes (T1D), and that the increases in ketone production and lipolysis can be prevented by concomitant administration of the thiazolidinedione pioglitazone. We will conduct five distinct experiments to test this hypothesis in patients with T2D and T1D. MAIN STUDY: To examine the effect of empagliflozin versus empagliflozin/pancreatic clamp on EGP (6,6, D2-glucose), gluconeogenesis (D2O), lipolysis (U-2H-glycerol), ketogenesis (13C-palmitate conversion to 3-betahydroxybuyrate), and norepinephrine turnover (3H-NE) in type 2 diabetes subjects.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Empagliflozin 25 MG
Study Locations (1)
Texas
- Texas Diabetes Institute/UH - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-10-05 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05960656
The ClinicalTrials.gov registry entry for NCT05960656 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,103-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (97% lower). The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05960656 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05960656 about?
NCT05960656 is a clinical study titled "SGLTi, Hepatic Glucose Production and Ketogenesis". In this study, we 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) and type 1 diabetes (T1D), and that the increases in ketone production and...
What is the current status of trial NCT05960656?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-10-05. Estimated completion is 2027-06-30.
What conditions does trial NCT05960656 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT05960656?
The interventions under investigation include: Placebo (OTHER), Empagliflozin 25 MG (DRUG).
Who is sponsoring clinical trial NCT05960656?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05960656 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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