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NCT04401904 · ClinicalTrials.gov registry record · Phase 1
SGLT2 Inhibition in Older Obese Adults With Pre-diabetes
A Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04401904: Completed Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT04401904 is a Phase 1 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04401904, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Inhibitors of the sodium-glucose co-transporter (SGLT2) are FDA-approved for the treatment of type 2 diabetes (T2DM). Their mechanism of action involves lowering of blood glucose concentration secondary to increased glucose excretion of glucose by the kidney. These drugs also improve body weight, blood pressure, and cardiac function. Based on these pleiotropic effects, including its calorie restriction-mimetic properties, the study team hypothesize that SGLT2 drugs will impact several basic aging-related processes, including reductions in oxidative damage to DNA and proteins, advanced glycation end products (AGE) and receptor for AGE (RAGE), cellular senescence, and mitochondrial function.
Primary Outcome
Change in AGE-RAGE measured by enzyme-linked immunosorbent assay (ELISA).
Interventions
- BEHAVIORAL Nutritional counseling
- DRUG Dapagliflozin 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-06-25 |
| Est. Completion | 2022-09-14 |
| Phase | Phase 1 |
What the finished NCT04401904 record still lists
NCT04401904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Nutritional counseling is the first listed.
NCT04401904 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04401904 about?
NCT04401904 is a clinical study titled "SGLT2 Inhibition in Older Obese Adults With Pre-diabetes". Inhibitors of the sodium-glucose co-transporter (SGLT2) are FDA-approved for the treatment of type 2 diabetes (T2DM). Their mechanism of action involves lowering of blood glucose concentration secondary to increased glucose excretion of glucose by the kidney. These drugs also improve body weight, bl...
What is the current status of trial NCT04401904?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-06-25. Estimated completion is 2022-09-14.
What interventions are being tested in trial NCT04401904?
The interventions under investigation include: Nutritional counseling (BEHAVIORAL), Dapagliflozin 10 mg (DRUG).
Who is sponsoring clinical trial NCT04401904?
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04401904's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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