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NCT06983054 · ClinicalTrials.gov registry record · Phase 4
DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study, a Randomized, Placebo-controlled, Cross-over Study With Ertugliflozin in People With Type 2 Diabetes
A Phase 4 study of Type 2 Diabetes, sponsored by Amsterdam UMC, location VUmc.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
- 2
- Study locations
NCT06983054 is a Phase 4 study of Type 2 Diabetes that is actively recruiting participants, run by Amsterdam UMC, location VUmc. The registered enrollment target is 34 participants, below the 1,103-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06983054, a Phase 4 study of Type 2 Diabetes, is actively recruiting participants, sponsored by Amsterdam UMC, location VUmc.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
- 2
- Study locations
Study Summary
SGLT2 inhibitors have demonstrated to mitigate cardiorenal risk in people with type 2 diabetes and are likely to play an increasingly large role in the treatment of patients with diabetes, chronic kidney disease and hypertension. Yet the underlying mechanisms of its protective effects are incompletely understood and the salutary effect may be altered by dietary factors such as sodium intake. Therefore, carefully designed mechanistic trials are needed to better understand the interplay between ertugliflozin and salt intake and to potentially modify salt intake to maximize treatment response. In addition, the study could contribute to hypotheses concerning the effects of SGLT2 inhibitors in combination with other drugs that affect sodium homeostasis and could help to explain the differences in kidney outcomes observed in (outcome) trials, which include different ethnicities with potential differences in dietary habits.
Conditions Studied
Interventions
- DRUG placebo
- DRUG ertugliflozine
- BEHAVIORAL low salt diet
- BEHAVIORAL high salt diet
Study Locations (2)
Colorado
- Childrens hospital colorado - Denver
Other
- Amsterdam UMC - Amsterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2023-07-25 |
| Est. Completion | 2025-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06983054
The ClinicalTrials.gov registry entry for NCT06983054 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 34 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 Amsterdam UMC, location VUmc, which has 1 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 4 interventions - of which placebo is the first listed.
NCT06983054 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Other.
Frequently Asked Questions
What is clinical trial NCT06983054 about?
NCT06983054 is a clinical study titled "DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study, a Randomized, Placebo-controlled, Cross-over Study With Ertugliflozin in People With Type 2 Diabetes". SGLT2 inhibitors have demonstrated to mitigate cardiorenal risk in people with type 2 diabetes and are likely to play an increasingly large role in the treatment of patients with diabetes, chronic kidney disease and hypertension. Yet the underlying mechanisms of its protective effects are incomplete...
What is the current status of trial NCT06983054?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2023-07-25. Estimated completion is 2025-12.
What conditions does trial NCT06983054 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT06983054?
The interventions under investigation include: placebo (DRUG), ertugliflozine (DRUG), low salt diet (BEHAVIORAL), high salt diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT06983054?
This trial is sponsored by Amsterdam UMC, location VUmc, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06983054 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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