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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: Recruiting Phase 4 study of Type 2 Diabetes, sponsored by Amsterdam UMC, location VUmc.
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 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To investigate the modifying effects of WHO-recommended sodium intake (90 mmol per day) vs. high sodium intake (targeted at 250 mmol per day) on the effect of ertugliflozin 15 mg daily, versus placebo, on 24-hour blood pressure in overweight/obese adults with type 2 diabetes.
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 |
What NCT06983054 shows while recruiting
NCT06983054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06983054's enrollment target sits among peer trials
34 250th of 327 higher than 76 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes 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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