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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

Study acronym: DESIGN
StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated May 21, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT06983054
Lead Sponsor Amsterdam UMC, location VUmc
Collaborators: Children's Hospital Colorado
Conditions
(from sponsor)
Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov