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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Amsterdam UMC, location VUmc
Study ID
NCT06983054
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • ertugliflozine — DRUG
    SGLT2i versus placebo
  • low salt diet — BEHAVIORAL
    comparing low salt versus high salt diet
  • placebo — DRUG
    placebo tablet
  • high salt diet — BEHAVIORAL
    high salt diet

Study Details

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.

Key Dates

Start date
Jul 25, 2023
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Low salt diet with SGLT2i
    10 days of SGLT2i treatment during 20 days of low salt diet
  • Placebo Comparator: Low salt diet with placebo
    10 days of placebo during 20 days of low salt diet
  • Active Comparator: High salt diet with SGLT2i
    10 days of SGTL2i during 20 days of high salt diet.
  • Placebo Comparator: High salt diet with placebo
    10 days of placebo during 20 days of high salt diet.

Primary Outcome Measure

Blood pressure [ Time Frame: 7 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Childrens hospital coloradoDenverColorado80045
Jessica Kendrick, Prof.
[email protected]
303-724-4837

Find similar trials in Denver, CO

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Childrens hospital colorado· Denver, CO

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